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NCT01904058 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
A Phase 2 study of Primary Biliary Cirrhosis and PBC, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT01904058: Completed Phase 2 study of Primary Biliary Cirrhosis and PBC, sponsored by Mirum Pharmaceuticals.
NCT01904058 is a Phase 2 study of Primary Biliary Cirrhosis and PBC that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 66 participants, below the 1,433-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904058, a Phase 2 study of Primary Biliary Cirrhosis and PBC, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.
Primary Outcome
Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LUM001
- DRUG Ursodeoxycholic Acid
Study Locations (20)
California
- Scripps Clinic - La Jolla
- University of California at Davis - Sacramento
Minnesota
- Mayo Clinic - Rochester
- Minnesota Gastroenterology - Saint Paul
Texas
- University of Texas Southwestern Medical Center - Dallas
- Advanced Liver Therapies at St. Lukes Episcopal Hospital - Houston
Virginia
- Liver Institute of Virginia - Newport News
- Hunter Holmes McGuire VA Medical Center - Richmond
England
- University of Birmingham - Birmingham
- Royal Liverpool & Broadgreen University Hospital - Liverpool
Florida
- University of Miami - Miami
Illinois
- University of Chicago Medical Center - Chicago
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01904058 record still lists
NCT01904058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,433-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Primary Biliary Cirrhosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01904058 names 20 study sites across 15 states, led by California, Minnesota, Texas.
Frequently Asked Questions
What is clinical trial NCT01904058 about?
NCT01904058 is a clinical study titled "Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis". The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.
What is the current status of trial NCT01904058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2013-08. Estimated completion is 2015-04.
What conditions does trial NCT01904058 study?
This clinical trial studies the following conditions: Primary Biliary Cirrhosis, PBC.
What interventions are being tested in trial NCT01904058?
The interventions under investigation include: Placebo (DRUG), LUM001 (DRUG), Ursodeoxycholic Acid (DRUG).
Who is sponsoring clinical trial NCT01904058?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01904058 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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