A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

Launched by HAN YING · Sep 7, 2024

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Eligibility criteria

• Inclusion Criteria:
• • Must have provided written informed consent
• • Age 18-75 years;
• • BMI 17-28 kg/m2
• * Male or female with a diagnosis of PBC, by at least two of the following criteria:
• • 1. History of AP above ULN for at least six months;
• • 2. Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
• • 3. Documented liver biopsy result consistent with PBC.
• • Not receiving UDCA treatment before enrollment, ALP\>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