Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)
- Sponsor
- Hamilton Health Sciences Corporation
- Study ID
- NCT00372892
- Phase
- PHASE2
- Status
- Completed
Conditions
- Purpura, Thrombocytopenic, Idiopathic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUG375mg/m2 per week for 4 consecutive weeks
- Placebo — DRUGSaline IV placebo once per week for 4 consecutive weeks
Study Details
The purpose of this study is to assess the feasibility of a randomized, double blind, placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purpura (ITP).
Key Dates
- Start date
- Sep 30, 2006
- Status verified
- Jun 2012
- Primary completion
- Dec 31, 2010
- Completion
- Jun 30, 2011
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: ARituximab
- Placebo Comparator: BSaline placebo iv infusion
Primary Outcome Measure
Feasibility of recruitment [ Time Frame: 3 years ]