Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0231120099
Study information
Scientific title
A multi-centre, phase II-III randomised clinical trial and observational study of defibrotide for the treatment of hepatic veno-occlusive disease after stem cell transplant
Acronym
Study hypothesis
Test the efficacy of defibrotide in the survival of patients for whom a diagnosis of veno-occlusive disease (VOD) is formulated and documented according to well predefined criteria.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hepatic veno-occlusive disease (VOD)
Intervention
Randomised phase II-III multi-centre study of defibrotide in hepatic veno-occlusive disease after stem cell transplant.
Intervention type
Drug
Phase
Not Applicable
Drug names
Defibrotide
Primary outcome measure
Survival at 7, 14, 30, 60 and 100 days after diagnosis.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2003
Overall trial end date
01/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients with diagnosis of VOD after a stem cell transplant.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2003
Recruitment end date
01/02/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southampton University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list