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

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

Completed
Phase of Trial: Phase II/III

Latest Information Update: 30 Sep 2015

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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top