Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Ki vehet részt

• 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
• Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor; The histology was consistent with the diagnosis of liver cirrhosi; Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension; 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; Abnormal laboratory inspection indicators (2 out of 4): 1) PLT < 100 × 109/L, and no other reason can be explained; 2) Serum albumin<35 g/L, 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/PLT (APRI)>2）
• Incomplete response to UDCA defined by ALP > 1.67 x ULN
• Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Ki nem vehet részt

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