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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 is a Phase 3 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 5 participants.
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.
Interventions
- DRUG Glycocholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-02 |
| Est. Completion | 2019-01-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01589523
The ClinicalTrials.gov registry entry for NCT01589523 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Glycocholic Acid is the first listed.
NCT01589523 reports 0 study locations.
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.
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