[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hepatitis-b-with-hepatic-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hepatitis-b-with-hepatic-fibrosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100620963","phase-2-a-study-to-evaluate-the-safety-of-hydronidone-capsules-in-patients-with-liver-fibrosis-100620963",false,"NCT07364448","A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis","An Open-label, Single-arm Clinical Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.\n* Patients assessed by the investigator as having chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated cirrhosis) based on histology, imaging, or laboratory markers, meeting any of the following criteria:\n\nHistologically confirmed diagnosis of hepatic fibrosis (F2 or above);\n\nEndoscopy showing esophageal or gastric varices or ectopic gastrointestinal varices, excluding non-cirrhotic portal hypertension;\n\nFor chronic hepatitis B patients: liver imaging suggestive of fibrotic features, with liver stiffness measurement (LSM) ≥ 8.5 kPa, or Fibrosis-4 Index (FIB-4) ≥ 1.45; Or for non-alcoholic fatty liver disease patients: LSM ≥ 8.5 kPa or FIB-4 ≥ 1.3; Or for alcoholic liver disease patients: LSM ≥ 8.5 kPa.\n\n* Subjects who agree to use effective contraception measures as specified below during their participation in the trial:\n\nMale subjects must consistently employ highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product.\n\nFemale subjects participating in this trial must not be pregnant or lactating and must meet at least one of the following conditions:\n\n1. Be a woman of non-childbearing potential (WONCBP), as defined in Appendix 1;\n2. Be a woman of childbearing potential (WOCBP) who consistently uses highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product, and agrees not to donate eggs for reproductive purposes during this period.\n\n   * The patient voluntarily agrees to participate in this trial, demonstrates good compliance, and has the capacity to understand and sign the informed consent form prior to the study.\n\nExclusion Criteria:\n\n* At screening, total bilirubin (TBIL) \\> 3 × upper limit of normal (ULN), or direct bilirubin (DBIL) \\> 2 × ULN, or alanine aminotransferase (ALT) \\> 3 × ULN.\n* At screening, alpha-fetoprotein (AFP) \\> 20 μg\u002FL.\n* At screening, platelet count (PLT) ≤ 75 × 10⁹\u002FL, or international normalized ratio (INR) \\> 1.5.\n* History of or current clinical diagnosis of decompensated cirrhosis at screening, or imaging showing significant space-occupying lesions in the liver (intrahepatic nodules \\> 10 mm), or findings suggestive of malignancy.\n* Diagnosis of any other malignancy within the past 5 years prior to screening, except for radically resected and non-recurrent skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix (excluding the cervical cancer cohort), localized prostate cancer, or other carcinomas in situ.\n* Use of interferon within 3 months prior to screening.\n* Concurrent severe diseases of the cardiovascular, pulmonary, renal, endocrine, neurological, digestive, or hematopoietic systems, or psychiatric disorders.\n* Planned participation in other interventional clinical trials during the study period.\n* Participation in any other clinical trials within 3 months prior to screening.\n* Pregnant and\u002For lactating women.\n* Other conditions deemed unsuitable for inclusion by the investigator.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis .\n\nApproximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.",[26],"Chronic Hepatitis B With Hepatic Fibrosis",[28,29],"Chronic Hepatitis B with Hepatic Fibrosis","Hydronidone","RECRUITING","2026-03-27",{"date":33,"type":34},"2026-04-02","ACTUAL",{"date":36,"type":34},"2026-03-12",{"date":38,"type":20},"2026-08-30",{"name":40,"class":41},"Beijing Continent Pharmaceutical Co, Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100619373","phase-3-a-clinical-trial-evaluating-the-safety-of-hydronidone-capsules-in-patients-with-hepatic-fibrosis-and-liver-cirrhosis-100619373","NCT07343778","A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis","A Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis","Inclusion Criteria:\n\n* Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).\n* Aged ≥18 years, regardless of gender.\n* Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either:\n\nA prior percutaneous liver biopsy (results within 1 year prior to enrollment are acceptable); or\n\nImaging findings (Fibroscan, Fibrotouch, or ultrasound, with results within 3 months prior to enrollment acceptable).\n\n* Alanine aminotransferase (ALT) \\\u003C 8 × upper limit of normal (ULN).\n* Female participants of childbearing potential must have a negative serum pregnancy test. Furthermore, the participant or their partner must agree to employ highly effective contraceptive methods from the start of the trial until 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders affecting drug absorption at the time of screening.\n* Total bilirubin (TBIL) \\> 3 × upper limit of normal (ULN), or ALT \\> 3 × ULN but \\\u003C 8 × ULN and TBIL \\> 2 × ULN.\n* Alpha-Fetoprotein (AFP) \\> 100 μg\u002FL, even in the absence of clinical indications of hepatocellular carcinoma.\n* Platelet count (PLT) ≤ 50 × 10⁹\u002FL; Prothrombin activity (PTA) \\\u003C 50% or International Normalized Ratio (INR) \\> 1.5.\n* Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any infectious event requiring systemic anti-infective therapy.\n* Positive test for Human Immunodeficiency Virus antibody (HIV-Ab).\n* History of definite malignant tumors, or clinically significant dysfunction of major organs including heart, lungs, or kidneys, as well as clinically significant severe hepatic dysfunction unrelated to the underlying liver disease (e.g., manifestations of decompensated cirrhosis).\n* Pregnant or lactating women.\n* Participation in any other clinical trial and receipt of investigational drugs within 3 months prior to screening.\n* Any other condition deemed by the investigator as unsuitable for enrollment or likely to prevent completion of the study.",{"count":51,"type":20},300,[53],"PHASE3","This is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Eligible participants will be sequentially enrolled to receive hydronidone capsules 120 mg three times daily (TID) for 28 consecutive days. Participants will return to the hospital on Day 28 after the first dose for a follow-up safety assessment. All adverse events (AEs) and concomitant medications must be recorded during the study period. Participants who complete the Day 28 follow-up visit are considered to have completed the study.",[26],[57],"Chronic hepatitis B with hepatic fibrosis","2026-03-25",{"date":60,"type":34},"2026-03-31",{"date":62,"type":34},"2026-03-16",{"date":64,"type":20},"2026-10-30",{"name":40,"class":41}]