Use of Fenofibrate for Primary Biliary Cirrhosis

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: Shionogi Inc.; The PBCers Organization
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

• Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)

• Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year

• Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal on two separate measurements

• Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period

• Signed informed consent after careful review of the information and study details by one of the investigators

Exclusion Criteria

• Hypersensitivity to fenofibrate

• Prisoners and institutionalized subjects

• Pregnant or nursing women

• Anticipated need for liver transplantation in one year (estimated one year survival < 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.

• Recipients of liver transplantation

• Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites

• Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma

• Acute or chronic renal failure

• Known history of cholecystitis with intact gallbladder

• Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity