Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

• Fenofibrate (Drug): Fenofibrate 200mg

Primary outcomes

• Treatment emergent adverse events (TEAEs) [Through study completion, up to 120 Months]

Secondary outcomes

• Normalization of ALP [From enrollment to the end of treatment at 120 months]: Percentage of patients having normalization of ALP
• The changes of liver function indicators [From enrollment to the end of treatment at 120 months]: The changes of liver function indicators compared to baseline: ALP, ALT, AST, GGT, TBIL
• The percentage of patients achieving biochemical response criteria [From enrollment to the end of treatment at 120 months]: The percentage of patients who meet various biochemical response criteria (Paris I, Paris II, and Barcelona, etc.)
• Death [From enrollment to the end of treatment at 120 months]: Occurrence of overall death
• Liver transplantation [From enrollment to the end of treatment at 120 months]: Occurrence of overall liver transplantation

Sex: All, ages: 18 Years to 75 Years

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.