ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency

ClinicalTrials.gov ID: NCT03921541

Public ClinicalTrials.gov record NCT03921541. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 21, 2026, 1:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults With Arginase 1 Deficiency

Study identification

NCT ID
NCT03921541
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Aeglea Biotherapeutics
Industry
Enrollment
32 participants

Conditions and interventions

Interventions

  • Pegzilarginase Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 9, 2019
Primary completion
Jan 26, 2023
Completion
Jan 26, 2023
Last update posted
Nov 18, 2024

2019 – 2023

United States locations

U.S. sites
17
U.S. states
13
U.S. cities
17
Facility City State ZIP Site status
Harvey Pediatrics Rogers Arkansas 72758
Children's Hospital of Orange County Orange California 92868
Stanford University School of Medicine Stanford California 94305
Children's National Medical Center Washington D.C. District of Columbia 20010
University of Florida College of Medicine Gainesville Florida 32610
Emory University Atlanta Georgia 30322
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611
Icahn School of Medicine at Mount Sinai New York New York 10029
Cohen Children's Medical Center (Northwell Health) Queens New York 11040
Duke University Medical Center Durham North Carolina 27710
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15224
Vanderbilt University Medical Center Nashville Tennessee 37232
UT Southwestern Medical Center Dallas Texas 75390
University of Texas Health Science Center Medical School at Houston Houston Texas 77030
University of Utah Hospitals & Clinics Salt Lake City Utah 84108
Seattle Children's Hospital Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03921541, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 18, 2024 · Synced May 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03921541 live on ClinicalTrials.gov.

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