Randomized, Double-blind, Placebo-controlled, Entecavir-based Phase IIIb Trial of Hydronidone Capsule for Liver Fibrosis in Chronic Hepatitis B

What this Trial Is About

Researchers are evaluating the long-term treatment of liver fibrosis in patients with chronic viral hepatitis B. This Phase IIIb extension trial builds on a previous randomized, double-blind, placebo-controlled study that assessed hydronidone capsules. The aim is to assess how effective and safe hydronidone capsules are over an extended period in managing liver fibrosis progression and reducing clinical endpoint events related to liver disease. Participants receive either hydronidone capsules or placebo capsules three times daily, with each dose consisting of three capsules taken half an hour before meals. Both groups also receive entecavir antiviral therapy once daily, or an alternative antiviral if entecavir is unsuitable. The treatment period in this extension trial lasts for five years, continuing the original protocol from the prior Phase III study. Throughout the study, participants undergo regular assessments including clinical laboratory tests every six months, evaluation of liver enzymes (ALT and AST), hepatitis B viral load measurement, and transient elastography to monitor liver stiffness. The researchers track the cumulative incidence of clinical endpoint events over five years to evaluate treatment outcomes. The study also allows some flexibility in the frequency of examinations to improve participant compliance while maintaining at least yearly evaluations.

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