[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kyushu University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,66,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100652537","phase-1-safety-evaluation-study-of-pitavastatin-plga-nano-particle-for-retinitis-pigmentosa-100652537",false,"NCT07774975","Safety Evaluation Study of Pitavastatin PLGA Nano-particle for Retinitis Pigmentosa","Investigator-initiated Phase 1 Clinical Trial to Evaluate the Safety of Pitavastatin PLGA Nano-particle in Patients With Retinitis Pigmentosa","RP CLARITI","Inclusion Criteria:\n\n1. Patients diagnosed with typical retinitis pigmentosa by two ophthalmologists according to the Clinical Practice Guidelines for Retinitis Pigmentosa (genomic diagnosis will not be performed).\n2. Patients aged 18 years or older and 70 years or younger at the time of informed consent.\n3. \\* Patients with a mean retinal sensitivity of 10 dB or higher within the central 4 degrees (12 points) of the Humphrey 10-2 visual field.\n4. \\* Patients whose difference in mean retinal sensitivity (MD value) between two Humphrey 10-2 examinations at screening is within 3 dB. If the criteria are not met in the second examination, a third measurement will be performed within 14 days of the second examination, and the difference between the third measurement and the first or second measurement must be within 3 dB.\n5. \\* Patients with a foveal retinal thickness of 250 micrometer or less as measured by optical coherence tomography.\n\n   \\*At least one eye must meet criteria 3, 4, and 5.\n6. Female patients of childbearing potential who agree to use appropriate contraception from the time of informed consent until 180 days after the last dose of the investigational product.\n7. Male patients who agree to use appropriate contraception for 3 days from each administration of the investigational product.\n8. Patients who can provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients currently taking statins for hyperlipidemia.\n2. Patients who have received helenien, unoprostone, or calcium channel blockers for the treatment of eye diseases within 30 days prior to informed consent.\n3. Patients scheduled for ophthalmic surgery during the study period.\n4. Patients with concomitant glaucoma or ocular hypertension.\n5. Patients with concomitant uveitis or optic neuritis.\n6. Patients with retinal lesions not attributable to retinitis pigmentosa (e.g., fundus hemorrhage, retinal edema, proliferative tissue, etc.) observed on fundus examination.\n7. Patients with a history of hypersensitivity or severe adverse reactions to pitavastatin calcium or any component of the investigational product.\n8. Patients with severe allergies or a history thereof.\n9. Patients with severe renal impairment.\n10. Patients with severe cardiac dysfunction or heart failure.\n11. Patients with severe hepatic impairment.\n12. Patients with biliary obstruction.\n13. Patients with active inflammatory diseases or infections (e.g., active collagen disease, rheumatoid arthritis, ulcerative colitis, sepsis, etc.).\n14. Patients with a history of cerebral hemorrhage, cerebral infarction, or ischemic heart disease within 6 months prior to informed consent.\n15. Patients with hematological disorders (e.g., severe anemia, leukemia, aplastic anemia, etc.).\n16. Patients with alcohol dependence, drug dependence, or mental disorders that may interfere with study participation.\n17. Patients with concomitant malignant tumors or who have received treatment for malignant tumors within the past 3 years.\n18. Patients currently receiving cyclosporine.\n19. Patients currently receiving fibrate drugs (e.g., clofibrate, fenofibrate, bezafibrate, etc.) who cannot discontinue fibrate drugs from 3 days prior to the start of investigational product administration.\n20. Patients currently receiving nicotinic acid, erythromycin, or rifampicin who cannot discontinue these drugs from 3 days prior to the start of investigational product administration.\n21. Patients currently participating in other clinical trials or studies.\n22. Pregnant women, women suspected of being pregnant, or lactating women.