drugset / Trial / NCT05905172

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

NCT05905172

Phase 3 Recruiting 248 enrolled Beijing Continent Pharmaceutical Co, Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-08-12
Primary completion
2028-06-20
Completion
2028-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydronidone Small molecule 270 mg