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NCT03378531 · ClinicalTrials.gov registry record · Phase 2

A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency

A Phase 2 study of Hyperargininemia and Arginase I Deficiency, sponsored by Aeglea Biotherapeutics.

Completed
Registry status
Phase 2
Development phase
14
Enrollment target
7
Study locations

NCT03378531 is a Phase 2 study of Hyperargininemia and Arginase I Deficiency that has completed, run by Aeglea Biotherapeutics. The registered enrollment target is 14 participants. The trial reports 7 study locations across 6 states.

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The verdict

NCT03378531, a Phase 2 study of Hyperargininemia and Arginase I Deficiency, has completed, sponsored by Aeglea Biotherapeutics.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target
7
Study locations

Study Summary

The purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.

Interventions

  • DRUG AEB1102

Study Locations (7)

Other

  • Centro Hospitalar S. Joao - Porto
  • Great Ormond Street Hospital - London

California

  • Stanford University School of Medicine - Stanford

Florida

  • University of Florida - Gainesville

New York

  • Icahn School of Medicine at Mount Sinai - New York

Texas

  • UTSW - Dallas

Ontario

  • The Hospital for Sick Children - Toronto

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2017-12-07
Est. Completion 2022-12-15
Phase Phase 2

Sponsor

Aeglea Biotherapeutics

7 total trials

What the Registry Record Tells You About NCT03378531

The ClinicalTrials.gov registry entry for NCT03378531 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 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 2 conditions, with Hyperargininemia appearing as the primary indexed condition, and to 1 intervention - of which AEB1102 is the first listed.

NCT03378531 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT03378531 about?

NCT03378531 is a clinical study titled "A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency". The purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.

What is the current status of trial NCT03378531?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2017-12-07. Estimated completion is 2022-12-15.

What conditions does trial NCT03378531 study?

This clinical trial studies the following conditions: Hyperargininemia, Arginase I Deficiency.

What interventions are being tested in trial NCT03378531?

The interventions under investigation include: AEB1102 (DRUG).

Who is sponsoring clinical trial NCT03378531?

This trial is sponsored by Aeglea Biotherapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03378531 being conducted?

This trial has 7 study locations across California, Florida, New York, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.