A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics

Exclusion Criteria

• •History or presence of other concomitant liver diseases.
• •ALT or AST \> 5×ULN, TBIL \> 3×ULN.
• •If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
• •Allergic to fenofibrate or ursodeoxycholic acid.
• •Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
• •Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
• •Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
• •Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
• •Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
• •Planned to receive an organ transplant or an organ transplant recipient.
• •Needing Liver transplantation within 1 year according to the Mayo Rick score.
• •Any other condition(s) that would compromise the safety of the subject or compromise