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A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)

Trial Profile

A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2019

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At a glance

  • Drugs Romiplostim (Primary)
  • Indications Idiopathic thrombocytopenic purpura; Thrombocytopenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen
  • Most Recent Events

    • 14 Dec 2018 According to an Amgen media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy, based on the results of two placebo-controlled studies- Phase 3 and Phase 1/2.
    • 19 Apr 2016 Results published in an Amgen media release.
    • 18 Apr 2016 Results published in the Lancet.
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