{ "data": { "asOf": "2026-10-30T22:26:31.741Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT03625102", "title": "A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B", "scientificTitle": "A Randomized, Double-Blind, Dosing-Ranging, Placebo-controlled Trial of Antroquinonol in Patients With Chronic Hepatitis B", "status": "completed", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "HBV" ], "interventions": [ { "name": "Antroquinonol", "type": "DRUG", "description": "Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol." }, { "name": "placebo", "type": "OTHER", "description": "The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects" } ], "sponsor": { "name": "Golden Biotechnology Corporation", "type": "INDUSTRY" }, "locations": [ { "city": "Taichung", "country": "Taiwan", "facility": "Chung Shan Medical University Hospital" } ], "outcomes": { "other": [], "primary": [ "quantitative hepatitis B surface antigen (Log qHBsAg)" ], "secondary": [ "Serum hapatitis B virus DNA level", "quantitative hepatitis B surface antigen", "Fibrosis-4 (FIB-4) score", "Hepatitis B surface antigen loss (HBeAg loss)", "Glutamic Oxaloacetic Transaminase (GOT)", "Glutamic Pyruvic Transaminase (GPT)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Chronic HBV infection patients between the ages of 20 and 75 years with serum hepatitis B surface antigen(HBsAg) positivity for more than 6 months\n2. BMI≦35\n3. HBsAg≧10 IU/mL and HBV DNA≧2000 IU/mL.\n4. AST or ALT≧25 IU and ALT\\<5xULN\n5. Female subject must use effective methods of contraception.\n6. No abnormal finding of clinical relevance\n7. Written informed consent\n\nExclusion Criteria:\n\n1. Evidence of hepatic decompensation such as:\n\n 1. Coagulopathy defined as prolongation of prothrombin time greater than 3 seconds\n 2. Total bilirubin of 2 times the upper limit of normal\n 3. FIB-4 of 3.25 or greater\n2. Abnormal hematological and biochemical parameters at screening A、 White blood cell count less than 2500 cells/uL B、 Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for African or African-American subjects) C、 Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females D、 Estimated GFR less than 50 mL/min\n3. Suspected or confirmed liver diseases from etiologies other than HBV (such as alcohol, toxin, drug, shock, acute viral hepatitis A or E), co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis delta virus, prior antiviral treatment with NUCs or interferon, and recent immunosuppressive therapy (including chemotherapy and systemic corticosteroid).\n4. Immunodeficiency disorders or severe autoimmune disease\n5. Severe pulmonary disorders or significant cardiac diseases\n6. Gastrointestinal disorder with post-operative condition that could interfere with drug absorption\n7. Significant psychiatric illness that in the judgment of the Investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent\n8. Any malignancy diagnosed within 5 years or evidence of hepatocellular carcinoma (e.g., α fetoprotein \\> 50ng/mL or radiologic evidence)\n9. Solid organ transplantation\n10. Current drug or alcohol abuse\n11. Pregnancy or lactation\n12. 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