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

Prior treatment

• History or presence of other concomitant liver diseases.
• Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
• 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.

Other illness

• Allergic to fenofibrate or ursodeoxycholic acid.
• 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).
• Any other condition(s) that would compromise the safety of the subject or compromise

Lab values

• 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.
• Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.

• Voluntarily joining the group, able to understand and sign an informed consent form;
• 18 years old ≤ age ≤ 75 years old;
• The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: AMA or gp210, sp100 positive; Elevated serum ALP levels; Pathological manifestations include non suppurative cholangitis and destruction of the interlobular bile duct;
• Liver histology suggests moderate to severe interfacial hepatitis (moderate,\&lt;50% portal or fibrous septa destruction, severe,\&gt;50% portal or fibrous septa destruction) with serum ALT\&lt;5 \* ULN, serum IgG\&lt;2 \* ULN, and negative serum anti smooth muscle antibodies;
• Not receiving UDCA, hormone or other immunosuppressive therapy before enrollment;
• ALP\&gt;1.67 \* ULN.