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A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Trial Profile

A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jan 2018

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At a glance

  • Drugs Ivacaftor (Primary) ; Ivacaftor/lumacaftor (Primary) ; Lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 10 Jan 2018 According to a Vertex Pharmaceuticals media release, based on the data from this and another phase III trial, the European Commission has granted extension of the Marketing Authorization for ORKAMBI (lumacaftor/ivacaftor), to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, to include children ages 6 through 11.
    • 02 Nov 2016 Results of Part B assessing assessing safety and tolerability published in the American Journal of Respiratory and Critical Care Medicine
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