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

Study number:

DF VOD-2013-03-REG

Short title:

VOD REGISTRY

Study status:

CLOSED

Deadline for data collection:

Mon, 07/01/2019 - 12:00

Study design:

Prospective, multinational study - 1 cohort (under defibrotide)

Primary objective:

The main objective of the registry is to assess the incidence rate of specific serious adverse events (SAEs) of interest (including fatalities) in patients with severe hepatic VOD post-HSCT treated with Defitelio®

Key inclusion criteria:

- Any consenting patient with a diagnosis of severe VOD post-HSCT (treated with defibrotide)
- 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