Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272948
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2006-01-04
Brief Title:
Pediatric Trial Investigating the Incidence Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide
Sponsor:
European Society for Blood and Marrow Transplantation
Organization:
European Society for Blood and Marrow Transplantation
Study Overview
Official Title:
Prospective Randomized Study of the Incidence and Outcome of Veno-Occlusive Disease VOD With the Prophylactic Use of Defibrotide DF in Pediatric Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VOD-DF
Brief Summary:
The aim of this trial is to evaluate whether the prophylactic use of Defibrotide DF in pediatric patients age less than 18 years undergoing stem cell transplantation and who are at high risk of developing hepatic Veno-occlusive Disease VOD will have an impact on the incidence and severity of the disease Patients will be randomly assigned to one of two treatment arms Those allocated to the Prophylactic Arm will receive the study drug Defibrotide from the day of conditioning onwards Patients allocated to the Control Arm will receive the study drug Defibrotide from the day that VOD is diagnosed
Detailed Description:
Comparisoncontrol intervention and duration of the intervention
Patients will be assigned randomly to either the Defibrotide DF prophylaxis arm or the control arm Those allocated to the DF prophylaxis arm DF 25 mgkgd iv in 4 doses will begin treatment at day of conditioning and stop at day 30 after Stem Cell Transplantation SCT or upon discharge from inpatient care There is no dose adjustment for a patient of the study arm who developed VOD they continue with the 25mgkgd iv
Patients allocated to the control arm receive no prophylactic measures and will start DF 25 mgkgd iv in 4 doses beginning at day of diagnosis of Veno-occlusive Disease VOD according to modified Seattle criteria Treatment will be stopped at complete resolution of symptoms In both arms patients who developed VOD will continue DF until
complete resolution of the ascites and
reversion of the hepatopedal flow if present and
normalization of the total and direct bilirubin
Patients will be assigned randomly to either the Defibrotide DF prophylaxis arm or the control arm Those allocated to the DF prophylaxis arm DF 25 mgkgd iv in 4 doses will begin treatment at day of conditioning and stop at day 30 after Stem Cell Transplantation SCT or upon discharge from inpatient care There is no dose adjustment for a patient of the study arm who developed VOD they continue with the 25mgkgd iv
Patients allocated to the control arm receive no prophylactic measures and will start DF 25 mgkgd iv in 4 doses beginning at day of diagnosis of Veno-occlusive Disease VOD according to modified Seattle criteria Treatment will be stopped at complete resolution of symptoms In both arms patients who developed VOD will continue DF until
complete resolution of the ascites and
reversion of the hepatopedal flow if present and
normalization of the total and direct bilirubin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EBMT-PD-200601 | None | None | None |