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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: Clinical Trial Phase 2 study, sponsored by Emory University.
NCT01395394 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.
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 |
Why NCT01395394 stopped before completion
NCT01395394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Kuvan is the first listed.
NCT01395394 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01395394's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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