deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02891837

L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects

A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Subjects Undergoing Surgery for Congenital Heart Defects

Sponsor: Asklepion Pharmaceuticals, LLC

Conditions Acute Lung Injury
Interventions L-citrulline Placebo
Updated 27 times since 2017 Last updated: Jan 27, 2023 Started: Aug 31, 2016 Primary completion: Jun 30, 2019 Completion: Jul 31, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02891837, this PHASE3 trial focuses on Acute Lung Injury and remains completed. Sponsored by Asklepion Pharmaceuticals, LLC, it has been updated 27 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~May 2017 · 30 days · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Nov 2017 · 31 days · monthly snapshot~Nov 2017 – ~Jan 2018 · 2 months · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jul 2019 · 3 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Feb 2020 · 6 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Mar 2023 · 26 months · monthly snapshot~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

27 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Mar 2023 [monthly]

    Completed PHASE3

▶ Show 22 earlier versions

  1. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Aug 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  3. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  4. Apr 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  5. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  6. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  7. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  8. Nov 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  9. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  10. Jun 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  11. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  12. Mar 2018 — May 2018 [monthly]

    Recruiting PHASE3

  13. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE3

  14. Jan 2018 — Feb 2018 [monthly]

    Recruiting PHASE3

  15. Nov 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  16. Oct 2017 — Nov 2017 [monthly]

    Recruiting PHASE3

  17. Aug 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  18. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  19. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  20. Apr 2017 — May 2017 [monthly]

    Recruiting PHASE3

  21. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  22. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Aug 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Asklepion Pharmaceuticals, LLC
Data source: Asklepion Pharmaceuticals, LLC

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

Study Locations

Aurora, United States , Baltimore, United States , Birmingham, United States , Cincinnati, United States , Columbus, United States , Graz, Austria , Göttingen, Germany , Haifa, Israel , Hanover, Germany , Holon, Israel and 18 more locations