\n23. Any other patient judged unsuitable by the principal investigator or sub-investigator.","ALL","18 Years","70 Years",{"count":21,"type":22},21,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Retinitis pigmentosa (RP) is a rare inherited retinal degenerative disease that causes progressive visual field loss and vision impairment, often leading to blindness. Currently, there are limited treatment options capable of slowing disease progression for the majority of patients with RP. Preclinical studies have suggested that retinal inflammation, particularly the activity of inflammatory monocytes and macrophages, may contribute to photoreceptor degeneration. ULREA-PVS-NP is a novel intravenous formulation consisting of pitavastatin encapsulated in poly(lactic-co-glycolic acid) (PLGA) nanoparticles, developed to target inflammatory pathways associated with retinal degeneration. Preclinical studies demonstrated suppression of inflammatory monocyte\u002Fmacrophage activity and preservation of photoreceptors in animal models of RP.\n\nThis is a single-center, open-label, investigator-initiated Phase 1 study designed to evaluate the safety of intravenous ULREA-PVS-NP in adults with RP. The study consists of two parts. In Part 1, participants will receive a single intravenous infusion of ULREA-PVS-NP at escalating dose levels (2 mg, 4 mg, or 8 mg) to evaluate safety and tolerability. Following review of safety data, Part 2 will evaluate repeated administration of the highest dose considered safe in Part 1, given once every four weeks for a total of three administrations.\n\nThe primary objective is to evaluate the safety of ULREA-PVS-NP by assessing the incidence of adverse events. Secondary objectives include characterization of pharmacokinetic profiles, evaluation of changes in clinical laboratory tests and vital signs, and exploratory assessment of ophthalmologic outcomes and inflammatory biomarkers.",[28],"Retinitis Pigmentosa (RP)","NOT_YET_RECRUITING","2026-08-15",{"date":32,"type":33},"2026-08-19","ACTUAL",{"date":35,"type":22},"2026-09-15",{"date":37,"type":22},"2028-03-31",{"name":39,"class":40},"Kyushu University","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100485982","phase-1-clinical-trial-of-gaia-102-for-refractoryrelapse-neuroblastomas-and-other-malignant-pediatric-solid-tumors-100485982","NCT05608148","Clinical Trial of GAIA-102 for Refractory\u002FRelapse Neuroblastomas and Other Malignant Pediatric Solid Tumors","Inclusion Criteria:\n\n1. Patients who have been confirmed to have the following malignant tumor by histological examination\n\n   * cohort A : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) .\n   * cohort B : neuroblastoma.\n   * cohort C \\& D : neuroblastoma and other malignant solid tumors, rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma.\n2. Undergoing the following treatment.\n\n   * cohort A \\& B : Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.\n   * cohort C \\& D : Patients with neuroblastoma who have completed the dinutuximab regimen and still have residual tumor. Patients with rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.\n3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.\n4. Patients aged from 1years to 24 years at the time of obtaining consent.\n5. Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent.\n\nExclusion Criteria:\n\n1. Patients with brain metastases.\n2. Patients diagnosed with cancerous meningitis\n3. Patients who received allogeneic hematopoietic stem cell transplant.\n4. Patients with active autoimmune disease.","1 Year","24 Years",{"count":50,"type":22},61,[25],"Cohort A(GAIA-102 alone):\n\nConfirm the safety of GAIA-102 alone for refractory\u002Frelapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for Phase II.\n\nCohort B(GAIA-102 with Dinutuximab):\n\nConfirm the safety of GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination for refractory\u002Frelapse neuroblastoma and decide recommended dose for Phase II.\n\nCohort C(GAIA-102 with Nivolumab):Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab.\n\nCohort D(GAIA-102 with Nivolumab, Teceleukin):\n\nConfirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab, Teceleukin.",[54,55],"Refractory\u002FRelapse Neuroblastoma","Pediatric Solid Tumors","RECRUITING","2026-08-04",{"date":59,"type":33},"2026-08-07",{"date":61,"type":33},"2022-10-26",{"date":63,"type":22},"2027-08-25",{"name":39,"class":40},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100649808","phase-1-safety-and-efficacy-study-of-sivelestat-in-neuromyelitis-optica-spectrum-disorder-100649808","NCT07738952","Safety and Efficacy Study of Sivelestat in Neuromyelitis Optica Spectrum Disorder","A Phase I\u002FIIa Investigator-Initiated Clinical Trial to Evaluate the Safety and Efficacy of Sivelestat in Patients With Acute Relapse of Neuromyelitis Optica Spectrum Disorder","SIVAR-NMOSD","Inclusion Criteria:\n\n1. Patients diagnosed with anti-AQP4 antibody-positive NMOSD according to the international diagnostic criteria for NMOSD (Wingerchuk, Neurology 2015).