[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treatment":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,44,78,112,135,167,195,221,246,275,300,331,357,386,407,424,445,462,485,509,530,554,579,599,616],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100525189","a-clinical-trial-of-adaptive-treatment-for-early-smoking-cessation-relapse-100525189",false,"NCT06118502","A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse","ADAPT","Inclusion Criteria:\n\n* Smokers who want to quit\n\nExclusion Criteria:\n\n* Non-smokers",true,"ALL","21 Years",{"count":21,"type":22},544,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.\n\nAll visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.",[28,29,30],"Cigarette Smoking","Smoking Behaviors","Treatment","RECRUITING","2026-08-10",{"date":34,"type":35},"2026-08-12","ACTUAL",{"date":37,"type":35},"2024-03-25",{"date":39,"type":22},"2028-03-31",{"name":41,"class":42},"Medical University of South Carolina","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":43},"100648439","phase-2-effect-of-melatonin-administration-on-systemic-lupus-erythematosus-patients-100648439","NCT07721324","Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients","Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients","SLE","Inclusion Criteria:\n\n* Adult male and female patients with active SLE aged 18-60 years\n* Active SLE patients defined on SLEDAI-2K score to be (more than or equal 4 up to 11) according to the classification of SLE as suggested by the American Rheumatology Association (American College of Rheumatology)\n* Have had non-life-threatening disease\n* Taking stable doses of medications for SLE treatment in the last three months\n* Ability and willingness to cooperate in the study\n\nExclusion Criteria:\n\n* Other autoimmune diseases\n* Uncontrolled hypertension or Uncontrolled DM\n* Severe renal (GFR \\\u003C 30 ml\u002Fmin ) or severe liver diseases (ALT or AST \\\u003C3 times ULN or total bilirubin \\> 2 times ULN)\n* Life-threatening SLE including\n\n  * Severe hemolysis (reticulocyte count \\>8%)\n  * Severe thrombocytopenia (platelet count \\\u003C40 000)\n  * Endocarditis\n  * Lupus pneumonia\n  * Alveolar hemorrhage\n* Using sedations, antidepressants, contraceptives, antioxidant and\u002For omega-3-fatty acid supplements one month prior to or during the study\n* Smoking and\u002F or alcohol intake\n* Allergy to melatonin\n* Pregnancy, pregnancy plans and lactation.\n* Having active infectious diseases\n* poor patient compliance\n* Any sleeping pills two weeks prior to the study\n* Malabsorption syndromes\n* Malignancy\n* Warfarin or heparin use or high-dose aspirin (more than 325 mg\u002Fday)\n* Stroke","18 Years","60 Years",{"count":55,"type":22},64,[57,58],"PHASE2","PHASE3","The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.",[61,30],"Therapy",[63,64,65,66,67],"Melatonin","Systemic Lupus Erythematosus","Inflammation","Fatigue","SLEQoL","NOT_YET_RECRUITING","2026-07-18",{"date":71,"type":35},"2026-07-23",{"date":73,"type":22},"2026-07-21",{"date":75,"type":22},"2026-11-21",{"name":77,"class":42},"Ain Shams University",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":17,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100647147","treatment-of-mandibular-overjet-in-children-with-maxillary-retrognathism-100647147","NCT07706400","Treatment of Mandibular Overjet in Children With Maxillary Retrognathism","Inclusion Criteria:\n\n* Mandibular overjet due to maxillary retrognathia (Overjet \\\u003C\u002F= 0 mm)\n* Age 9-12 years\n* Informed consent from parents\u002Fguardians\n\nExclusion Criteria:\n\n* Mandibular overjet mainly due to mandibular prognathism\n* Known general and\u002For craniofacial syndromes\u002Fdiseases\n* Adenoid vegetations, hypertrophic tonsils and significantly reduced air passage through nose (mouth breathing), which must be primarily treated\n* Functional disorders in muscles and jaw joints, which must be primarily treated","9 Years","12 Years",{"count":87,"type":22},180,[25],"The project involves a 10-year prospective longitudinal cohort multicentre study where orthodontic treatment and treatment effect is followed in children with Cl III due to maxillary retrognathia who undergo standardized orthodontic interceptive treatment. Standard clinical procedures are followed as usual at each clinic where standard diagnostic and follow up materials are taken before treatment, after treatment and follow ups after 5 and 10 years. The project will not introduce or test new treatment modalities, additional procedures or behavioural regulation in relation to normal clinical practice or new medical devices. The standard diagnostic and follow up materials in each clinic include examination of the dentition, occlusion, craniofacial morphology, and orofacial function. The analyses are based on the following standardized registration methods which are carried out on all the patients. Information from the patient record is included.\n\nThe patient related outcome measurements will be assessed by five different questionnaires. No biological material is collected for the project.",[91,92,30,93],"Maxillary Retrognathism","Children","Class III Malocclusion",[95,96,97,98,99,100,101],"Class III malocclusion","maxillary retrognathism","mixed dentition","children","permanent dentition","maxillofacial surgery","Face mask","2026-07-13",{"date":104,"type":35},"2026-07-15",{"date":106,"type":22},"2026-07-31",{"date":108,"type":22},"2038-07-31",{"name":110,"class":42},"Malmö University",3,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100646201","prevention-of-relapse-through-cognitive-cycling-in-patients-with-alcohol-use-disorder-following-alcohol-withdrawal-100646201","NCT07690423","Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal","Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal: Protocol for the TUA-VelCo Randomised Controlled Trial","TUA-VelCo","Inclusion Criteria:\n\n* adults aged ≥ 18 years\n* patients with a diagnosis of alcohol use disorder (AUD) according to DSM-5 criteria\n* who have been hospitalized for complex withdrawal and aim to maintain abstinence after discharge\n* patients must have preserved cognitive function, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 26\n* patients must provide written informed consent\n\nExclusion Criteria:\n\n* pregnant women\n* patients with unstable psychiatric or somatic conditions\n* with a contraindication to physical activity\n* participants in structured rehabilitation programs during the first month\n* adult under guardianship\n* with inability to understand French or provide informed consent\n* with major neurocognitive disorder\n* with regular physical activity\n* participation in another interventional study interfering with outcomes",{"count":121,"type":22},128,[25],"TUA-VelCo is a single-center randomized controlled superiority trial with blinded methodological assessment. Adult patients hospitalized for alcohol withdrawal and meeting the criteria for Alcohol Use Disorder (AUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition will be eligible for inclusion. Participants will be randomly assigned to either a cognitive cycling intervention group or a control group.