Clinical Trial

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

Completed Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Trial completed 2026-08-14
notable Enrollment increased: 200 -> 411 participants 2026-08-14
notable Primary completion moved earlier: 2026-07-30 -> 2026-06-22 2026-08-14
minor Completion moved earlier: 2026-08-30 -> 2026-06-22 2026-08-14
critical Recruitment opened 2026-04-03
Trial Details
NCT Number NCT07364448
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Collaborators: The First Hospital of Jilin University
Conditions Chronic Hepatitis B With Hepatic Fibrosis
Enrollment 411 participants
Start Date 2026-03-12
Primary Completion 2026-06-22 (estimated)
Study Completion 2026-06-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-13