The REPLACE Registry for Cholbam® (Cholic Acid)
← catalyst calendarNCT03115086 · readout ≤ 4,364 d
Sponsored by Mirum Pharmaceuticals, Inc. (industry) · MIRM — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
55estimated
Sites
24
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-07-10 | actual | When the study began enrolling |
| Primary completion | Jul 2038 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2039 | estimated | The whole study's end, after follow-up |
| First posted | 2017-04-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Bile Acid Synthesis Disorders
Intervention
- Drug: Cholbam
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with worsening cholestasis
measured 10 Years
Number of participants with new-onset cholestasis
measured 10 Years
Number of participants with steatorrhea leading to poor growth
measured 10 Years
Changes in serum levels of fat-soluble vitamins
measured 10 Years
Neuropathic signs or symptoms related to fat-soluble vitamin deficiencies
measured 10 Years
Number of participants with growth failure
measured 10 Years
Death
measured 10 Years
Adverse effects on pregnancy, pregnancy outcomes, and infant status
measured 10 Years
All Adverse Events (AEs) and Serious AEs (SAEs)
measured 10 years
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