\n\nParticipants in the experimental group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks). The control group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions. Assessments will be conducted at baseline, 1 month (M1), and 3 months (M3) following hospital discharge.\n\nThe primary outcome will be the proportion of participants maintaining abstinence at M1. Secondary outcomes include maintenance of abstinence at M3 and within-group and between-group changes in craving, cognitive functioning, insight, psychiatric symptoms, and motivation to maintain abstinent. These outcomes will be assessed using validated scales, including the Obsessive Compulsive Drinking Scale, Montreal Cognitive Assessment, Hanil Alcohol Insight Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scale. Biomarkers related to alcohol consumption and neuroplasticity will also be evaluated.",[125,126,30],"Cognitive Cycling","Alcohol Use Disorder (AUD)","2026-07-08",{"date":129,"type":35},"2026-07-10",{"date":127,"type":22},{"date":132,"type":22},"2027-12-01",{"name":134,"class":42},"Centre Hospitalier Esquirol",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":18,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":154,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":43},"100599263","multidimensional-sleep-health-intervention-to-optimize-concussion-recovery-100599263","NCT07082218","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery","Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial","SCORE","Inclusion Criteria:\n\n* Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory \\[PCSI\\] score ≥9)\n* Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria\n* 10-19 years of age (aligned with World Health Organization definition of 'adolescent')\n\nExclusion Criteria:\n\n* History of treatment for pre-concussion sleep-related disorders","10 Years","19 Years",{"count":146,"type":22},54,[25],"Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.",[150,151,30,152,153],"Concussion (Diagnosis)","Concussion, Mild Traumatic Brain Injury","Sleep Health","Depression, Anxiety",[155,156,157],"intervention","mild traumatic brain injury","sleep quality","2026-06-17",{"date":160,"type":35},"2026-06-18",{"date":162,"type":35},"2025-09-10",{"date":164,"type":22},"2027-06-15",{"name":166,"class":42},"University of Colorado, Denver",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":17,"sex":174,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":43},"100540341","surgical-approach-to-uterine-septum-100540341","NCT06315582","Surgical Approach to Uterine Septum","Surgical Approach to Uterine Septum: A Randomized Controlled Trial","Inclusion criteria\n\n* Have a confirmed septum (\\>1.0 cm) confirmed with 3D imaging and\u002For MRI\n* 20-44 years old\n\nExclusion criteria\n\n* Known tubal disease\n* Bleeding diastasis\n* No blood thinners\n* No concurrent laparoscopy scheduled\n* Patient with confirmed fibroids over \\>1 cm FIGO (International Federation of Gynecology and Obstetrics) type 1","FEMALE","22 Years","44 Years",{"count":178,"type":22},40,[25],"The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.",[182,183,184,185,30],"Uterine Septum","Surgical Complication","Septum; Uterus","Treatment Side Effects","2026-05-28",{"date":188,"type":35},"2026-06-01",{"date":190,"type":35},"2024-03-11",{"date":192,"type":22},"2026-12",{"name":194,"class":42},"Northwestern University",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":203,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":43},"100563105","phase-1-venetoclax-in-combination-with-ivosidenib-and-azacitidine-for-newly-diagnosed-idh1-mutated-aml-100563105","NCT06611839","Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML","A Multicenter, Single-Arm Clinical Study of the Venetoclax, Ivosidenib, and Azacitidine Triple-Drug Regimen in the Treatment of Chemotherapy-eligible Adult Patients With IDH1-Mutated Acute Myeloid Leukemia.","IDH1-AML-2024","Inclusion Criteria:\n\n1. Patients who meet AML according to WHO (2022) or AML and MDS\u002FAML defined by ICC standards with IDH1 mutations detected by PCR or second-generation sequencing.\n2. Age ≥14 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :\n\n   1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);\n   2. AST and ALT≤ 2.5 times the upper limit of normal value (same age);\n   3. Blood creatinine \\< 2 times the upper limit of normal (same age);\n   4. Myocardial enzymes \\< 2 times the upper limit of normal (same age);\n   5. Left ventricular ejection fraction \\>50% by measure of echocardiogram (ECHO) Informed consent must be signed before the commencement of all specific study procedures, and is signed by the patient himself or his immediate family. Considering the patient\\'s condition, if the patient\\'s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\\'s immediate family.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are excluded from the study:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene\n3. Acute myeloid leukemia with BCR-ABL fusion gene\n4. Treated patients (but can receive hydroxyurea or cytarabine to lower tumor burden).\n5. Concurrent malignant tumors of other organs (those requiring treatment).\n6. Active heart disease, defined as one or more of the following:\n\n   1. A history of uncontrolled or symptomatic angina;\n   2. Myocardial infarction less than 6 months after enrollment;\n   3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;\n   4. Uncontrolled or symptomatic congestive heart failure (\\> NYHA level 2);\n7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).\n8. Those who were not considered suitable for inclusion by the researchers.","14 Years",{"count":205,"type":22},23,[207,57],"PHASE1","Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission rate (over 60%) in elderly unfit AML patients and markedly prolongs survival in those achieving complete remission. Isocitrate dehydrogenase (IDH) 1 and 2 are involved in the citric acid cycle. Approximately 20% of AML patients carry IDH1 or IDH2 mutations, which lead to the reduction of α-ketoglutarate to 2-hydroxyglutarate (2-HG). 