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NCT00355264 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency
A Phase 2 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00355264 is a Phase 2 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 12 participants.
The verdict
NCT00355264, a Phase 2 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the ability of Phenoptin to control blood phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4 deficiency and to evaluate the safety of Phenoptin in this population. Some subjects were receiving non-registered formulations of BH4 at enrollment and this treatment was suspended after Part 1 and within one day the subjects started Phenoptin at approximately the same dose.
Interventions
- DRUG Phenoptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-08 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00355264
The ClinicalTrials.gov registry entry for NCT00355264 describes a study currently listed as completed, 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 BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Phenoptin is the first listed.
NCT00355264 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00355264 about?
NCT00355264 is a clinical study titled "Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency". The purpose of this study is to evaluate the ability of Phenoptin to control blood phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4 deficiency and to evaluate the safety of Phenoptin in this population. Some subjects were receiving non-registered formulations of B...
What is the current status of trial NCT00355264?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2006-08. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00355264?
The interventions under investigation include: Phenoptin (DRUG).
Who is sponsoring clinical trial NCT00355264?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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