The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).
Must have provided written informed consent
Age 18-75 years;
BMI 17-28 kg/m2
History of AP above ULN for at least six months;
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.