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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2020

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At a glance

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

    • 30 Apr 2020 According to a Dova Pharmaceuticals media release, DOPTELET (avatrombopag) has been granted approval from the China National Medical Products Administration (NMPA) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure (i.e., the CLD indication).The approval was based on safety and efficacy data from two global Phase 3, double-blind, placebo-controlled trials (NCT01972529 and NCT01976104).
    • 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.
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