A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

Trial Profile

A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Avatrombopag (Primary)
  • Indications Thrombocytopenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ADAPT II
  • Sponsors Dova Pharmaceuticals; Eisai Inc
  • Most Recent Events

    • 04 Dec 2017 According to a Dova Pharmaceuticals media release, data from the study will be presented at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition.
    • 27 Nov 2017 According to a Dova Pharmaceuticals media release, the NDA for avatrombopag has been accepted for filing and has been granted Priority Review by the United States Food and Drug Administration (FDA). The submission is based on ADAPT 1 and ADAPT 2 trials. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is May 21, 2018.
    • 24 Oct 2017 Results from ADAPT 1 and ADAPT 2 studies, presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
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