A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis

This trial employs a single-arm, open-label, multicenter clinical trial design. All study participants who meet the inclusion/exclusion criteria will receive Hydronidone treatment for 4 weeks. The study includes a screening period (up to 21 days) to assess the eligibility of participants. Eligible participants will enter the treatment period and receive Hydronidone capsules at a dosage of 270 mg TID (30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals) for 28 consecutive days. Participants will return for a follow-up visit on Day 28 (±3 days) after the first dose for safety assessments. All adverse events (AEs) and concomitant medications occurring during the study period must be recorded. After the treatment period, participants will enter a follow-up period to monitor any delayed adverse events. Participants who complete the final follow-up visit are considered to have completed the study. Throughout the study, participants must maintain the stability of all their pre-existing treatment regimens, including antiviral therapy and medications for other comorbid conditions.

NCT Number	NCT07417553
Lead Sponsor	Beijing Continent Pharmaceutical Co, Ltd. Collaborators: The Second Affiliated Hospital of Chongqing Medical University
Conditions	Chronic Hepatitis B-related Liver Fibrosis
Enrollment	67 participants
Start Date	2026-04-15
Primary Completion	2026-07-27 (estimated)
Study Completion	2026-07-27 (estimated)
Updated on ClinicalTrials.gov	2026-08-13