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A multi-centre, multinational, prospective observational registry to collect safety and outcome data in patients diagnosed with severe hepatic VOD following hematopoietic stem cell transplantation (HSCT) and treated with Defitelio® or supportive care (control group)

Transplant Complications Working Party (TCWP)
Study number:
DF VOD-2013-03-REG
Type of transplant:
Allogeneic
Diseases:
Complications: non-infectious
Short title:
VOD REGISTRY
Study status:
COLLECTING DATA, NOT RECRUITING
Deadline for data collection:
Study design:
Prospective, multinational study - 2 cohorts (under defibrotide/ under supportive care)
Primary objective:
The main objective of the registry is to assess the incidence rate of specific SAEs of interest (including fatalities) in patients with severe hepatic VOD treated with Defitelio® and to compare these rates with those occurring in a similar population not treated with Defitelio®.
Key inclusion criteria:
- Any consenting patient with a diagnosis of severe VOD post-HSCT (treated with defibrotide or under supportive care)
- Any consenting patient receiving defibrotide for any other condition (VOD Prophylaxis, non-severe VOD…) in HSCT context
Country:
France
Italy
Portugal
United Kingdom
Principal investigator:
Pr Mohamad Mohty
Principal investigator email:
 
EBMT Study coordinator:
Jessica Lemaitre
Study coordinator email:
jessica.lemaitre@upmc.fr

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