FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy

Prior treatment

• Subjects who have received treatment with obeticholic acid and other fibrates (such as gemfibrozil, bezafibrate, pemafibrate, Elafibranor, Seladelpar, Lanifibranor, Saroglitizar, etc.) within the previous 6 weeks prior to screening;
• Screening for individuals who have taken colchicine, methotrexate, azathioprine, or undergone systemic hormone therapy for more than 2 weeks within the previous 2 months;
• Is currently undergoing treatment with immunosuppressants (such as cyclosporine, tacrolimus, and related biologics);
• Plan to receive organ transplantation or have already undergone organ transplantation;

Other illness

• Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc;
• Individuals who are allergic to fenofibrate or ursodeoxycholic acid;
• At the time of diagnosis or in the past, there have been variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma, and hepatorenal syndrome;
• Individuals with a history of severe diseases or functional failures in the heart, cerebrovascular system, kidneys, respiratory system, as well as mental illnesses (including those caused by alcohol and drug abuse);
• Clear history of HIV infection or HIV antibody positive during the screening period;
• Screen for individuals with a clear history of malignant tumor or anti-tumor treatment within the previous 2 years;

Lab values

• Transaminase greater than 5×ULN, or total bilirubin greater than 3×ULN;
• Creatinine level greater than 1.5×ULN;
• Glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m2;
• International normalized ratio (INR) ≥ 1.5 (for patients undergoing anticoagulant therapy, an INR value within the therapeutic target range is sufficient);

Other

• Pregnant women, lactating women, or those who plan to give birth during the study period;
• Other situations that researchers judge as unsuitable for enrollment.

• Voluntarily join the group and be able to understand and sign the informed consent form;
• Age: 18 years old or above and below 75 years old;
• The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: positive AMA or gp210, sp100; elevated serum ALP; pathological manifestations of non-suppurative cholangitis and interlobular bile duct destruction);
• The patient did not receive UDCA and fenofibrate treatment in the 6 months before enrollment, and ALP was greater than the upper limit of normal (ULN).