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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2018

At a glance

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

    • 17 Apr 2018 According to a Rigel Pharmaceuticals media release, 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.
    • 01 Mar 2018 According to a Rigel Pharmaceuticals media release, data from this study will be presented at the 4th Biennial Summit of the Thrombosis & Hemostasis Societies of North America 2018.
    • 21 Aug 2017 Planned End Date changed from 1 Oct 2017 to 1 Apr 2018.
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