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NCT01438411 · ClinicalTrials.gov registry record · Phase 3
Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis
A Phase 3 study, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT01438411: Completed Phase 3 study, sponsored by Mirum Pharmaceuticals.
NCT01438411 is a Phase 3 study that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 53 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01438411, a Phase 3 study, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic acid in subjects with identified inborn errors of bile acid synthesis.
Primary Outcome
The level of atypical urinary bile acid secretion was scored using a scale of: 0, normal; 1, slight; 2, significant; or 3, marked. A Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring was used to compare the difference between the score at baseline and the worst post-baseline score during treatment with cholic acid in this single-arm trial.
Interventions
- DRUG Cholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT01438411 record still lists
NCT01438411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Cholic Acid is the first listed.
NCT01438411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01438411 about?
NCT01438411 is a clinical study titled "Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis". The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic acid in subjects with identified inborn errors of bile acid synthesis.
What is the current status of trial NCT01438411?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2010-01. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01438411?
The interventions under investigation include: Cholic Acid (DRUG).
Who is sponsoring clinical trial NCT01438411?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01438411's enrollment target sits among peer trials
53 1839th of 2000 higher than 160 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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