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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Thrombocytopenic Purpura

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

1000mg iv on days 1 and 15

Interventions

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rituximab [MabThera/Rituxan]

1000mg iv on days 1 and 15

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No