Clinical Trial

The REPLACE Registry for Cholbam® (Cholic Acid)

Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2017-04-10; most recent amendment 2023-09-29.
Status change: Recruiting → Active, Not Recruiting 2023-02-06
Status change: Not Yet Recruiting → Recruiting 2017-06-28
Trial Details
NCT Number NCT03115086
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions Bile Acid Synthesis Disorders
Enrollment 55 participants
Start Date 2017-07-10
Primary Completion 2038-07 (estimated)
Study Completion 2039-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-31