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NC-HEM-14-2: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Description

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
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