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NCT01589523 · ClinicalTrials.gov registry record · Phase 3
GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT01589523: Completed Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01589523 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01589523, a Phase 3 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the way (mechanisms) by which your defect in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your vitamin absorption and your liver disease. An investigational therapy is one that not approved by the United States Food and Drug Administration (FDA) and is being provided to you under an Investigational New Drug application from the FDA.
Primary Outcome
This is the number of participants with bile acid amidation defects treated with oral glycocholic acid (15 milligrams/kilograms (mg/kg) of body weight/day (bw/day))
Interventions
- DRUG Glycocholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-02 |
| Est. Completion | 2019-01-22 |
| Phase | Phase 3 |
What the finished NCT01589523 record still lists
NCT01589523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Glycocholic Acid is the first listed.
NCT01589523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01589523 about?
NCT01589523 is a clinical study titled "GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis". The purpose of this research study is to determine the way (mechanisms) by which your defect in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your vitamin absorption and ...
What is the current status of trial NCT01589523?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2006-02. Estimated completion is 2019-01-22.
What interventions are being tested in trial NCT01589523?
The interventions under investigation include: Glycocholic Acid (DRUG).
Who is sponsoring clinical trial NCT01589523?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01589523's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 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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