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NCT00575042 · ClinicalTrials.gov registry record · Phase 2
Use of Fenofibrate for Primary Biliary Cirrhosis
A Phase 2 study of Primary Biliary Cirrhosis, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT00575042: Completed Phase 2 study of Primary Biliary Cirrhosis, sponsored by University of Florida.
NCT00575042 is a Phase 2 study of Primary Biliary Cirrhosis that has completed, run by University of Florida. The registered enrollment target is 20 participants, below the 1,439-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00575042, a Phase 2 study of Primary Biliary Cirrhosis, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.
Conditions Studied
Interventions
- DRUG Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
Study Locations (2)
Florida
- University of Florida - Gainesville
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-08 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00575042 record still lists
NCT00575042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,439-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Primary Biliary Cirrhosis appearing as the primary indexed condition, and to 1 intervention - of which Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) is the first listed.
NCT00575042 reports a single indexed study location in Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00575042 about?
NCT00575042 is a clinical study titled "Use of Fenofibrate for Primary Biliary Cirrhosis". 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.
What is the current status of trial NCT00575042?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2007-08. Estimated completion is 2010-08.
What conditions does trial NCT00575042 study?
This clinical trial studies the following conditions: Primary Biliary Cirrhosis.
What interventions are being tested in trial NCT00575042?
The interventions under investigation include: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) (DRUG).
Who is sponsoring clinical trial NCT00575042?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00575042 being conducted?
This trial has 2 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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