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

• Conditions: Hepatic veno-occlusive disease following hematopoietic stem cell transplantation; MedDRA version: 9.1Level: LLTClassification code 10047217Term: Venoocclusive syndrome of the liver; MedDRA version: 9.1Level: LLTClassification code 10047207Term: Veno-occlusive liver damage

• Registration Number: EUCTR2004-000592-33-CZ
• Lead Sponsor: Gentium S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-08
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified