Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
The aim of this trial is to evaluate whether the prophylactic use of Defibrotide (DF) in
pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are
at high risk of developing hepatic Veno-occlusive Disease (VOD) will have an impact on the
incidence and severity of the disease. Patients will be randomly assigned to one of two
treatment arms: Those allocated to the Prophylactic Arm will receive the study drug
(Defibrotide) from the day of conditioning onwards. Patients allocated to the Control Arm
will receive the study drug (Defibrotide) from the day that VOD is diagnosed.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
European Group for Blood and Marrow Transplantation European Society for Blood and Marrow Transplantation
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany) Jazz Pharmaceuticals