2-HG can cause histone methylation and inhibit TET2 activity, resulting in DNA hypermethylation, thereby affecting gene expression and cell differentiation. IDH mutations are more common in elderly patients and are often associated with cytogenetic abnormalities; they may also co-occur with FLT3-ITD, NPM1, or DNMT3A mutations. Ivosidenib is an IDH1 inhibitor, and previous studies have confirmed its safety and efficacy in AML treatment. According to adult AML treatment guidelines, IDH-mutated patients eligible for intensive chemotherapy may receive IDH inhibitors during induction therapy. Based on the study by Montesinos et al. on the role of ivosidenib and azacitidine in IDH-mutated AML, for patients ineligible for intensive chemotherapy, a new treatment option has been added: IDH1-mutated AML patients may receive ivosidenib (500 mg, days 1-28) combined with azacitidine (75 mg\u002Fm²\u002Fday for 7 days) in 28-day cycles, or ivosidenib monotherapy. Recent studies have shown that a triple-drug regimen comprising ivosidenib, venetoclax, and azacitidine demonstrates excellent efficacy and safety. In chemotherapy-ineligible patients, the triple regimen achieved a composite complete remission rate (CRc) of 86% and an overall response rate (ORR) of 92%. At a median follow-up of 27.4 months, the 2-year overall survival (OS) was 72%, and the 2-year event-free survival (EFS) was 72%. Therefore, this study aims to conduct a multicenter, single-arm clinical trial to preliminarily evaluate the long-term efficacy of this combination in adult AML.",[210,211,30],"AML","IDH1 Mutation","2026-05-10",{"date":214,"type":35},"2026-05-13",{"date":216,"type":35},"2025-10-17",{"date":218,"type":22},"2028-10-01",{"name":220,"class":42},"Institute of Hematology & Blood Diseases Hospital, China",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":18,"minAge":229,"maxAge":52,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":111},"100472611","phase-2-modulating-exercise-dosage-to-improve-concussion-recovery-100472611","NCT05434130","Modulating Exercise Dosage to Improve Concussion Recovery","Modulating Exercise Dosage to Improve Concussion Recovery: A Randomized Clinical Trial","MEDIC","Inclusion Criteria:\n\n* 13-18 years of age\n* Post-Concussion Symptom Scale (PCSS) score \\>10 to ensure participants are not recovered by enrollment\n* Concussion diagnosis by a sports medicine physician\n\nExclusion Criteria:\n\n* Pre-existing neurological disorders\n* Exercise contraindications\n* Concussion \\\u003C6 months before enrollment (excluding the current injury)","13 Years",{"count":231,"type":22},216,[57],"Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.",[235,30,236,65,153],"Concussion, Brain","Aerobic Exercise",[155,156],"2026-05-04",{"date":240,"type":35},"2026-05-06",{"date":242,"type":35},"2022-08-05",{"date":244,"type":22},"2027-02-01",{"name":166,"class":42},{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":262,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":43},"100568506","a-clinical-study-of-personalized-self-dc-vaccine-targeting-neoantigen-in-treatment-of-advanced-solid-tumor-100568506","NCT06682117","A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor","Neo-DCV-001","Inclusion Criteria:\n\n1. 18-75 years.\n2. Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).\n3. HLA typing was HLA-A0201\u002F1101\u002F2402 (containing at least one of the typing, according to the central laboratory issued).\n4. Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).\n5. Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation \u002F ALK fusion positive), esophageal squamous cell carcinoma).\n6. Voluntary to participate in clinical research ; the person or legal guardian fully understands and is informed of this study and sign the informed consent; willing to follow and be able to complete all test procedures;\n7. ECOG score 0-1.\n8. Have a venous access to meet single collection or venous blood collection;\n9. Expected survival time ≥ 6 months.\n10. Subjects were willing to study the use of reliable contraceptive methods during treatment and within 3 months after the end of treatment, and women of childbearing age.\n11. Have adequent organ functions.\n12. Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs, immune checkpoint inhibitors, other clinical trial research drugs, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments received have passed the 4-week elution period, and the toxic and side effects returned to grade 1 or lower (except for alopecia, vitiligo and other tolerable events judged by researchers) ; 2) If undergoing major surgery within 3 weeks, the adverse reactions have returned to grade 1 or lower.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Patients with a history of severe immediate allergies to the cells and any drugs used in this study.\n3. Those with a history of organ transplantation.\n4. Known central nervous system metastasis.\n5. Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.\n6. Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.\n7. Suffering from severe liver and kidney function damage (liver, kidney treatment but still not controllable, biochemical indicators can not meet the inclusion criteria of NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poor drug control of hypertension ( systolic blood pressure more than 160mmHg and\u002For diastolic blood pressure more than 90mmHg), or with clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (6 months before signing informed consent) unstable angina, myocardial infarction (within 6 months before signing informed consent), unstable angina, New York Heart Association, or any circumstances which, in the opinion of the researcher, may increase the risk of the subject or interfere with the results of the test.\n8. Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.\n\n   Corticosteroids (prednisone or the same drug dose less than 10mg\u002Fday ) or other immunosuppressive agents were excluded.\n9. Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.\n10. The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.\n11. The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.\n12. There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.\n13. Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.","75 Years",{"count":255,"type":22},9,[25],"This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.",[30,259,260,261],"Neoantigen","Vaccine","Solid Tumor Cancer",[263,264,265],"advanced solid tumors","DC vaccine","neoantigen","2026-03-28",{"date":268,"type":35},"2026-04-02",{"date":270,"type":35},"2024-11-15",{"date":272,"type":22},"2026-12-30",{"name":274,"class":42},"Fudan University",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":285,"phases":4,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":295,"leadSponsor":297,"locationsCount":43},"100630436","treatment-response-in-patients-with-medication-overuse-headache-100630436","NCT07487649","Treatment Response in Patients With Medication-Overuse Headache","Factors Affecting Treatment Response in Patients With Medication-Overuse Headache Undergoing Greater Occipital Nerve Blockade","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Diagnosis of medication-overuse headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)\n* Diagnosis of medication-overuse headache associated with the use of triptans or nonsteroidal anti-inflammatory drugs\n* Previous