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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenia Purpura)

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenia Purpura)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jul 2021

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At a glance

  • Drugs Avatrombopag (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Sponsors Eisai Inc
  • Most Recent Events

    • 06 Jul 2021 According to a Swedish Orphan Biovitrum media release, results from the study will be presented at the virtual ISTH 2021, the 29th Congress of the International Society on Thrombosis and Haemostasis.
    • 17 Jun 2021 Results of a post hoc analysis of core and extension study assessing the durability of response over time utilizing clinically relevant loss of response presented at the 26th Congress of the European Haematology Association
    • 08 Dec 2020 Results of a pooled analysis assessing the efficacy profile of AVA across its clinical development program (comprised of 4 phase 2 and 3 studies, CL-003,CL-004, study 302 and study 305), presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
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