Status: Not yet recruiting
A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.
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).
Participants needed: 1,208
Trial details
Phase: Phase 3Age: 18-65Biological sex: AllType: InterventionalSponsor: Beijing Continent Pharmaceutical Co, Ltd.Updated: Feb 17, 2026Locations: 1
Eligibility criteria
Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the... [+11]
Total bilirubin (TBil) >3 × ULN, or 3 × ULN < ALT <8 × ULN with TBil >2 × ULN; [+10]