NCT00575042

Use of Fenofibrate for Primary Biliary Cirrhosis

Pilot Study of Fenofibrate for Primary Biliary Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)	160 mg per day for 1 year

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-08-01
• Completion: 2010-08-01
• First posted: 2007-12-17
• Last updated: 2018-03-08
• Results posted: 2012-01-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study