CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)drug
Likely dose
Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00575042
NCT00575042Phase 2Completed
CompareCT.gov

Pilot Study of Fenofibrate for Primary Biliary Cirrhosis

University of Florida·interventional·Posted Dec 17, 2007·Updated Mar 8, 2018

In Brief

A Phase 2 clinical trial evaluating Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) for Primary Biliary Cirrhosis. Completed, enrolled 20 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cirrhosis
CountriesUnited States
CollaboratorsThe PBCers Organization, Shionogi Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2007
Enrollment StartAug 1, 2007
Primary CompletionAug 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.5 years ago

Interventions

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

160 mg per day for 1 year