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;
Beijing Continent Pharmaceutical Co, Ltd.
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator