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

Prior treatment

• 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.
• 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.
• Participation in any other clinical trial and receipt of investigational drugs within 3 months prior to screening.

Other illness

• 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).
• Any other condition deemed by the investigator as unsuitable for enrollment or likely to prevent completion of the study.

Lab values

• 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.

Other

• Pregnant or lactating women.

• 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.