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RECRUITING
NCT07343778
PHASE3

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

Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-03-16

Completion Date

2026-10-30

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Hydronidone Capsules

120mg TID for 28 consecutive days

Locations (1)

The Sixth People's Hospital of Zhengzhou City

Zhengzhou, China