A Phase 3, 2-Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are 2 Through 5 Years of Age and Have a CFTR Gating Mutation

Trial Profile

A Phase 3, 2-Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are 2 Through 5 Years of Age and Have a CFTR Gating Mutation

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2016

At a glance

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

    • 27 Oct 2016 Results presented at the 30th Annual North American Cystic Fibrosis Conference (NACFC), as per Vertex Pharmaceuticals media release.
    • 27 Oct 2016 Results published in Vertex Pharmaceuticals media release.
    • 18 Nov 2015 According to a Vertex Pharmaceuticals media release, the US FDA has approved expansion of the indication for ivacaftor [KALYDECO] to include children of ages 2 to 5 with cystic fibrosis who have one of nine gating mutations in CFTR gene. The approval was based on results from this trial.
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