\n2. Patients experiencing a relapse including any of the following, with the relapse occurring within 14 days of obtaining consent:\n\n   i. Unilateral or bilateral optic neuritis ii. Myelitis\n3. Patients whose FS domain has worsened by at least 1 point due to relapse.\n4. Patients with one or more relapse lesions identified on MRI (however, if the relapse is considered to have occurred in the same location as an existing MRI lesion neurologically, identification of a new relapse lesion is not required).\n5. Patients aged 18 years or older at the time of obtaining consent.\n6. Female patients of childbearing potential who agree to use appropriate contraception from the time of obtaining consent until 180 days after the end of investigational product administration.\n7. Male patients who agree to use appropriate contraception until 90 days after the end of investigational product administration.\n8. Patients who can provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with multi-organ dysfunction involving 4 or more organs.\n2. Patients with severe chronic respiratory disease.\n3. Patients with autoimmune diseases other than NMOSD that are expected to require additional treatment during the study period.\n4. Patients with active systemic bacterial, viral, or fungal infections.\n5. Patients who have received either or both of the following prior treatments after an NMOSD relapse:\n\n   i. Two or more courses of steroid pulse therapy ii. Plasmapheresis iii. High-dose immunoglobulin therapy\n6. Patients with severe hepatic dysfunction.\n7. Patients with alcohol dependence, drug dependence, or psychiatric disorders that would interfere with study participation.\n8. Patients who have received other investigational drugs within 3 months prior to obtaining consent.\n9. Pregnant women, women suspected of being pregnant, or breastfeeding women.\n10. Patients with allergies to the investigational product or concomitant medications.\n11. Patients with severe allergies or a history of severe allergies.\n12. Patients with suicidal tendencies meeting any of the following criteria:\n\n    i. Within 1 month prior to the screening assessment, there was suicidal behavior or ideation corresponding to \"Yes\" for Item 4 (Active suicidal ideation -some intent to act, but no specific plan) or Item 5 (Active suicidal ideation -specific plan and intent) of the Columbia-Suicide Severity Rating Scale (C-SSRS). (For subjects who only met Items 1-3, inclusion may be permitted at the discretion of the principal investigator or sub-investigator.) ii. Any suicidal behavior based on Item 6 of the C-SSRS occurred within the past 3 months.\n13. Other patients judged inappropriate by the principal investigator or sub-investigator.",{"count":75,"type":22},7,[25,77],"PHASE2","The primary objective of this study is to evaluate the safety and tolerability of sivelestat sodium hydrate administered in combination with standard steroid pulse therapy in patients experiencing an acute NMOSD attack. Safety assessments will include adverse events, laboratory parameters, vital signs, and other clinically relevant findings. In addition, the study will explore whether the addition of sivelestat sodium hydrate to standard steroid pulse therapy improves neurological outcomes in patients with acute NMOSD.\n\nParticipants will receive intravenous sivelestat sodium hydrate at a dose of 4.8 mg\u002Fkg\u002Fday administered as a continuous infusion (0.2 mg\u002Fkg\u002Fhour) for 5 consecutive days, receive steroid pulse therapy according to the study protocol, and be followed for 28 days after treatment initiation for safety and efficacy evaluations.",[80],"Neuromyelitis Optica Spectrum Disorder Attack",[82,83],"NMOSD","Sivelestat","2026-07-27",{"date":86,"type":33},"2026-07-31",{"date":88,"type":22},"2026-08-17",{"date":90,"type":22},"2028-05-31",{"name":39,"class":40},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":65},"100472943","phase-1-gaia-102-intraperitoneal-administration-in-patients-with-advanced-gastrointestinal-cancer-of-microsatellite-stable-with-malignant-ascites-100472943","NCT05438459","GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites","Clinical Trial of Repeated Intraperitoneal Administration of GAIA-102 in Patients With Advanced Gastrointestinal Cancer (Gastric Cancer \u002F Pancreatic Cancer) of Microsatellite Stable (MSS) With Malignant Ascites (Phase I \u002F II Investigator-initiated Clinical Trial) (GAIA-102-PD Clinical Trial)","Inclusion Criteria:\n\n1. Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.\n2. Phase I:\n\n   Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.