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

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.