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Prospective study of the incidence and outcome of Veno-occlusive disease (VOD)with the prophylactic use of Defibrotide (DF, Gentium, Italy) in pediatric stem cell transplantation

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Trial Profile

Prospective study of the incidence and outcome of Veno-occlusive disease (VOD)with the prophylactic use of Defibrotide (DF, Gentium, Italy) in pediatric stem cell transplantation

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 29 Sep 2021

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At a glance

  • Drugs Defibrotide (Primary)
  • Indications Embolism and thrombosis; Veno-occlusive disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms VOD-DF
  • Sponsors Gentium

    • Most Recent Events

    • 30 Sep 2015 According to a Jazz Pharmaceuticals media release, the U.S. FDA has accepted for filing with Priority Review its recently submitted NDA for defibrotide for the treatment of patients with hepatic veno-occlusive disease.
    • 06 Jun 2011 Results from this trial were used, in part, to support an NDA application for defibrotide in the US.
    • 14 Sep 2010 Results on the prevention of graft-versus-host-disease (secondary endpoint) will be presented at the 33rd World Congress of International Society of Hematology, according to a Gentium media release.

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