diagnosis of chronic migraine or chronic tension-type headache according to the ICHD-3 criteria\n\nExclusion Criteria:\n\n* History of severe head or neck trauma or previous neurosurgical intervention\n* Presence of a severe psychiatric disorder (e.g., severe depression, schizophrenia)\n* History of infectious disease, chronic inflammatory disease, or malignancy\n* Previous diagnosis of secondary headache\n* History of substance abuse\n* Pregnancy or breastfeeding\n* History of an additional neurological disorder (e.g., cerebrovascular disease, multiple sclerosis)\n* Difficulty with cooperation\n* Presence of a concomitant systemic disease that may affect quality of life (e.g., congestive heart failure, chronic kidney disease, chronic liver disease, pulmonary disease, uncontrolled diabetes, or peripheral vascular disease)","65 Years",{"count":284,"type":22},70,"OBSERVATIONAL","The aim of this study to evaluate pre-injection patient-related factors that may influence treatment response in patients with medication-overuse headache who underwent ultrasound-guided greater occipital nerve block.",[288,30,289,290],"Medication-overuse Headache","Headache","Greater Occipital Nerve Block","2026-03-17",{"date":293,"type":35},"2026-03-23",{"date":291,"type":35},{"date":296,"type":22},"2026-05-30",{"name":298,"class":299},"Sultan 1. Murat State Hospital","OTHER_GOV",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":307,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":43},"100559370","phase-2-brentuximab-vedotin-for-newly-diagnosed-chl-in-chinese-caya-based-on-petct-assessment-100559370","NCT06563245","Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET\u002FCT Assessment","A Phase II\u002FIII Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET\u002FCT Assessment","Inclusion Criteria:\n\n* Ages \\>=2\\~\\\u003C35 years at the time of enrollment;\n* Patients with newly diagnosed, pathologically confirmed classical Hodgkin lymphoma (HL) by at least 2 tertiary referral centers for pathology;\n* Adequate organ function;\n* Patients and\u002For their parents or legal guardians sign a written informed consent;\n\nExclusion Criteria:\n\n* Patients with nodular lymphocyte-predominant HL;\n* Patients with an immunodeficiency that existed prior to diagnosis; such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible;Patients known to be positive for HIV are not eligible.\n* Patients who are pregnant; Lactating females who plan to breastfeed.\n* Patients who received systemic corticosteroids within 28 days of enrollment on this protocol","2 Years","35 Years",{"count":310,"type":22},96,[57,58],"Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.",[314,315,316,317,318,319,30,320,321],"Classical Hodgkin Lymphoma","Child","Adolescent","Young Adult","Metabolic Response","Survival","Brentuximab Vedotin","PET Scan",{"date":323,"type":35},"2026-03-19",{"date":325,"type":35},"2024-09-25",{"date":327,"type":22},"2039-11-15",{"name":329,"class":330},"Children's Cancer Group, China","NETWORK",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":174,"minAge":338,"maxAge":84,"enrollmentInfo":339,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100555336","phase-3-a-trial-of-chinese-traditional-medicine-combining-with-intradermal-acupuncture-for-treating-precocious-puberty-100555336","NCT06510764","A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty","A Randomized Controlled Trial of Ziyin-Xiehuo Chinese Medicine Herbs Combined With Intradermal Acupuncture for the Treatment of Girl's Idiopathic Precocious Puberty With Yin Deficiency and Fire Hyperactivity","Inclusion Criteria:\n\n* Girls are diagnosed as Idiopathic precocious puberty, and their age of onset ≤7.5years;\n* Tanner stages of breast in female patients ≤ Tanner III stage, diameters of mammillary nucleus ≤ 3cm; •B-type ultrasonography: the volume of uterus≥ 3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;\n* Bone age: compared the chronological age, the bone age is less than 1 year and the bone age \\\u003C10 years old;\n* No GnRH analogs or Sex hormones were administrated in the past; and All above are needed at the same time.\n\nExclusion Criteria:\n\n* Precocity caused by the central nervous system organic diseases;\n* Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;\n* Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;\n* Pseudo sexual precocity and partial precocious puberty.","4 Years",{"count":340,"type":22},170,[58],"A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.",[344,30,345,346],"Precocious Puberty","Alternative Medicine","Acupuncture","2026-03-13",{"date":349,"type":35},"2026-03-16",{"date":351,"type":35},"2024-09-15",{"date":353,"type":22},"2027-07-01",{"name":355,"class":42},"Children's Hospital of Fudan University",2,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":253,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":367,"conditions":368,"keywords":374,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":43},"100407991","early-phase-1-human-amniotic-derived-mesenchymal-stem-cell-therapy-for-calciphylaxis-100407991","NCT04592640","Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis","Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study","Inclusion Criteria:\n\n1. 18-75 years old.\n2. Clinical diagnosis of calciphylaxis, including patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).\n3. All subjects signed informed consent.\n\nExclusion criteria:\n\n1. Patients who refuse to sign informed consent.\n2. Patients with malignant tumors or severe psychiatric disorders, or an expected survival time of less than 6 months.\n3. Pregnant or lactating women of childbearing age.\n4. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.",{"count":255,"type":22},[366],"EARLY_PHASE1","Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells",[369,370,371,30,372,373],"Chronic Kidney Diseases","Calciphylaxis","Calcific Uremic Arteriolopathy","Safety","Efficacy",[369,370,371,375,376,372,373],"Human Amniotic-derived Mesenchymal Stem Cells","Rare disease (ORPHA280062)","2026-03-02",{"date":379,"type":35},"2026-03-04",{"date":381,"type":35},"2018-09-17",{"date":383,"type":22},"2028-09-17",{"name":385,"class":42},"The First Affiliated Hospital with Nanjing Medical University",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":43},"100615819","phase-2-anti-cd38-monoclonal-antibody-versus-rituximab-in-the-management-of-primary-immune-thrombocytopenia-itp-100615819","NCT07297563","Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)","A Randomized, Open-label Study To Compare The Efficacy And Safety Of Anti-CD38 Monoclonal Antibody Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients were required to have a response history (PLT≥50×10\\^9\u002FL) to standard first-line treatment of ITP (glucocorticoid and\u002For intravenous immunoglobulin).