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A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Trial Profile

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Fostamatinib (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FIT; FIT3; HAEM 3426
  • Sponsors Rigel Pharmaceuticals
  • Most Recent Events

    • 02 Nov 2023 According to a Rigel Pharmaceuticals media release, long-term efficacy and safety of fostamatinib in Japanese patients will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually.
    • 23 Dec 2022 According to a Kissei Pharmaceutical media release, based on the results of the Phase 3 clinical trials of TAVALISSE in ITP patients in Japan and outside of Japan, the Ministry of Health, Labour and Welfare (MHLW) has granted manufacturing and marketing approval for the oral spleen tyrosine kinase inhibitor, TAVALISSE (Tab. 100mg and 150mg (generic name: fostamatinib disodium hexahydrate)), for chronic idiopathic thrombocytopenic purpura (chronic ITP).
    • 14 Jul 2021 Post hoc analysis of the FIT Phase 3 program published in the Rigel Pharmaceuticals Media Release.
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