This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening/Baseline Period (4 weeks) and a Dosing/Observation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).
Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;
Documented history of chronic hepatitis B and/or positive for hepatitis B surface antigen (HBsAg) for ≥6 months;
No prior systemic antiviral therapy (e.g., interferon and/or nucleos(t)ide analogues) before randomization;
Positive for HBV DNA;
Total bilirubin (TBil) >3 × ULN, or 3 × ULN < ALT <8 × ULN with TBil >2 × ULN;
Platelet count (PLT) ≤50 × 10⁹/L;
Prothrombin activity (PTA) <50% or International Normalized Ratio (INR) >1.5;
Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) >100 μg/L even in the absence of specific signs of hepatocellular carcinoma;
Parallel
Hydronidone (270mg)
DrugDosage: 30 mg/capsule, three capsules taken three times daily, resulting in a total daily therapeutic dose of 270 mg. The medication is administered orally half an hour before meals.
Hydronidone (Placebo Group)
DrugDosage: three capsules taken three times daily.The medication is administered orally half an hour before meals.
Incidence of Clinical Endpoint Events
The clinical endpoint event is a composite event, which includes progression to complications of decompensated cirrhosis (such as ascites, esophageal and gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy, etc.), hepatocellular carcinoma, liver transplantation, and liver disease-related death/all-cause death. The time of event occurrence is determined by whichever occurs first, and the occurrence of any of these events constitutes a clinical endpoint event.
Annualized Incidence Rate of Clinical Endpoint Events
The incidence rates of individual components of the clinical endpoint events
The annualized incidence rates of individual components of the clinical endpoint events
Change from baseline in liver stiffness measurement (LSM) by transient elastography (kPa) after treatment.
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Beijing Continent Pharmaceutical Co, Ltd.
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
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