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
Active, not recruiting
- Conditions
- Prevention of hepatic veno-occlusive disease in pediatric patients at high risk of VODMedDRA version: 14.1Level: PTClassification code 10047216Term: Venoocclusive liver diseaseSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic 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
- Not 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
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Defibrotide's prophylactic efficacy against hepatic veno-occlusive disease in pediatric stem cell transplantation?
How does Defibrotide compare to standard-of-care treatments for VOD prevention in high-risk pediatric hematopoietic stem cell recipients?
What biomarkers are associated with response to Defibrotide in pediatric patients undergoing stem cell transplantation?
What are the known adverse events and management strategies for Defibrotide use in pediatric VOD prophylaxis?
Are there combination therapies or alternative compounds to Defibrotide for preventing Venoocclusive liver disease in pediatric stem cell transplantation?