Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Jun 30, 2016

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent
• • 2. Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP \> 1,5N) and aminotransferase (AST/ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC.
• Exclusion Criteria:
• • 1. Pregnancy or desire of pregnancy.
• • 2. Breast-feeding.
• • 3. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
• • 4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
• • 5. History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
• • 6. Hepatotoxic drugs use before recruiting.
• • 7. Fenofibrate anaphylaxis.