A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT00475423
- Phase
- PHASE2
- Status
- Completed
Conditions
- Idiopathic Thrombocytopenic Purpura
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab [MabThera/Rituxan] — DRUG1000mg iv on days 1 and 15
Study Details
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.
Key Dates
- Start date
- May 31, 2007
- Status verified
- Feb 2015
- Primary completion
- Aug 31, 2011
- Completion
- Aug 31, 2011
Study Design
- Enrollment
- 122 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
Primary Outcome Measure
Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) [ Time Frame: Week 8 ]