A phase I/II multicentre study to evaluate the safety and efficacy of rituximab (monoclonal antibody anti-CD20) for prevention and/or therapy of EBV-disease. - ND
- Conditions
- OT AVAILABLEMedDRA version: 9.1Level: LLTClassification code 10015108Term: Epstein-Barr virus infection
- Registration Number
- EUCTR2007-000468-26-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
age < 18; patients receiving stem cell transplantation or organ transplantation and patiets with primitive immunodeficiency
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
evidence of sistemic infection, known ipersensibilities to rituximab, ...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate safety and efficacy of rituximab for prevention and/or therapy of EBV-disease;Secondary Objective: to evaluate the pharmacokinetic profile of rituximab in paediatric popolation;Primary end point(s): PTLD incidence
- Secondary Outcome Measures
Name Time Method