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NCT00925054 · ClinicalTrials.gov registry record · Phase 2
Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU
A Phase 2 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00925054 is a Phase 2 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 40 participants.
The verdict
NCT00925054, a Phase 2 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether repeated administration is safe.
Interventions
- DRUG rAvPAL-PEG 0.001 mg/kg
- DRUG rAvPAL-PEG 0.003 mg/kg
- DRUG rAvPAL-PEG 0.01 mg/kg
- DRUG rAvPAL-PEG 0.03 mg/kg
- DRUG rAvPAL-PEG 0.1 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-09 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00925054
The ClinicalTrials.gov registry entry for NCT00925054 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 5 interventions - of which rAvPAL-PEG 0.001 mg/kg is the first listed.
NCT00925054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00925054 about?
NCT00925054 is a clinical study titled "Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU". The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether repeated administration is safe.
What is the current status of trial NCT00925054?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2009-09. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00925054?
The interventions under investigation include: rAvPAL-PEG 0.001 mg/kg (DRUG), rAvPAL-PEG 0.003 mg/kg (DRUG), rAvPAL-PEG 0.01 mg/kg (DRUG), rAvPAL-PEG 0.03 mg/kg (DRUG), rAvPAL-PEG 0.1 mg/kg (DRUG).
Who is sponsoring clinical trial NCT00925054?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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