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Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoietic Stem Cell Transplant Patients: A Historically-Controlled, Multi-Center Phase 3 Study to Determine Safety and Efficacy.

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Trial Profile

Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoietic Stem Cell Transplant Patients: A Historically-Controlled, Multi-Center Phase 3 Study to Determine Safety and Efficacy.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2021

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At a glance

  • Drugs Defibrotide (Primary)
  • Indications Hepatic veno-occlusive disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Gentium; Jazz Pharmaceuticals plc

    • Most Recent Events

    • 30 Mar 2016 According to a media release, the US FDA has approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT).
    • 29 Jan 2016 Results published in the Blood
    • 08 Dec 2015 Results presented at the 57th Annual Meeting and Exposition of the American Society of Hematology.

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