NCT00475423

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

An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	rituximab [MabThera/Rituxan]	1000mg iv on days 1 and 15

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2007-05-21
• Last updated: 2015-02-23
• Results posted: 2015-02-23

Locations

12 sites across 1 country: Australia