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Active, not recruiting No phase listed Observational

The REPLACE Registry for Cholbam® (Cholic Acid)

ClinicalTrials.gov ID: NCT03115086

Public ClinicalTrials.gov record NCT03115086. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 4:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Observational, Non-Interventional, Post-Marketing, Patient Registry to Collect Data on Routine Clinical Care in Patients Treated With Cholbam® (Cholic Acid)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03115086
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Enrollment
55 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 10, 2017 (Actual)
Primary completion
Jul 2038 (Estimated)
Completion
Jul 2039 (Estimated)
Last update posted
Jul 31, 2026

2017 – 2039

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
21
Facility City State ZIP Site status
University of Alabama Birmingham Birmingham Alabama 35233 —
Stanford School of Medicine Palo Alto California 94305 —
UC San Francisco San Francisco California 94158 —
Kidz Pediatric Multispecialty Group Hollywood Florida 33021 —
Nemours duPont Pediatrics Specialty Clinic Jacksonville Florida 32207 —
Nicklaus Children's Hospital Miami Florida 33155 —
Children's Healthcare of Atlanta Atlanta Georgia 30329 —
Children's Center For Digestive Health Atlanta Georgia 30342 —
The Community Health Clinic Topeka Indiana 46571 —
Ochsner Hospital for Children New Orleans Louisiana 70121 —
University of Minnesota Minneapolis Minnesota 55454 —
Mayo Clinic Rochester Minnesota 55902 —
Office of Dr. Esperanza Font-Montgomery MD Columbia Missouri 65201 —
Washington University at St Louis St Louis Missouri 63110 —
NYU Langone - NYU Grossman School of Medicine New York New York 10016 —
Icahn School Of Medicine at Mount Sinai New York New York 10029 —
Montefiore Medical Center New York New York 10032 —
Golisano Children's Hospital, URMC Rochester New York 14642 —
UNC Chapel Hill Chapel Hill North Carolina 27599 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
University of Oklahoma Oklahoma City Oklahoma 73104 —
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Monroe-Carell Jr. Children's Hospital at Vanderbilt Nashville Tennessee 37232 —
Primary Children's Hospital Salt Lake City Utah 84113 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03115086, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03115086 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →