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NCT01115582 · ClinicalTrials.gov registry record · Phase 3
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
A Phase 3 study, sponsored by Mirum Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT01115582 is a Phase 3 study that has completed, run by Mirum Pharmaceuticals. The registered enrollment target is 16 participants.
The verdict
NCT01115582, a Phase 3 study, has completed, sponsored by Mirum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to compare the efficacy of these currently used capsules with the efficacy of the same treatment provided in a cholic acid capsule that is made by a company that will be marketed after FDA approval. At baseline, patients receive established doses of cholic acid capsules prepared at the Cincinnati Children's Hospital Medical Center Pharmacy. During the study, patients receive the same treatment provided in the to-be-marketed (TBM) cholic acid capsule. Hence, patients serve as their own controls, with baseline values presenting the reference value (CCHMC cholic acid capsule) and values after 30 days treatment presenting the value for the investigational treatment (TBM cholic acid capsule).
Interventions
- DRUG Cholic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01115582
The ClinicalTrials.gov registry entry for NCT01115582 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cholic acid is the first listed.
NCT01115582 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01115582 about?
NCT01115582 is a clinical study titled "Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis". This is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital Pharmacy. The study is designed to compare the efficacy of these curren...
What is the current status of trial NCT01115582?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2010-04. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01115582?
The interventions under investigation include: Cholic acid (DRUG).
Who is sponsoring clinical trial NCT01115582?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
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