Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
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
• Male or female with a diagnosis of PBC, by at least two of the following criteria:
‣ History of alkaline phosphatase(ALP) above upper limit of normal(ULN) for at least six months;
⁃ Positive Anti-mitochondrial antibody (AMA) titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
⁃ Documented liver biopsy result consistent with PBC.
• Incomplete response to UDCA defined by 1 x ULN\< ALP \<= 1.67 x ULN
• Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0