Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
Primary Biliary Cirrhosis
About this trial
This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring Primary Biliary Cirrhosis, Primary Biliary Cholangitis, Bezafibrate, Ursodeoxycholic acid
Eligibility Criteria
Inclusion Criteria:
Primary biliary cirrhosis diagnosis made by 2 of the 3 criteria:
- Biochemical evidence of cholestasis with an alkaline phosphatase rise of 1.5 times the upper normal limit.
- Anti-mitochondrial antibodies positivity
- 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:
- Alkaline phosphatase more or equal to 1.5 times the normal upper limit
- Aspartate transaminase more or equal to 1.5 times the normal upper limit
- 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
Sites / Locations
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Bezafibrate & Ursodeoxycholic acid
Placebo & Ursodeoxycholic acid
Bezafibrate 200 mg capsule every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 12 months
Placebo capsule (for bezafibrate 200 mg capsule) every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 12 months