A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hematology, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | January 2015 |
| End Date: | August 2016 |
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
The purpose of this study is to determine whether fostamatinib is safe and effective in the
treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
Inclusion Criteria:
- Clinical diagnosis of persistent/chronic ITP for at least 3 months
- Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue
therapy) from at least 3 qualifying counts
Exclusion Criteria:
- Clinical diagnosis of autoimmune hemolytic anemia
- Uncontrolled or poorly controlled hypertension
- History of coagulopathy including prothrombotic conditions
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