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

Launched by HAN YING · Sep 7, 2024

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Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily joining the group, able to understand and sign an informed consent form;
• • 2. 18 years old ≤ age ≤ 75 years old;
• • 3. 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;
• • 4. Liver histology suggests moderate to severe interfacial hepatitis (moderate,\<50% portal or fibrous septa destruction, severe,\>50% portal or fibrous septa destruction) with serum ALT\<5 \* ULN, serum IgG\<2 \* ULN, and negative serum anti smooth muscle antibodies;
• • 5. Not receiving UDCA, hormone or other immunosuppressive therapy before enrollment;
• • 6. ALP\>1.67 \* ULN.
• 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