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

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders affecting drug absorption at the time of screening.
• Total bilirubin (TBIL) > 3 × upper limit of normal (ULN), or ALT > 3 × ULN but < 8 × ULN and TBIL > 2 × ULN.
• Alpha-Fetoprotein (AFP) > 100 μg/L, even in the absence of clinical indications of hepatocellular carcinoma.
• Platelet count (PLT) ≤ 50 × 10⁹/L; Prothrombin activity (PTA) < 50% or International Normalized Ratio (INR) > 1.5.
• Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any infectious event requiring systemic anti-infective therapy.
• Positive test for Human Immunodeficiency Virus antibody (HIV-Ab).
• History of definite malignant tumors, or clinically significant dysfunction of major organs including heart, lungs, or kidneys, as well as clinically significant severe hepatic dysfunction unrelated to the underlying liver disease (e.g., manifestations of decompensated cirrhosis).
• Pregnant or lactating women.
• Participation in any other clinical trial and receipt of investigational drugs within 3 months prior to screening.
• Any other condition deemed by the investigator as unsuitable for enrollment or likely to prevent completion of the study.