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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)

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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: 24 Apr 2023

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At a glance

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

    • Most Recent Events

    • 04 Apr 2023 Results of post hoc analysis evaluated platelet count response to avatrombopag during the core study in different subgroups, and durability of response data in patients who responded to avatrombopag treatment both during the core phase and during the core and extension phase, published in the Platelets.
    • 17 Feb 2022 Results of this post-hoc analysis assessing efficacy and safety evaluation of avatrombopag in immune thrombocytopenia published in the Platelets
    • 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.
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