A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation

Trial Profile

A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Dec 2014

At a glance

  • Drugs Ivacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms KONNECTION
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 30 Jul 2014 According to a Vertex Pharmaceuticals media release, CHMP has given positive opinion for approval of ivacftor in treating cystic fibrosis in patients of who have one of the 8 non-G551D gating mutations.
    • 27 Jun 2014 Results (part two of the trial) presented at the European Cystic Fibrosis Society Conference in June 2014.
    • 27 Jun 2014 Results (Part one of the trial) published in the Vertex Pharmaceuticals Media Release.
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