EUCTR2004-000592-33-CZActive, not recruitingNot Applicable
Prospective Study of the Incidence and Outcome of Venoocclusive Disease (VOD) with the Prophylactic Use of Defibrotide (DF, Gentium, Italy) in Pediatric Stem Cell Transplantation - VOD-DF Study
Gentium S.p.A0 sites270 target enrollmentStarted: November 8, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 270
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients < 18 years who have myeloablative conditioning and at least one of the following risk factors:
- •Children having a second myeloablative stem cell transplant
- •Allogeneic stem cell transplants for leukaemia >2 relapses
- •Liver disease
- •History of treatment with gemtuzumab ozogamicin (Mylotarg)
- •Conditioning with busulfan and melphalan
- •Osteopetrosis
- •Macrophage activating syndromes
- •Adrenoleukodystrophy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Those who do not fulfill the inclusion criteria.
- •Patients who are pregnant.
Investigators
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