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Prospective study of the incidence and outcome of Veno-occlusive disease (VOD)with the prophylactic use of Defibrotide (DF, Gentium, Italy) in pediatric stem cell transplantatio

Conditions
Prevention of hepatic veno-occlusive disease in pediatric patients at high risk of VOD
MedDRA version: 14.1Level: PTClassification code 10047216Term: Venoocclusive liver diseaseSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2004-000592-33-IT
Lead Sponsor
GENTIUM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
360
Inclusion Criteria

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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

Not provided

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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