drugset / Trial / NCT01713738
Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Phase 1/2
Completed
36 enrolled
Neufeld, Ellis J, MD, PhD
Biogen · collabGenentech, Inc. · collabGlaser Pediatric Research Network · collabTerrana ITP Research Fund · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the safety and efficacy of rituximab in children ages 18 months to 18 years, who have severe, chronic ITP. Eligible patients with either primary or secondary ITP are treated with rituximab once a week for 4 doses, and then followed for up to one year. Response is defined as having a platelet count greater than or equal to 50,000/mL on four consecutive weekly measures beginning anytime in weeks 9 - 12.
Timeline
- Start
- 2003-05
- Primary completion
- 2005-12
- Completion
- 2005-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |