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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000468-26-IT
Enrollment
Unknown
Registered
2007-05-10
Start date
2007-01-11
Completion date
Unknown
Last updated
2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NOT AVAILABLE MedDRA version: 9.1 Level: LLT Classification code 10015108 Term: Epstein-Barr virus infection

Interventions

Trade Name: MABTHERA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: evidence of sistemic infection, known ipersensibilities to rituximab, ...

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026