\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit, and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4 or 6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Subjects with a history of using CD20 monoclonal antibody or CD38 monoclonal antibody.\n* Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.\n* Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.\n* Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.\n* Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL.\n  5. IgG \\\u003C 500 mg\u002FdL.\n  6. lymphocyte count \\\u003C 500\u002Fmm3.\n  7. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":394,"type":22},160,[57],"This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[398,30],"Immune Thrombocytopenia","2026-02-09",{"date":401,"type":35},"2026-02-11",{"date":403,"type":35},"2026-01-20",{"date":405,"type":22},"2027-11",{"name":220,"class":42},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":43},"100610933","phase-2-rituximab-combining-anti-cd38-monoclonal-antibody-versus-rituximab-in-the-management-of-primary-immune-thrombocytopenia-itp-100610933","NCT07234019","Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)","A Randomized, Open-label Study To Compare The Efficacy And Safety Of Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 48 hours prior to the first dose of the study drug;The platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse).\n* Previous emergency treatment for ITP (e.g., methylprednisolone, platelet, gamma globulin infusion) must have been completed at least 2 weeks before the first dose.\n* Hepatic and renal function (e.g., alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatinine) \\\u003C1.5 times the upper limit of normal (ULN).\n* ECOG performance status score of ≤2.\n* Cardiac function: New York Heart Association (NYHA) class ≤2.\n* Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists, but the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug; Azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first dose; CD20 monoclonal antibody such as rituximab must have been stopped for more than 6 months; the interval between splenectomy and first administration need to be more than 6 months.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 90 days after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases.\n* HIV positive.\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive.\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc..\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled.\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis.\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past.\n* atients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up.\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared.\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.).\n* Patients with septicemia or other irregular severe bleeding.\n* Patients taking antiplatelet drugs at the same time.\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.\n* Subjects with a known allergy to medications were used in the trial or excipients.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":394,"type":22},[57],"This randomized, open-label study aim to compare the efficacy and safety of rituximab combining anti-CD38 monoclonal antibody with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[398,30],{"date":401,"type":35},{"date":420,"type":35},"2026-01-28",{"date":422,"type":22},"2028-11",{"name":220,"class":42},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":431,"maxAge":52,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":43},"100620793","phase-2-daratumumab-versus-rituximab-in-the-management-of-pediatric-primary-immune-thrombocytopenia-itp-100620793","NCT07362238","Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)","A Randomized, Open-label Study To Compare The Efficacy And Safety Of Daratumumab Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy","Inclusion Criteria:\n\n* Age ≥6，\\\u003C18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients were required to have a response history (PLT≥50×10\\^9\u002FL) to standard first-line treatment of ITP (glucocorticoid and\u002For intravenous immunoglobulin).\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit, and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.\n* Subjects and the legal guardian comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Subjects with a history of using CD20 monoclonal antibody or CD38 monoclonal antibody.\n* Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.\n* Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.\n* Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.\n* Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL.\n  5. IgG \\\u003C 500 mg\u002FdL.\n  6. lymphocyte count \\\u003C 500\u002Fmm3.\n  7. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.","6 Years",{"count":433,"type":22},122,[57],"This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[398,30],"2026-01-15",{"date":439,"type":35},"2026-01-23",{"date":441,"type":22},"2026-03",{"date":443,"type":22},"2028-03",{"name":220,"class":42},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":459,"leadSponsor":461,"locationsCount":43},"100620790","phase-2-anti-cd38-monoclonal-antibody-combined-with-rituximab-in-the-management-of-primary-immune-thrombocytopenia-itp-100620790","NCT07362199","Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)","A Single-arm, Open-label Phase II Clinical Study Evaluating the Efficacy of Rituximab Combined With Anti-CD38 Monoclonal Antibody in the Treatment of Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Subjects have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Subjects have failed at least one prior thrombopoietin receptor agonist therapy (such as rhTPO, eltrombopag, hetrombopag, etc.) in second-line treatment, as well as rituximab\u002Fanti-CD38 monoclonal antibody therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Alternatively, subjects have experienced treatment failure or post-splenectomy relapse following splenectomy.\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit, and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4 or 6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Subjects allergic to CD20 monoclonal antibody or CD38 monoclonal antibody.\n* Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.\n* Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.\n* Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.\n* Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have been treated with CD20 monoclonal antibodies (e.g., rituximab), CD38 monoclonal antibodies, cyclophosphamide, vindesine, or similar medications within 3 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL.\n  5. IgG \\\u003C 500 mg\u002FdL.\n  6. lymphocyte count \\\u003C 500\u002Fmm3.\n  7. