A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: BB 1101; Chlorpheniramine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Rituximab

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• untreated ITP.

Exclusion Criteria:

• ITP with relapse;

• positive test result for HIV or hepatitis B or C;

• active infection requiring systemic therapy;

• malignancy within 3 years before study.