Use of Fenofibrate for Primary Biliary Cirrhosis
Pilot Study of Fenofibrate for Primary Biliary Cirrhosis
  • Phase

    Phase 2
  • Study Type

  • Intervention/Treatment

    fenofibrate ...
  • Study Participants

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.
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.
Study Started
Aug 31
Primary Completion
Aug 31
Study Completion
Aug 31
Results Posted
Jan 09
Last Update
Mar 08

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

160 mg per day for 1 year

  • Other names: Triglide-Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)

Patients treated with Fenofibrate Experimental

Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg table per day for 1 year


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


Patients Treated With Fenofibrate

All Events

Event Type Organ System Event Term Patients Treated With Fenofibrate

Serum Level of Alkaline Phosphatase

We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.

Patients Before Treatment With Fenofibrate

U/L (Median)
Full Range: 214.0 to 779.0

Patients Treated With Fenofibrate

U/L (Median)
Full Range: 60.0 to 384.0

Age, Continuous

years (Mean)
Standard Deviation: 8.9

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Fenofibrate 160 mg Per Day

Drop/Withdrawal Reasons

Fenofibrate 160 mg Per Day