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
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.
• Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
• Aged ≥18 years, regardless of gender.
• Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either:
⁃ A prior percutaneous liver biopsy (results within 1 year prior to enrollment are acceptable); or
⁃ Imaging findings (Fibroscan, Fibrotouch, or ultrasound, with results within 3 months prior to enrollment acceptable).
• Alanine aminotransferase (ALT) \< 8 × upper limit of normal (ULN).
• Female participants of childbearing potential must have a negative serum pregnancy test. Furthermore, the participant or their partner must agree to employ highly effective contraceptive methods from the start of the trial until 6 months after the last dose of the study drug.