Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)

Inclusion Criteria:

• Must have provided written informed consent
• Age 18-75 years;
• BMI 17-28 kg/m2
• Completed in a PBC study with fenofibrate(NCT06591455)

Exclusion Criteria:

• Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.;
• Transaminases >5 x ULN or total bilirubin >3 x ULN;
• Pregnant or breastfeeding women, or women planning to conceive during the study period;
• Allergy to fenofibrate or ursodeoxycholic acid;
• Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use;
• Variceal bleeding, hepatic encephalopathy, or ascites at diagnosis or previously;
• History of severe cardiac, cerebrovascular, renal, or respiratory disease or failure, or psychiatric illness (including psychiatric illness caused by alcohol or drug abuse);
• Creatinine >1.5 x ULN and creatinine clearance <60 mL/min;
• Current use of statins (e.g., pravastatin, fluvastatin, simvastatin), other fibrates (e.g., gemfibrozil, bezafibrate), or structurally related drugs (e.g., ketoprofen);
• Planned organ transplantation or previous organ transplantation;
• Need for liver transplantation within 1 year according to the Mayo risk score;
• Any other condition considered unsuitable for enrollment by the investigator.