Clinical Trial

Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis

Recruiting Phase 3
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Summary
This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B". The main objective of this study is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-06-07; most recent amendment 2025-05-30.
Status change: Not Yet Recruiting → Recruiting 2024-01-15
Trial Details
NCT Number NCT05905172
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Conditions Liver Fibrosis
Enrollment 248 participants
Start Date 2023-08-12
Primary Completion 2028-06-20 (estimated)
Study Completion 2028-10-20 (estimated)
Updated on ClinicalTrials.gov 2025-06-04