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.
Phase of Trial: Phase III
Latest Information Update: 03 Feb 2017
At a glance
- Drugs Defibrotide (Primary)
- Indications Embolism and thrombosis; Veno-occlusive disorders
- Focus Registrational; Therapeutic Use
- Sponsors Gentium; Jazz Pharmaceuticals plc
- 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.