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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.

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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

FieldValue
Enrollment Target 32 participants
Start Date 2019-04-10
Est. Completion 2023-01-27
Phase Phase 3

Sponsor

Aeglea Biotherapeutics

7 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.