Overview

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)

Eligibility

Inclusion Criteria:

• 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:
  1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
  2. 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;
  3. 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

Exclusion Criteria:

• History or presence of other concomitant liver diseases.
• ALT or AST > 5×ULN, total bilirubin（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.
• Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.

        Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory
        ascites.
          -  Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease
             or functional failure, and psychiatric disorders (including those due to alcohol and
             drug abuse).
          -  Creatinine >1.5×ULN and creatinine clearance <60 ml/min.
          -  Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other
             fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to
             fenofibrate (like ketoprofen).
          -  Planned to receive an organ transplant or an organ transplant recipient.
          -  Needing Liver transplantation within 1 year according to the Mayo Rick score.
          -  Any other condition(s) that would compromise the safety of the subject or compromise