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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: Active study of Bile Acid Synthesis Disorders, sponsored by Mirum Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Worsening cholestasis will be identified by measuring direct total bilirubin concentration in blood and will be defined as a 25% increase from previous measurement if the total bilirubin is \>1mg/dL.
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 |
What the registry record for NCT03115086 still lists
NCT03115086 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target.
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 names 20 study sites across 12 states, led by 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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