| DEC-NET Serial number GB513 |
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| Published online | 07/11/2005 10.20.00 |
| Last updated | 22/11/2005 13.08.25 |
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| Current trial status | Planned (i.e. not yet recruiting participants) |
First subject enrolment
Target N. of subjects |
01/2006
20 |
Major Disease
(ICD9 class) | Budd-Chiari syndrome; Hepatic vein thrombosis |
| Experimental drug |
DEFIBROTIDE
Treatment regimen (dosage and duration)
25mg/kg daily for 4 weeks. Please note this drug is given in addition to the standard treatment. |
| Gender | Both |
| Age (range) | less than 18 years |
Eligibility criteria |
| Inclusion criteria |
| Children at high risk from veno-occlusive disease |
| Exclusion criteria |
| Pregnant patients and those who are not at high risk from veno-occlusive disease |
Trial design/methodology |
| Phase | 3 |
| Kind of study | Prophylaxis
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| Design | Controlled
Randomised
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| Purpose of study |
| To determine the clinical benefit of prophylactic use of Defibrotide to prevent or reduce the severity of VOD in paediatric patients at high risk from VOD |
| Primary outcomes |
| The primary efficacy endpoint for this study is a score especially defined for this study, taking into account the development of VOD up to day +30, the severity of VOD associated MOF and the survival/death up to day+180. The lower the score the better the outcome |
| Secondary outcomes |
| none given |
| Summary of study design, objectives, and ongoing research findings |
| Randomised controlled trial - Random allocation (A) standard therapy and (B) standard therapy and defibrotide. |
