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Use of Fenofibrate for Primary Biliary Cirrhosis

NCT00575042 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-03-08

Study results available
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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.

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

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

160 mg per day for 1 year

Sponsors & Collaborators

  • The PBCers Organization

    collaborator OTHER

  • Shionogi Inc.

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Cynthia Levy, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-08-31
Completion
2010-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00575042 on ClinicalTrials.gov