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.
Parallel
Fenofibrate 200mg
DrugFenofibrate 200mg/day
Placebo
Drug1 tablet/ day
UDCA
DrugUDCA 13-15mg/kg/day
Percentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Percentage of patients having biochemical response
The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks.
Assessment of the pruritus and fatigue
Change From Baseline in Fatigue and Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome)
Percentage of patients having biological or clinical adverse events
Increase of creatinine
Percentage of patients having biological or clinical adverse events
Increase Blood urea nitrogen
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