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 |
| Protocol serial number | N0231120099 |
| Sponsor | Department of Health (UK) |
| Funder | Southampton University Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Defibrotide |
| Primary outcome measure(s) |
Survival at 7, 14, 30, 60 and 100 days after diagnosis. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
