NCT07364448

A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis

An Open-label, Single-arm Clinical Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis . Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.

Conditions

• Chronic Hepatitis B With Hepatic Fibrosis

Interventions

Type	Name	Description
DRUG	Hydronidone capsules	three times a day, 3 capsules each time,

Timeline

• Start date: 2026-03-12
• Primary completion: 2026-07-30
• Completion: 2026-08-30
• First posted: 2026-01-23
• Last updated: 2026-04-02

Locations

1 site across 1 country: China