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Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide

NCT00272948 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2011-06-09

No results posted yet for this study

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.

Conditions

  • Hepatic Veno-Occlusive Disease

Interventions

DRUG

Defibrotide

Defibrotide 25 mg/kg/d

DRUG

Defibrotide

Defibrotide 25 mg/kg/d iv in 4 doses beginning at day of conditioning until day +30 or until discharge from inpatient care (with a minimum treatment of 14 days) if VOD does not occur.

DRUG

Defibrotide

Defibrotide 25 mg/kg/d iv therapeutically when patients fulfil modified Seattle criteria

Sponsors & Collaborators

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Selim Corbacioglu, MD · University of Ulm, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-01-31
Completion
2009-07-31

Countries

  • Austria
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00272948 on ClinicalTrials.gov