drugset / Trial / NCT00575042
Use of Fenofibrate for Primary Biliary Cirrhosis
Phase 2
Completed
20 enrolled
University of Florida
Shionogi · collabThe PBCers Organization · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-08
- Primary completion
- 2009-08
- Completion
- 2010-08
Outcome
Met primary endpoint
registry Patients Before Treatment With Fenofibrate vs Patients Treated With Fenofibrate; p <0.0001; Wilcoxon (Mann-Whitney) NCT00575042 ↗
Publications
- Background 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.
- Results Levy C, Peter JA, Nelson DR, Keach J, Petz J, Cabrera R, Clark V, Firpi RJ, Morelli G, Soldevila-Pico C, Lindor K. Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. Aliment Pharmacol Ther. 2011 Jan;33(2):235-42. doi: 10.1111/j.1365-2036.2010.04512.x. Epub 2010 Nov 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenofibrate | Small molecule | 160 mg | — |