deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT03339297

An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

Sponsor: Jazz Pharmaceuticals

Conditions Acute-graft-versus-host Disease Graft-versus-host Disease
Interventions Defibrotide Standard of Care
Updated 20 times since 2017 Last updated: Jul 26, 2021 Started: Feb 21, 2018 Primary completion: May 12, 2020 Completion: May 12, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Acute-graft-versus-host Disease and Graft-versus-host Disease and is currently completed. Jazz Pharmaceuticals leads this study, which shows 20 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Jun 2020 · 11 months · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

20 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE2

▶ Show 15 earlier versions

  1. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE2

  2. Aug 2020 — Sep 2020 [monthly]

    Completed PHASE2

  3. Jun 2020 — Aug 2020 [monthly]

    Completed PHASE2

    Status: Recruiting → Completed

  4. Jul 2019 — Jun 2020 [monthly]

    Recruiting PHASE2

  5. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE2

  6. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  7. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE2

  8. Dec 2018 — Apr 2019 [monthly]

    Recruiting PHASE2

  9. Oct 2018 — Dec 2018 [monthly]

    Recruiting PHASE2

  10. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE2

  11. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  12. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  13. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  14. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  15. Dec 2017 — Mar 2018 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Jazz Pharmaceuticals
Data source: Jazz Pharmaceuticals

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

Study Locations

A Coruña, Spain , Athens, Greece , Atlanta, United States , Berlin, Germany , Birmingham, United Kingdom , Bochum, Germany , Brandenburg, Germany , Brussels, Belgium , Chapel Hill, United States , Charleston, United States and 48 more locations