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NCT03694353 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 37
- Enrollment target
NCT03694353 is a Phase 3 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 37 participants.
The verdict
NCT03694353, a Phase 3 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 37 participants
- Enrollment target
Study Summary
This is a Phase 3 open-label extension study enrolling adult patients with PKU who were previously treated with pegvaliase in Studies PAL-003 (NCT00924703) or 165-302 (NCT02468570). The study is designed to evaluate the long-term safety and efficacy of pegvaliase administered at doses \> 40 mg/day to 60 mg/day.
Interventions
- DRUG Pegvaliase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-09-13 |
| Est. Completion | 2021-01-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03694353
The ClinicalTrials.gov registry entry for NCT03694353 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 37 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 Pegvaliase is the first listed.
NCT03694353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03694353 about?
NCT03694353 is a clinical study titled "Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU". This is a Phase 3 open-label extension study enrolling adult patients with PKU who were previously treated with pegvaliase in Studies PAL-003 (NCT00924703) or 165-302 (NCT02468570). The study is designed to evaluate the long-term safety and efficacy of pegvaliase administered at doses \> 40 mg/day t...
What is the current status of trial NCT03694353?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 37 participants. The study started on 2018-09-13. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT03694353?
The interventions under investigation include: Pegvaliase (DRUG).
Who is sponsoring clinical trial NCT03694353?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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