A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Description
Brief Summary
The purpose of this study is to determine whether fostamatinib is safe and effective in the
treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- 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
Sites
-
California
- University of Southern California, Los Angeles, California, 90089
-
Arizona
- Arizona Oncology Associates, Tucson, Arizona, 85710
-
Utah
- University of Utah Health Sciences Center, Salt Lake City, Utah, 84132
-
Illinois
- Bleeding & Clotting Disorders Institute, Peoria, Illinois, 61614
-
Ohio
- Signal Point Clinical Research Center LLC, Middletown, Ohio, 45042
Powered by
SC CTSI