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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2019

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At a glance

  • Drugs Fostamatinib (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Acronyms FIT2
  • Sponsors Rigel Pharmaceuticals
  • Most Recent Events

    • 05 Jun 2018 Results of a pooled analysis of NCT02076399 and NCT02076412 assessing responses by prior therapy and baseline platelet count, presented at the 54th Annual Meeting of the American Society of Clinical Oncology
    • 30 Apr 2018 According to a Rigel Pharmaceuticals media release, data from this trial has been published in American Journal of Hematology.
    • 17 Apr 2018 According to a Rigel Pharmaceuticals media release, based on the data from the Phase 3 clinical program [Study 047, 048 and 049] the U.S. FDA has approved TAVALISSE (fostamatinib disodium) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia. Together with an initial proof of concept study, the NDA included 163 ITP patients.
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