[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hepaititis-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hepaititis-b":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100649928","phase-1-act201-injection-in-healthy-participants-and-participants-with-chronic-hepatitis-b-chb-100649928",false,"NCT07741461","ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B (CHB)","A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, Drug Concentration-QTc Relationship, and Immunogenicity Profiles of Single and Multiple Doses of ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B","Inclusion Criteria:\n\nPart 1:\n\n* Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial and provide written informed consent;\n* Aged between 18 and 55 years old (inclusive) at the time of informed consent, male or female;\n* Body mass index meets specified criteria;\n* Physical examination, vital signs, laboratory tests, electrocardiogram and imaging examinations at screening are normal or abnormalities are considered clinically insignificant;\n* Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation.\n\nPart 2:\n\n* Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial and provide written informed consent;\n* Aged between 18 and 65 years old (inclusive) at the time of informed consent, male or female;\n* Body mass index meets specified criteria;\n* HBsAg-positive or HBV DNA-positive for at least 6 months, or previous liver biopsy confirming chronic HBV infection;\n* Receiving stable nucleos(t)ide analogue (NA) therapy at screening, with no planned changes to NA regimen during the trial;\n* Serum ALT ≤ 2 × ULN at screening; HBeAg, HBV DNA and HBsAg levels meet protocol-specified criteria;\n* Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation.\n\nExclusion Criteria:\n\nPart 1:\n\n* Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged clinically significant by the Investigator).\n* History of clinically significant diseases involving cardiovascular, hematologic and lymphatic, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy).\n* Vital signs or laboratory examinations at screening meet the exclusion cut-off values specified in the protocol.\n* Use of any prescription drugs, over-the-counter medications, vitamin products or herbal medicines within 2 weeks prior to the first dose (topical medications with local effects are excluded).\n* Positive HBsAg, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.\n* QTcF interval (QT corrected by Fridericia's formula) \\> 450 ms at screening.\n* Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening.\n* History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening.\n* History of alcohol abuse within 6 months before screening (14 alcohol units per week: 1 unit = 285 mL beer with \\~3.5% alcohol, or 25 mL spirits with \\~40% alcohol, or 100 mL wine with \\~10% alcohol), or positive breath alcohol test at screening.\n* Vaccination administered within 1 month before screening, or planned vaccination during the trial period.\n* Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period.\n* Female participants who are breastfeeding or have a positive serum pregnancy test at screening.\n* Participation in any clinical trial with an investigational medicinal product\u002Finvestigational device within 3 months before screening or within 5 half-lives (whichever is longer).\n* Any other condition deemed unsuitable for trial participation by the Investigator.\n\nPart 2：\n\n* Major trauma or major surgery within 3 months before screening; or planned surgery during the trial period that may impair trial compliance or safety assessment as assessed by the Investigator.\n* Uncontrolled and clinically significant abnormalities other than chronic HBV infection, such as acute cerebrovascular disease, severe or unstable cardiac disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled dyslipidemia, etc.\n* History of other clinically significant liver diseases.\n* History of liver cirrhosis or progressive liver fibrosis; or liver stiffness measurement (LSM) ≥ 8.5 kPa at screening.\n* Alpha-fetoprotein \\> 50 ng\u002FmL, or imaging suggestive of possible malignant hepatic lesions.\n* Past or current manifestations of hepatic decompensation.\n* History of extrahepatic diseases potentially related to HBV immune status.\n* History of vasculitis; or signs\u002Fsymptoms suggestive of underlying vasculitis; or past\u002Fcurrent other diseases potentially associated with vasculitic disorders.\n* Active infection requiring systemic antiviral or antibacterial treatment at screening, excluding HBV infection.\n* History of malignant tumors within 5 years before screening, except for specific curable cancers resected surgically.\n* Prior solid organ or bone marrow transplantation.\n* Use of systemic immunosuppressants within 3 months before the first dose of investigational product \\[short-term (≤7 days) glucocorticoids for prophylaxis or treatment of non-autoimmune diseases excluded\\]; use of immunomodulators or cytotoxic agents within 6 months before the first dose of investigational product.\n* Receipt of any oligonucleotide or small interfering RNA (siRNA) therapy within 12 months before the first dose of investigational product.\n* Coexisting indication for anticoagulant therapy or anticipated requirement for anticoagulation during the trial.\n* Any of the following laboratory results at screening, or other clinically significant abnormalities rendering the participant unsuitable for trial participation:\n\nPlatelet count \\\u003C 125 × 10\\^9\u002FL Absolute neutrophil count \\\u003C 1.5 × 10\\^9\u002FL Hemoglobin \\\u003C 100 g\u002FL Total bilirubin \\> 1.25 × ULN Serum albumin \\\u003C 35 g\u002FL Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2 (calculated using the CKD-EPI formula) Prothrombin time international normalized ratio (INR) \\> 1.25 Positive hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody\n\n* QTcF interval (QT corrected by Fridericia's formula) \\> 450 ms at screening, or other clinically significant electrocardiogram abnormalities identified at screening.\n* Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged clinically significant by the Investigator).