drugset / Trial / NCT00475423

A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

NCT00475423 ↗

Phase 2 Completed 122 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2007-05
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1000 mg Intravenous