\n\n   Phase II:\n\n   Patients with gastric cancer who have received 2 or more prior chemotherapy regimens, including at least 1 regimen containing an immune checkpoint inhibitor, and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 1 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.\n3. Abdominal port placement is possible\n4. No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)\n5. Diagnosed gastric adenocarcinoma or pancreatic cancer with by histological or cytological examination\n6. The patient has been confirmed to be \"negative (not MSS = MSI-high)\" by microsatellite instability (MSI) testing, or \"proficient mismatch repair (pMMR)\" by mismatch repair protein immunohistochemistry testing\n7. The Eastern Cooperative Oncology Group (ECOG) performance status(PS) at the time of informed consent meets the following conditions.\n\n   * Phase I ：0-2\n   * Phase II ：0-1\n8. Patient aged 20years or older\n9. Adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function:\n\n   * Neutrophil ≧1,500\u002Fmm3\n   * hemoglobin ≧8.0 g\u002FdL\n   * Platelet ≧75,000\u002Fmm3\n   * PT-INR≦ 1.5\n   * AST, ALT≦ 3 times the upper limit of reference value\n   * T-Bil≦ 2 times the upper limit of reference value (T-Bil ≦ 3.0mg\u002FdL , when drainage for obstructive jaundice)\n   * eGFR ≧30mL\u002Fmin\u002F1.73m2\n10. Expected to survive for 3 months or more at the enrollment\n11. Written informed consent\n\nExclusion Criteria:\n\n1. Untreated cranial metastases.\n2. Diagnosed with meningeal carcinomatosis\n3. Received allogeneic hematopoietic stem cell transplantation\n4. Participated in other clinical trials \u002F clinical trials within 30 days prior to obtaining written consent and used or had used the investigational product or investigational equipment.\n5. Existence or suspected active autoimmune disease\n6. Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg \u002F day in terms of prednisolone or other immunosuppressants within 14 days prior to investigational product administration\n7. Symptomatic interstitial pneumonia, or even if it is not symptomatic, it may interfere with diagnostic imaging in detecting new pneumonitis caused by the investigational product used in the clinical trial.\n8. Have active double cancer and need treatment for the double cancer\n9. Requires treatment as shown in \"Unacceptable Combination \u002F Supportive Therapy\" during the clinical trial period\n10. Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment\n11. Have one of the following complications\n\n    * Complication of cerebrovascular disorder with symptoms or history within 6 months before the enrollment\n    * Active gastrointestinal perforation, fistula, diverticulitis\n    * Symptomatic congestive heart failure\n    * Bleeding tendency\n    * Presence of blood clots that may cause embolism on the image\n    * Unhealed fractures (excluding compression fractures associated with osteoporosis) or severe wounds requiring medical treatment\n    * Uncontrollable digestive ulcer\n    * Active infectious diseases requiring intravenous administration of antibiotics, antifungal agents or antiviral agents\n    * HIV antibody positive\n12. At the time of the enrollment, the period from the following prior treatment or the end of treatment has not passed.\n\n    * Surgery (including exploratory laparotomy \u002F examination laparoscope): 2 weeks\n    * Palliative radiotherapy: 1 week\n    * Thoracic drainage: 1 week\n    * Pretreatment antineoplastic (from the last administration): 3 weeks\n    * Biopsy with incision, thoracic biopsy, treatment for trauma (excluding patients without wound healing), etc : 2 weeks\n13. Scheduled thoracotomy or abdominal surgery during the clinical trial period\n14. It is judged that it is difficult to enroll in this study due to clinically significant mental illness.\n15. Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.\n16. Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)\n17. Difficult to participate in the trial by the investigator","20 Years",{"count":101,"type":22},130,[25,77],"Phase I Part :\n\nConfirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part.\n\nPhase II Part :\n\nResearch the efficacy and safety of as a monotherapy or GAIA-102 and pembrolizumab for advanced gastrointestinal cancer of microsatellite stable with malignant ascites at the recommended dose of GAIA-102 decided in the Phase I part.",[105,106],"Gastric Cancer","Pancreatic Cancer","2025-11-14",{"date":109,"type":33},"2025-11-18",{"date":111,"type":33},"2022-06-08",{"date":113,"type":22},"2029-03-31",{"name":39,"class":40},""]