\n* Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening.\n* History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening.\n* History of alcohol abuse within 6 months before screening, or positive breath alcohol test at screening.\n* Vaccination administered within 1 month before screening, or planned vaccination during the trial period.\n* Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period.\n* Female participants who are breastfeeding or have a positive serum pregnancy test at screening.\n* Participation in any clinical trial with an investigational medicinal product\u002Finvestigational device within 3 months before screening or within 5 half-lives (whichever is longer).\n* Any other condition deemed unsuitable for trial participation by the Investigator.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial consisting of two parts. Part 1 includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts conducted in healthy participants. Part 2 is a multiple ascending dose (MAD) trial enrolling HBeAg-negative chronic hepatitis B (CHB) participants with suppressed HBV DNA under stable nucleos(t)ide analog (NA) therapy.",[28],"Chronic Hepaititis B",[28,30],"ACT201 Injection","RECRUITING","2026-08-14",{"date":34,"type":35},"2026-08-17","ACTUAL",{"date":37,"type":35},"2026-08-06",{"date":39,"type":22},"2027-04",{"name":41,"class":42},"Xiamen Amoytop Biotech Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100608333","phase-1-a-phase-12-open-label-single-and-multiple-ascending-dose-study-of-crma-1001-in-adults-with-chronic-hepatitis-b-100608333","NCT07200193","A Phase 1\u002F2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B","A Multi-Center, Phase 1\u002F2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B","Inclusion Criteria:\n\n* Male\u002FFemale, weight 45-150 kg, age 18-64, inclusive\n* Diagnosed with Chronic Hepatitis B\n* On oral antiviral therapy\n* ALT and AST \\\u003C= 1.5 x ULN\n* Total bilirubin \\\u003C= ULN\n\nExclusion Criteria:\n\n* Significant hepatic fibrosis or cirrhosis\n* Current or prior liver disease other than HBV\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply","64 Years",{"count":53,"type":22},66,[25,55],"PHASE2","This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.",[28],[59,60,61,62,63,64],"CHB","Chronic hepatitis B","Chronic HBV","Chronic Hep B","Chronic hepatitis","HBV","2026-06-12",{"date":67,"type":35},"2026-06-15",{"date":69,"type":35},"2025-12-22",{"date":71,"type":22},"2032-12-31",{"name":73,"class":42},"nChroma Bio",4,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"100618214","early-phase-1-immunomodulatory-therapy-and-predictors-of-clinical-cure-in-chronic-hepatitis-b-100618214","NCT07328711","Immunomodulatory Therapy and Predictors of Clinical Cure in Chronic Hepatitis B","Study on Novel Immunomodulatory Therapeutic Regimens for Clinical Cure of Chronic Hepatitis B and Efficacy Prediction","Inclusion Criteria:\n\n1. Aged 18 to 60 years (inclusive).\n2. Documented HBsAg and\u002For HBV DNA positivity for over 6 months.\n3. Achieved HBsAg seroclearance (\\\u003C0.05 IU\u002FmL) following a PegIFNα-based treatment regimen.\n4. HBeAg negative and HBV DNA \\\u003C10 IU\u002FmL.\n5. Good compliance and willingness to voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Current decompensated cirrhosis or a history of decompensated cirrhosis.\n2. Individuals with spontaneous or Nucleos(t)ide analogue-induced HBsAg seroclearance.\n3. Coinfection with other viruses, such as hepatitis A, C, D, E viruses, or human immunodeficiency virus (HIV).\n4. Severe concurrent physical or mental illnesses other than hepatitis B, including uncontrolled primary renal, cardiac, pulmonary, vascular, neurological, digestive, or severe metabolic diseases (e.g., uncontrolled hyperthyroidism, severe diabetic complications, adrenal disorders), immunodeficiency diseases, or severe infections; active or suspected malignancy, or a history of malignancy.\n5. Use of corticosteroids, immunosuppressants, or chemotherapeutic agents within the 6 months prior to enrollment or at present.\n6. Concurrent other liver diseases such as alcoholic liver disease or autoimmune liver disease.\n7. Body Mass Index (BMI) \\> 28 kg\u002Fm².\n8. Any other condition considered by the investigator to potentially compromise patient compliance or otherwise make the patient unsuitable for participation in the study.","60 Years",{"count":84,"type":22},132,[86],"EARLY_PHASE1","Achieving clinical cure, defined as hepatitis B surface antigen (HBsAg) seroclearance, represents a major research focus and an ideal therapeutic goal for chronic hepatitis B (CHB). A significant challenge in CHB management lies in promoting clinical cure, reducing relapse, and progressing towards complete cure. Studies have found that in patients who achieve HBsAg seroclearance following peginterferon alfa (PegIFNα) therapy, the seroconversion of anti-HBs and its attainment to a certain level are crucial for minimizing relapse. Strategies to promote anti-HBs seroconversion include active immunization (hepatitis B vaccine) and passive immunization (hepatitis B immunoglobulin, HBIG). Existing literature and preliminary findings from our team suggest that hepatitis B vaccine alone is ineffective in preventing relapse after clinical cure. This project proposes a multicenter, prospective, randomized controlled study. It will enroll CHB patients who have achieved HBsAg seroclearance with PegIFNα-based therapy, with the primary endpoint being the sustained HBsAg seroclearance rate at 48 weeks. The study will compare the efficacy between a group receiving HBIG immunization and a non-immunization control group. We anticipate that passive immunization with HBIG following HBsAg seroclearance will lead to a sustained clinical cure in CHB patients. This study aims to explore novel approaches for reducing relapse after clinical cure and pursuing complete cure, identify relevant biomarkers, and establish corresponding predictive models.",[28],[90,91],"hepatitis B immunoglobulin","functional cure","2025-12-27",{"date":94,"type":35},"2026-01-09",{"date":96,"type":22},"2026-01-01",{"date":98,"type":22},"2028-12-31",{"name":100,"class":101},"Peking University People's Hospital","OTHER"]