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NCT01881984 · ClinicalTrials.gov registry record · Phase 1
Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01881984 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 4 participants.
The verdict
NCT01881984, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a medical research study to test a medication in adult patients with a disease called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the 985A\>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is currently FDA approved for the treatment of urea cycle disorders. Previous research suggests that Ravicti may also be effective in the treatment MCAD deficiency. This study will investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD deficiency caused by having at least one copy of the 985A\>G mutation.
Interventions
- DRUG Ravicti
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-06 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01881984
The ClinicalTrials.gov registry entry for NCT01881984 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ravicti is the first listed.
NCT01881984 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01881984 about?
NCT01881984 is a clinical study titled "Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation". This is a medical research study to test a medication in adult patients with a disease called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the 985A\>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is currently FDA approved for the ...
What is the current status of trial NCT01881984?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2013-06. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01881984?
The interventions under investigation include: Ravicti (DRUG).
Who is sponsoring clinical trial NCT01881984?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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