Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kim Orchard

ORCID ID

Contact details

Haematology Department
MP 8
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes