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

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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).
Trial Details
NCT Number NCT07412236
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Liver Fibrosis, Liver Fibrosis in Chronic Hepatitis B
Related terms Liver Cirrhosis
Enrollment 1,208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov