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A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

Trial Profile

A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 31 May 2022

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At a glance

  • Drugs Defibrotide (Primary)
  • Indications Veno-occlusive disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms HARMONY
  • Sponsors Jazz Pharmaceuticals Inc
  • Most Recent Events

    • 06 May 2022 According to an EMECA media release, In view of the findings of the study and taking the safety profile of defibrotide into account, the PRAC considers it useful to inform health care professionals that Defitelio should not be used for prophylactic treatment of VOD.
    • 14 Dec 2021 Primary endpoint (Veno-Occlusive Disease (VOD)-Free Survival at Day 30 Post-Hemotopoietic Stem Cell Transplant (HSCT)) has not been met as per results presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 14 Dec 2021 Preliminary results presented at the 63rd American Society of Hematology Annual Meeting and Exposition
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