Use of Fenofibrate for Primary Biliary Cirrhosis

University of Florida

Status and phase

Completed

Phase 2

Conditions

Primary Biliary Cirrhosis

Treatments

Drug: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00575042

405-2006

Details and patient eligibility

About

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.

Full description

This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic index -Mayo risk score and 3) the NIDDK quality of life questionnaire.

Enrollment

20 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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