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A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
Sponsor: Beijing Continent Pharmaceutical Co, Ltd.
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
Hydronidone Capsules
120mg TID for 28 consecutive days
Locations (1)
The Sixth People's Hospital of Zhengzhou City
Zhengzhou, China