Trial Profile

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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 28 May 2025

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At a glance

Drugs Hydronidone (Primary)
Indications Hepatic fibrosis
Focus Registrational; Therapeutic Use
Sponsors Beijing Continent Pharmaceutical

Most Recent Events

22 May 2025 According to Gyre Therapeutics media release,Based on positive results from this study the company plans to file an NDA with Chinas NMPA in the third quarter of 2025.
22 May 2025 Primary endpoint (Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline.) has been met.
22 May 2025 Results presented in the Gyre Therapeutics Media Release.

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