Clinical Trial: Use of Fenofibrate for Primary Biliary Cirrhosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot Study of Fenofibrate for Primary Biliary Cirrhosis

Brief 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.

Detailed Summary: 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.
Sponsor: University of Florida

Current Primary Outcome: Serum Level of Alkaline Phosphatase [ Time Frame: 1 year ]

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


Original Primary Outcome: Serum level of alkaline phosphatase, serum immunoglobulin M level and Mayo risk score [ Time Frame: 1 year ]

Current Secondary Outcome: Quality of Life According to NIDDK Questionnaire [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: December 13, 2007
Date Started: August 2007
Date Completion:
Last Updated: December 2, 2011
Last Verified: August 2011