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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• refractory, relapsing or chronic idiopathic thrombocytopenic purpura;

• stable therapy during 3 weeks prior to study entry.

Exclusion Criteria:

• newly diagnosed ITP (<6 weeks);

• prior treatment with MabThera;

• active bleeding requiring platelet transfusion within 7 days prior to entry into study.