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NCT03921541 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency
A Phase 3 study, sponsored by Aeglea Biotherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT03921541 is a Phase 3 study that has completed, run by Aeglea Biotherapeutics. The registered enrollment target is 32 participants.
The verdict
NCT03921541, a Phase 3 study, has completed, sponsored by Aeglea Biotherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.
Interventions
- DRUG Placebo
- DRUG Pegzilarginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2023-01-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03921541
The ClinicalTrials.gov registry entry for NCT03921541 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aeglea Biotherapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03921541 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03921541 about?
NCT03921541 is a clinical study titled "Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency". CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit f...
What is the current status of trial NCT03921541?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2019-04-10. Estimated completion is 2023-01-27.
What interventions are being tested in trial NCT03921541?
The interventions under investigation include: Placebo (DRUG), Pegzilarginase (DRUG).
Who is sponsoring clinical trial NCT03921541?
This trial is sponsored by Aeglea Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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