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Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis

NCT01141296 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-04-02

No results posted yet for this study

Summary

The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

fenofibrate

fenofibrate 200 mg PO daily for 1 year

DRUG

placebo

Placebo pill identical to active drug will be given PO once a day for 1 year

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Cynthia Levy, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01141296 on ClinicalTrials.gov