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NCT01395394 · ClinicalTrials.gov registry record · Phase 2
Phenylketonuria, Oxidative Stress, and BH4
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01395394 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 12 participants.
The verdict
NCT01395394, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial function in patients with Phenylketonuria (PKU).
Interventions
- DRUG Kuvan
- OTHER Meal Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01395394
The ClinicalTrials.gov registry entry for NCT01395394 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Kuvan is the first listed.
NCT01395394 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01395394 about?
NCT01395394 is a clinical study titled "Phenylketonuria, Oxidative Stress, and BH4". The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial function in patients with Phenylketonuria (PKU).
What is the current status of trial NCT01395394?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01395394?
The interventions under investigation include: Kuvan (DRUG), Meal Challenge (OTHER).
Who is sponsoring clinical trial NCT01395394?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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