Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders

Launched by INSTITUTO NACIONAL DE CIENCIAS MEDICAS Y NUTRICION SALVADOR ZUBIRAN · Oct 14, 2016

Keywords

ClinConnect Summary

There are case reports and pilot studies in patients with primary biliary cholangitis (PBC) In the literature in which the effect of fibrates (specially bezafibrate) on the improvement of biochemical cholestasis have been seen, however the clinical benefit (survival, mortality, fatigue, pruritus) has not been reported and likewise the response criteria used in previous studies is very heterogeneous. In previous studies, bezafibrate has been proved to be a secure drug in this patients, with few adverse events, also it is an economic and of easy access drug. For all this the investigators int...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Primary biliary cirrhosis diagnosis made by 2 of the 3 criteria:
• • 1. Biochemical evidence of cholestasis with an alkaline phosphatase rise of 1.5 times the upper normal limit.
• • 2. Anti-mitochondrial antibodies positivity
• • 3. Histopathologic evidence of a nonsuppurative cholangitis and small bile ducts destruction
• • Use of ursodeoxycholic acid (UDCA) for at least 6 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day)
• * Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria:
• • 1. Alkaline phosphatase more or equal to 1.5 times the normal upper limit
• • 2. Aspartate transaminase more or equal to 1.5 times the normal upper limit
• • 3. Bilirubin more than 1 mg/dL
• • Signed informed consent.
• Exclusion Criteria:
• • No informed consent given to enrollment
• • Actual or history of hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy)
• • Secondary immunosuppression caused by drugs (for example; steroids), use of statins or fibrates in the last 6 months. The investigators will exclude patients with medical indication of statin use.
• • Coexistence of hepatopathy, chronic viral infections like C hepatitis virus, B virus and HIV. Excessive alcohol intake, autoimmune hepatitis, non-alcoholic fatty liver disease (diagnosed by histopathology), Wilson disease, hemochromatosis, celiac disease, choledocolithiasis, non-controlled thyroid disease
• • Post liver transplant
• • Known allergy or intolerance to fibrates
• • Pregnancy or women who desire to become pregnant
• • Chronic kidney disease with a glomerular filtration less than 60 ml/min
• • Patients under total anticoagulation with vitamin K antagonist