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
| ISRCTN | ISRCTN65464501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65464501 |
| Secondary identifying numbers | N0231120099 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kim Orchard
Scientific
Scientific
Haematology Department, MP 8
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2003 |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | All patients with diagnosis of VOD after a stem cell transplant. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 01/02/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Southampton University Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
