deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03921541

Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency

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

Sponsor: Aeglea Biotherapeutics

Conditions Arginase I Deficiency Hyperargininemia
Interventions Pegzilarginase Placebo
Updated 26 times since 2019 Last updated: Nov 13, 2024 Started: Apr 10, 2019 Primary completion: Jan 27, 2023 Completion: Jan 27, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Arginase I Deficiency and Hyperargininemia, this trial is completed. The trial is conducted by Aeglea Biotherapeutics and has accumulated 26 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~Jul 2020 · 3 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Nov 2021 · 5 months · monthly snapshot~Nov 2021 – ~Mar 2022 · 4 months · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Sep 2022 · 4 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Aug 2023 · 7 months · monthly snapshot~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

26 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Dec 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Dec 2024 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

▶ Show 21 earlier versions

  1. Jan 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE3

  3. May 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  4. Apr 2022 — May 2022 [monthly]

    Active Not Recruiting PHASE3

  5. Mar 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE3

  6. Nov 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE3

  7. Jun 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  8. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  9. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  10. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  11. Jul 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  12. Apr 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  13. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  14. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  15. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  16. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  17. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  18. Sep 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  19. Jul 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  20. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  21. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Aeglea Biotherapeutics
Data source: Aeglea Biotherapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Birmingham, United Kingdom , Bregenz, Austria , Cardiff, United Kingdom , Chicago, United States , Dallas, United States , Durham, United States , Gainesville, United States , Houston, United States , Innsbruck, Austria and 22 more locations