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

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2017

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

    • 02 Nov 2016 Results of Part B assessing assessing safety and tolerability published in the American Journal of Respiratory and Critical Care Medicine
    • 28 Sep 2016 Data from this trial will be presented at the 30th Annual North American Cystic Fibrosis Conference, as per Vertex media release.
    • 28 Sep 2016 According to Vertex media release, the U.S. Food and Drug Administration (FDA) approved ORKAMBI (lumacaftor/ivacaftor) for use in children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation.
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