A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of AMG 531 in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura

Trial Profile

A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of AMG 531 in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura

Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Nov 2017

At a glance

  • Drugs Romiplostim (Primary)
  • Indications Immune thrombocytopenic purpura; Thrombocytopenia
  • Focus Adverse reactions
  • Sponsors Amgen
  • Most Recent Events

    • 10 Nov 2017 According to an amgen media release, The CHMP of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for Nplate (romiplostim) to include the treatment of idiopathic thrombocytopenic purpura for patients one year of age and older.CHMP opinion was based on five studies including 4 completed studies (a Phase 3, a Phase 1/2 placebo-controlled study, two long-term safetyand efficacy studies) and one ongoing long-term safety and efficacy study.
    • 04 Jul 2014 New trial record
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