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":453,"type":22},20,[57],"This single-arm, open-label phase II study aim to evaluate the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) combined with Rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[398,30],{"date":439,"type":35},{"date":441,"type":22},{"date":460,"type":22},"2027-03",{"name":220,"class":42},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":17,"sex":18,"minAge":431,"maxAge":203,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":43},"100617794","clinical-study-on-the-effectiveness-of-diverse-segments-defocus-optimization-in-spectacle-lenses-for-slowing-myopia-progression-100617794","NCT07323251","Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression","Inclusion Criteria:\n\n* Age 6-14 years\n* Myopic spherical equivalent refraction between -0.75D and -4.00D (inclusive of -0.75D and -4.00D, based on cycloplegic refraction)\n* Astigmatism ≤1.50D\n* Anisometropia ≤1.50D\n* Best-corrected visual acuity (BCVA) reaching 5.0 (0.00 LogMAR) or better in both eyes; monocular BCVA reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles\n* Absence of organic ocular diseases\n* No history of myopia control treatment within the past three months, including orthokeratology, progressive multifocal lenses, peripheral defocus spectacle lenses, bifocal spectacle lenses, defocus-designed soft hydrophilic contact lenses, other myopia control medications, or light-therapy devices\n* Voluntary participation in this clinical study and provision of signed informed consent\n\nExclusion Criteria:\n\n* History of ocular trauma or surgery\n* Systemic diseases affecting visual function\n* Inability to cooperate with examinations\n* Poor compliance\n* Inability to adhere to wearing requirements and follow-up visits during the trial period",{"count":469,"type":22},120,[25],"Clinical Trial\n\nThe goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are:\n\nDo D.S.D.O. lenses reduce the progression of myopia as measured by changes in cycloplegic refraction and axial length? What adverse events do participants experience when wearing D.S.D.O. lenses? Researchers will compare two optical designs of D.S.D.O. lenses (Intervention Group1: Design 1; Intervention Group2: Design 2) to determine their relative efficacy in controlling myopia progression.\n\nParticipants will:\n\nWear assigned D.S.D.O. lenses daily for 12 months (except during sleep or unavoidable situations).\n\nAttend clinic visits at baseline, 3, 6, 9, and 12 months for comprehensive eye examinations.\n\nMaintain a diary recording daily wear time, visual symptoms, and any adverse events.",[473,30,474,475,373],"Children With Myopia","Multizone Lens Design for Myopic Defocus","Visual Quality","2025-12-23",{"date":478,"type":35},"2026-01-07",{"date":480,"type":35},"2024-08-02",{"date":482,"type":22},"2026-09-30",{"name":484,"class":42},"Beijing Tongren Hospital",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":285,"phases":4,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":43},"100615676","micropulse-laser-in-treatment-of-initial-and-refractory-cases-of-center-involved-diabetic-macular-edema-100615676","NCT07295704","Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema","Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema","Inclusion Criteria:\n\n* Age ≥18 years.\n* Both sexes.\n* Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20\u002F400 or better, and center-involved DME \\[defined as a central macular thickness (CMT) of \\>250 but \\\u003C700µm measured by spectral-domain optical coherence tomography\\].\n* Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).\n\nExclusion Criteria:\n\n* Monocular eyes.\n* Chronic renal failure or renal transplant because of diabetic nephropathy.\n* Glycated hemoglobin (HbA1c) of more than 10%.\n* Vitreomacular traction syndrome.\n* Epiretinal membrane.\n* PRP within 4months before the treatment.\n* Intraocular surgery within 6months, including cataract or vitreoretinal operation.\n* Rubeosis iridis.\n* Severe glaucoma.\n* High-risk proliferative diabetic retinopathy.\n* Poor dilation.\n* Increased foveal avascular zone.\n* Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.",{"count":493,"type":22},50,"This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.",[496,30,497,498,499],"Micropulse Laser","Initial","Refractory","Center-Involved Diabetic Macular Edema","2025-12-06",{"date":502,"type":35},"2025-12-22",{"date":504,"type":35},"2025-10-15",{"date":506,"type":22},"2026-03-30",{"name":508,"class":330},"The General Authority for Teaching Hospitals and Institutes",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":431,"maxAge":516,"enrollmentInfo":517,"targetDuration":4,"studyType":23,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":43},"100529059","phase-2-anti-cd38-antibody-treating-pediatric-primary-immune-thrombocytopenia-itp-100529059","NCT06168851","Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Pediatric Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age 6 years and above, male or female\n* Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)\n* Diagnosis of ITP ≥3 months, and with a platelet count of \\\u003C30 X 10\\^9\u002FL measured within 2 days prior to inclusion\n* Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs.\n* The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration\n* Signed and dated written informed consent\n* With normal hepatic and renal functions\n* ECOG physical state score ≤ 2 points\n* Cardiac function of the New York Society of Cardiac Function ≤ 2\n* Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg\u002Fkg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\\>3 months；More than 6 months after splenectomy.\n\nMarch 26,2024 After approval by the Ethics Committee，age of subjects has been modified to 6 years and above upon enrollment. Approval Number: IIT2023072-EC-2.\n\nExclusion Criteria:\n\n* Allergy to daratumumab or its excipients, or prior treatment with daratumumab that was refractory or achieved a response lasting \\\u003C6 months；\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;\n* HIV positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);\n* Patients with septicemia or other irregular severe bleeding;\n* Patients taking antiplatelet drugs at the same time;\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.","17 Years",{"count":518,"type":22},60,[57],"To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and\u002For TPO-RA, or those in whom no other second-line treatment options are suitable.",[398,30],"2025-11-21",{"date":524,"type":35},"2025-11-28",{"date":526,"type":35},"2023-12-28",{"date":528,"type":22},"2030-12",{"name":220,"class":42},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":550,"leadSponsor":552,"locationsCount":43},"100605663","potassium-competitive-acid-blocker-versus-proton-pump-inhibitor-as-a-part-of-bismuth-based-quadruple-therapy-for-treatment-of-helicobacter-pylori-infection-100605663","NCT07165444","Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection","Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Both sexes.