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).

NCT Number	NCT07412236
Lead Sponsor	Beijing Continent Pharmaceutical Co, Ltd. Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions	Liver Fibrosis, Liver Fibrosis in Chronic Hepatitis B
Enrollment	1,208 participants
Start Date	2026-01-30
Primary Completion	2028-12-30 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-17