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NCT03115086 · ClinicalTrials.gov registry record
The REPLACE Registry for Cholbam® (Cholic Acid)
A clinical trial of Bile Acid Synthesis Disorders, sponsored by Mirum Pharmaceuticals.
- Active
- Registry status
- 55
- Enrollment target
- 20
- Study locations
NCT03115086 is a study of Bile Acid Synthesis Disorders that is active but no longer recruiting, run by Mirum Pharmaceuticals. The registered enrollment target is 55 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT03115086, a study of Bile Acid Synthesis Disorders, is active but no longer recruiting, sponsored by Mirum Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- 55 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, observational, non-interventional patient registry study designed to document product safety and effectiveness outcomes for 10 years in patients treated with Cholbam, including those who have been using Cholbam for at least 30 days (existing users) and those who are first-time initiators of Cholbam.
Conditions Studied
Interventions
- DRUG Cholbam
Study Locations (20)
Florida
- Kidz Pediatric Multispecialty Group - Hollywood
- Nemours duPont Pediatrics Specialty Clinic - Jacksonville
- Nicklaus Children's Hospital - Miami
New York
- Icahn School Of Medicine at Mount Sinai - New York
- Montefiore Medical Center - New York
- Golisano Children's Hospital, URMC - Rochester
California
- Stanford School of Medicine - Palo Alto
- UC San Francisco - San Francisco
Georgia
- Children's Healthcare of Atlanta - Atlanta
- Children's Center For Digestive Health - Atlanta
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
Missouri
- Office of Dr. Esperanza Font-Montgomery MD - Columbia
- Washington University at St Louis - St Louis
Alabama
- University of Alabama Birmingham - Birmingham
Indiana
- The Community Health Clinic - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2039-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03115086
The ClinicalTrials.gov registry entry for NCT03115086 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bile Acid Synthesis Disorders appearing as the primary indexed condition, and to 1 intervention - of which Cholbam is the first listed.
NCT03115086 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, New York, California.
Frequently Asked Questions
What is clinical trial NCT03115086 about?
NCT03115086 is a clinical study titled "The REPLACE Registry for Cholbam® (Cholic Acid)". This is a prospective, observational, non-interventional patient registry study designed to document product safety and effectiveness outcomes for 10 years in patients treated with Cholbam, including those who have been using Cholbam for at least 30 days (existing users) and those who are first-time...
What is the current status of trial NCT03115086?
This trial is currently active not recruiting. The enrollment target is 55 participants. The study started on 2017-07-10. Estimated completion is 2039-07.
What conditions does trial NCT03115086 study?
This clinical trial studies the following conditions: Bile Acid Synthesis Disorders.
What interventions are being tested in trial NCT03115086?
The interventions under investigation include: Cholbam (DRUG).
Who is sponsoring clinical trial NCT03115086?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03115086 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.