EUCTR2004-000592-33-SE
Active, not recruiting
Not 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 enrollmentJanuary 5, 2006
ConditionsHepatic veno-occlusive disease following hematopoietic stem cell transplantationMedDRA version: 9.1Level: LLTClassification code 10047217Term: Venoocclusive syndrome of the liverMedDRA version: 9.1Level: LLTClassification code 10047207Term: Veno-occlusive liver damage
DrugsProciclide
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatic veno-occlusive disease following hematopoietic stem cell transplantation
- Sponsor
- Gentium S.p.A
- Enrollment
- 270
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Those who do not fulfill the inclusion criteria.
- •Patients who are pregnant.
Outcomes
Primary Outcomes
Not specified
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