\n* Confirmed Helicobacter pylori infection by stool antigen (3rd-gen ELISA) or urea breath test (UBT).\n* No prior eradication therapy.\n\nExclusion Criteria:\n\n* Prior Helicobacter pylori treatment.\n* Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks.\n* Gastric surgery history.\n* Major organ failure.\n* Pregnancy or lactation.\n* Known allergy to study drugs.",{"count":538,"type":22},320,[25],"This study aims to compare the eradication rate, safety, and patient adherence between potassium-competitive acid blockers (P-CABs) and proton pump inhibitor-based bismuth quadruple therapy in patients with Helicobacter pylori infection.",[542,543,544,30,545],"Potassium-Competitive Acid Blocker","Proton Pump Inhibitor","Bismuth Based Quadruple Therapy","Helicobacter Pylori Infection","2025-09-11",{"date":548,"type":35},"2025-09-12",{"date":546,"type":35},{"date":551,"type":22},"2026-02-01",{"name":553,"class":42},"Tanta University",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":174,"minAge":4,"maxAge":4,"enrollmentInfo":561,"targetDuration":143,"studyType":285,"phases":4,"briefSummary":563,"conditions":564,"keywords":567,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":43},"100579922","study-of-molecular-characterisation-of-early-operable-primary-breast-cancer-in-pakistani-population-100579922","NCT06830590","Study of Molecular Characterisation of Early Operable Primary Breast Cancer in Pakistani Population","BrCa","Inclusion Criteria:\n\n* Women with confirmed diagnosis of breast cancer without history of taking neoadjuvant therapy Good quality tumour samples available for IHC\n\nExclusion Criteria:\n\n* patients received pre-operative chemotherapy or radiotherapy",{"count":562,"type":22},300,"This study is looking at the biological characteristics of early operable primary breast cancer in Pakistani Population by using IHC",[565,566,30],"Breast Cancer","Molecular Pathway Deregulation",[568,569],"Breast cancer","Molecular characterisation","2025-08-07",{"date":572,"type":35},"2025-08-13",{"date":574,"type":35},"2016-02-01",{"date":576,"type":22},"2025-12-31",{"name":578,"class":42},"Liaquat University of Medical & Health Sciences",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":431,"maxAge":52,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":43},"100580566","phase-2-anti-cd38-antibody-treating-children-with-primary-immune-thrombocytopenia-itp-100580566","NCT06838962","Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Children With Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age ≥6 years, ≤18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and\u002For intravenous human immunoglobulin) (PLT≥50×10\\^9\u002FL);\n* Platelet count \\\u003C30×10\\^9\u002FL within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an average platelet count \\\u003C30×10\\^9\u002FL and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. Only one concomitant medication was allowed at the time of enrollment, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the first dose of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4\u002F6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or kept a continuous response of less than 6 months.\n* All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.\n* Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage, intracranial hemorrhage, etc., or sepsis or other irregular bleeding within 12 months before the first medication.\n* Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is older) prior to the first dose.\n* Patients taking antiplatelet drugs within 3 weeks before the first dose.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive anti-CD20 monoclonal antibodies such as rituximab, or medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n* Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL; IgG \\\u003C 500 mg\u002FdL.\n  5. lymphocyte count \\\u003C 500\u002Fmm3.\n  6. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":587,"type":22},30,[57],"To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of primary immune thrombocytopenia in patients who have failed first-line treatment.",[398,30],"2025-07-31",{"date":593,"type":35},"2025-08-05",{"date":595,"type":35},"2024-08-01",{"date":597,"type":22},"2026-08",{"name":220,"class":42},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":43},"100575763","phase-1-a-clinical-study-of-nad-in-the-treatment-of-immune-thrombocytopenia-100575763","NCT06776510","A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Nicotinamide Adenine Dinucleotide in the Treatment of Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age 18 and above, male or female;\n* Conform to the diagnostic criteria of immune Thrombocytopenia (ITP) ≥3 months;\n* Failure to achieve response or relapse after corticosteroid therapy, and failure to achieve response or relapse after previous second-line treatments such as TPO\u002FTPORAs therapy, or are unable to afford the cost of the treatment;\n* The platelet count of \\\u003C30 X 10\\^9\u002FL measured within 2 days prior to inclusion (During the screening visit and\u002For before receiving the study drug, platelet counts must be less than 30×10\\^9\u002FL on at least two consecutive occasions, with a minimum interval of 1 day between the two tests.);\n* ECOG physical state score ≤ 2 points;\n* Subjects on stable dose maintenance therapy are allowed to be included (concomitant medications may include corticosteroids (≤0.5 mg\u002Fkg of prednisone or equivalent steroids) or TPO receptor agonists, etc.), but at the time of enrollment, only one concomitant medication with a stable dose is permitted. The concomitant medication must have been on a stable dose for at least 4 weeks prior to the first dose of the study drug;\n* For female patients of childbearing potential, a negative pregnancy test result is required. Both female patients of childbearing potential and male patients must use highly effective contraception during the study and for 4 months\u002F6 months after discontinuing treatment;\n* Signed and dated written informed consent\n\nExclusion Criteria:\n\n* Those who are allergic to Nicotinamide adenine dinucleotide or excipients, or who have previously received CD38 monoclonal antibody treatment with no efficacy.\n* Those with autoimmune hemolytic anemia, or various types of secondary and genetic thrombocytopenia, such as leukemia, lymphoma, multiple myeloma, aplastic anemia, myelodysplastic syndrome, Evans syndrome, common variable immunodeficiency, systemic lupus erythematosus, cirrhosis, antiphospholipid antibody syndrome, pseudo-thrombocytopenia, drug-induced thrombocytopenia (e.g., quinine, heparin, antimicrobial drugs, anticonvulsants, etc.).\n* A history of any thrombosis or embolism events within 12 months prior to the first dose, or the presence of extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, sepsis, or other irregular bleeding.