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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: 27 Jun 2019

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At a glance

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

    • 27 Jun 2019 According to an Dova Pharmaceuticals media release, the company will host a conference call to discuss the approval by FDA.
    • 27 Jun 2019 According to an Dova Pharmaceuticals media release, the U.S. Food and Drug Administration(FDA) has approved a supplemental New Drug Application(sNDA) that expands the use of DOPTELET(avatrombopag) to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
    • 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
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