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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History