A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.

Summary

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).

Timeline

Start

2026-01-30

Primary completion

2028-12-30

Completion

2028-12-30

Drugs

Indications