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

Roche

Status and phase: Completed; Phase 2

Conditions: Idiopathic Thrombocytopenic Purpura

Treatments: Drug: rituximab [MabThera/Rituxan]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475423

ML20948

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

1

Experimental group

Treatment:

Drug: rituximab [MabThera/Rituxan]