Use of Fenofibrate for Primary Biliary Cirrhosis
Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Biliary Cirrhosis
Intervention: Fenofibrate (Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Florida Official(s) and/or principal investigator(s): Cynthia Levy, MD, Principal Investigator, Affiliation: University of Florida
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.
Clinical Details
Official title: Pilot Study of Fenofibrate for Primary Biliary Cirrhosis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serum Level of Alkaline Phosphatase
Secondary outcome: Quality of Life According to NIDDK Questionnaire
Detailed 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.
Eligibility
Minimum age: 21 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
University of Florida, Gainesville, Florida 32610, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Related publications: Levy C, Peter J, Keach J, Petz J, Lindor KD, Cabrera R, et al. Fenofibrate improves liver biochemistries in primary biliary cirrhosis. Hepatology. 2009;50(4 (suppl)):995A.
Starting date: August 2007
Last updated: December 2, 2011
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