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History of AP above ULN for at least six months;\n  2. Positive AMA titers (\\>1\u002F40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;\n  3. Documented liver biopsy result consistent with PBC.\n* Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor\n\n  1. The histology was consistent with the diagnosis of liver cirrhosi;\n  2. Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;\n  3. Ultrasound or CT and other imaging examinations indicate the characteristics of liver cirrhosis or portal hypertension, such as splenomegaly, portal vein ≥ 1.3 cm, or liver stiffness measured by transient elastography\\>16.9 kPa;\n  4. Abnormal laboratory inspection indicators (2 out of 4): 1) PLT \\\u003C 100 × 109\u002FL, and no other reason can be explained; 2) Serum albumin\\\u003C35 g\u002FL, excluding malnutrition or kidney disease and other causes; 3) INR \\> 1.3 or PT prolongation (stop thrombolytic or anticoagulant drugs for more than 7 days); 4) AST\u002FPLT (APRI)\\>2）\n* Incomplete response to UDCA defined by ALP \\> 1.67 x ULN\n* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases.\n* ALT or AST \\> 5×ULN, TBIL \\> 3×ULN.\n* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n* Allergic to fenofibrate or ursodeoxycholic acid.\n* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.\n* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.\n* 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).\n* Creatinine \\>1.5×ULN and creatinine clearance \\\u003C60 ml\u002Fmin.\n* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).\n* Planned to receive an organ transplant or an organ transplant recipient.\n* Needing Liver transplantation within 1 year according to the Mayo Rick score.\n* Any other condition(s) that would compromise the safety of the subject or compromise","ALL","18 Years","75 Years",{"count":224,"type":225},104,"ESTIMATED","INTERVENTIONAL",[228,229],"PHASE2","PHASE3","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).",[232],"Primary Biliary Cholangitis","2026-01-06",{"date":235,"type":236},"2026-01-08","ACTUAL",{"date":238,"type":236},"2023-02-17",{"date":240,"type":225},"2027-12-31",{"name":5,"class":6},12]