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NCT04663308 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
A Phase 2 study of Primary Sclerosing Cholangitis, sponsored by Mirum Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 182
- Enrollment target
- 20
- Study locations
NCT04663308 is a Phase 2 study of Primary Sclerosing Cholangitis that is active but no longer recruiting, run by Mirum Pharmaceuticals. The registered enrollment target is 182 participants, below the 545-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04663308, a Phase 2 study of Primary Sclerosing Cholangitis, is active but no longer recruiting, sponsored by Mirum Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 182 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Volixibat
Study Locations (20)
New York
- Northwell Health - Manhasset
- New York University Langone Health - New York
- Weill Cornell Medical College - New York
- Columbia University Medical Center - Presbyterian Hospital and Vanderbilt Clinic - New York
- University of Rochester Medical Center - Strong Memorial Hospital - Rochester
California
- Southern California Research Center - Coronado
- Cedars Sinai Medical Center - Los Angeles
- University of California, Davis - Sacramento
- California Pacific Medical Center Research Institute - San Francisco
Florida
- Florida Research Institute - Lakewood Rch
- University of Miami - Schiff Center for Liver Diseases - Miami
- Tampa General Hospital - Tampa
North Carolina
- Duke Health - Duke University Medical Center - Durham
- Science 37, Inc (Remote-homebased Telemedicine) - Morrisville
Colorado
- University of Colorado - Anschutz Medical Campus - Aurora
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04663308
The ClinicalTrials.gov registry entry for NCT04663308 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 545-participant average among 23 other Primary Sclerosing Cholangitis trials with a reported enrollment target (67% lower). The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04663308 reports 20 study locations spanning 10 distinct geographic areas - top geographies include New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04663308 about?
NCT04663308 is a clinical study titled "A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)". The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
What is the current status of trial NCT04663308?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2020-12-18. Estimated completion is 2027-04.
What conditions does trial NCT04663308 study?
This clinical trial studies the following conditions: Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT04663308?
The interventions under investigation include: Placebo (DRUG), Volixibat (DRUG).
Who is sponsoring clinical trial NCT04663308?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04663308 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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