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A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

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

    • Most Recent Events

    • 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
    • 04 Dec 2018 Results assessing the preclinical findings and screen for atrophic gastritis, gastric biomarkers (gastrin, gastrin-17, and pepsinogen I/II [PG-I/PG-II]) from 2 Phase 3 trials (NCT01438840 and NCT01433978) presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 08 Apr 2016 Treatment arms changed from 2 to 3 with addition of Open-label Extension.
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