A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis

This is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Eligible participants will be sequentially enrolled to receive hydronidone capsules 120 mg three times daily (TID) for 28 consecutive days. Participants will return to the hospital on Day 28 after the first dose for a follow-up safety assessment. All adverse events (AEs) and concomitant medications must be recorded during the study period. Participants who complete the Day 28 follow-up visit are considered to have completed the study.

NCT Number	NCT07343778
Lead Sponsor	Beijing Continent Pharmaceutical Co, Ltd.
Conditions	Chronic Hepatitis B With Hepatic Fibrosis
Enrollment	337 participants
Start Date	2026-03-16
Primary Completion	2026-07-28 (estimated)
Study Completion	2026-07-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-13