\n* Participation in any other clinical trial involving investigational drugs (including vaccine studies) or exposure to other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.\n* Use of anticoagulants or any drugs with antiplatelet effects (e.g., aspirin) within 2 weeks prior to the first dose.\n* Receiving emergency treatment for ITP within 2 weeks prior to the first dose (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin, or TPO receptor agonist treatment).\n* Receiving azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, or similar drugs within 4 weeks prior to the first dose; receiving CD20 monoclonal antibodies such as rituximab, cyclophosphamide, vincristine, or similar drugs within 3 months prior to the first dose.\n* Splenectomy within 6 months prior to the first dose.\n* Receiving a live vaccine within 4 weeks prior to the first dose, or planning to receive any live vaccine during the study period.\n* A history of undergoing allogeneic stem cell transplantation or organ transplantation.\n* A history of clinically significant diseases that, in the investigator's opinion, may pose a risk to the subject's safety or affect the assessment of safety or efficacy during the study if the disease\u002Fcondition worsens.\n* Subjects who have had malignant tumors within the past 5 years prior to screening (excluding completely cured carcinoma in situ of the cervix and non-metastatic squamous cell carcinoma or basal cell carcinoma of the skin).\n* Exhibiting clinically significant laboratory abnormalities at screening: a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ the upper limit of normal (ULN); b) Total bilirubin ≥ 1.2 times ULN. ;c) Creatinine or blood urea nitrogen (BUN) ≥ ULN.\n* Positive for HIV antibodies or syphilis antibodies.\n* Positive for hepatitis B surface antigen (HBsAg) at screening, or positive for hepatitis B core antibody with a positive HBV-DNA result by polymerase chain reaction (PCR) testing, or positive for hepatitis C virus (HCV) antibodies.\n* Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study; and men whose partners are planning to become pregnant during the study.\n* Subjects with mental disorders who are unable to provide informed consent or participate in the trial and follow-up properly.\n* Subjects with unresolved toxicity symptoms caused by prior treatments before participating in the trial.\n* Any other conditions deemed unsuitable for participation in this study as assessed by the investigator.",{"count":453,"type":22},[207,57],"To evaluate the safety and efficacy of nicotinamide adenine dinucleotide in the treatment of immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and\u002For TPO-RA.",[398,30],{"date":593,"type":35},{"date":612,"type":35},"2025-01-15",{"date":614,"type":22},"2026-03-01",{"name":220,"class":42},{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":23,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":633,"locationsCount":43},"100597800","phase-2-anti-cd38-antibody-treating-elderly-patients-with-primary-immune-thrombocytopenia-itp-100597800","NCT07063199","Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)","A Single-arm, Open-label Clinical Study Evaluating the Safety and Efficacy of Daratumumab in Elderly Patients With Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n* Age ≥60 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Patients have failed glucocorticoid therapy and at least one standard second-line therapy. (either due to inefficacy, efficacy could not be maintained, or relapse). Patients should have a history of response to previous ITP standard first-line therapy (glucocorticoids and\u002For intravenous human immunoglobulin) (PLT≥50×10\\^9\u002FL);\n* Platelet count \\\u003C30×10\\^9\u002FL within 24 hours before the first administration of the study drug; During the screening period, platelet counts were measured at least 2 times (at least 1 week apart), with an average platelet count \\\u003C30×10\\^9\u002FL and no platelet count \\> 35×10\\^9\u002FL.\n* ECOG performance status score of ≤2.\n* Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists. Only one concomitant medication was allowed at the time of enrollment, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the first dose of the study drug.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 4\u002F6 months after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Those who are allergic to anti-CD38 monoclonal antibody or excipients, or who have received anti-CD38 monoclonal antibody in the past and failed or kept a continuous response of less than 6 months.\n* All kinds of secondary thrombocytopenia or autoimmune hemolytic anemia.\n* Any history of thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, massive upper digestive tract hemorrhage, intracranial hemorrhage, etc., or sepsis or other irregular bleeding within 12 months before the first medication.\n* Participated in or was exposed to any other investigational drug study (including vaccine study) during the 4 weeks or 5 half-lives (whichever is older) prior to the first dose.\n* Subjects taking antiplatelet drugs within 3 weeks before the first dose.\n* Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.\n* Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive anti-CD20 monoclonal antibodies such as rituximab, or medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.\n* Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.\n* Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.\n\nSubjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).\n\n* Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.\n* Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;\n* Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.\n* Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).\n* Significant laboratory abnormalities during screening included:\n\n  1. Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).\n  2. Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).\n  3. absolute neutrophil count \\\u003C 1500\u002Fmm3.\n  4. hemoglobin \\\u003C 9g\u002FdL; IgG \\\u003C 500 mg\u002FdL.\n  5. lymphocyte count \\\u003C 500\u002Fmm3.\n  6. Creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (i.e., CrCl ≥30 mL\u002Fmin is allowed)\n* Positive for HIV antibodies or syphilis antibodies.\n* Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.\n* Pregnant or lactating women, or those intending to conceive or breastfeed during the study; and male partners intending to induce pregnancy during the study.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.",{"count":587,"type":22},[57],"To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of elderly patients with primary immune thrombocytopenia in patients who have failed multiple treatment.",[398,30],"2025-07-03",{"date":629,"type":35},"2025-07-14",{"date":631,"type":22},"2025-08",{"date":597,"type":22},{"name":220,"class":42}]