EBMT VOD Registry Programme
Research type
Research Study
Full title
A multi-centre, multinational, prospective observational registry to collect safety and outcome data in patients diagnosed with severe hepatic veno-occlusive disease (VOD) following haematopoietic stem cell transplantation (HSCT) and treated with Defitelio®
IRAS ID
169204
Contact name
Andrew Gennery
Contact email
Sponsor organisation
European Society for Blood and Marrow Transplantation
Duration of Study in the UK
3 years, 1 months, 19 days
Research summary
Following the licencing of a new drug,defibrotide, to treat veno-occlusive disease, a rare but serious complication of haematopoietic stem cell transplantation, the pharmaceutical company that manufactures defibrotide (Gentium Pharmaceuticals) is required to perform a Post Authorization Safety Study (PASS), which is being co-ordinated through the European Society for Blood and Marrow Transplantation. Following appropriate consent, data from patients who undergo haematopoietic stem cell transplantation are routinely collected at the local centre for the EBMT database. For this study, we are being asked to collect additional anonymised clinical and laboratory data from patients who develop this complication. The study simply requires collection of data which is already recorded, but not routinely collected. The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0232
Date of REC Opinion
30 Jun 2015
REC opinion
Favourable Opinion