Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

Prior treatment

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

Other illness

• Allergic to fenofibrate or ursodeoxycholic acid.
• 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).
• Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator.

Lab values

• ALT/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.
• Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.

• 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 AP above ULN for at least six months;
  • Positive 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 Xi'an criteria (ALP \>2.5× ULN, AST\>2×ULN or TBIL\>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.