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)

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jan 2018

At a glance

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

    • 03 Jan 2018 According to a Dova Pharmaceuticals media release, the company anticipates submitting a sNDA for avatrombopag in the second half of 2018 based on results from this trial.
    • 12 Dec 2017 Primary endpoint has been met. (Cumulative Number Of Weeks Of Platelet Response Over 6 Months of Treatment) as per result presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 12 Dec 2017 Results presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
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