A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR Mutation

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR Mutation

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2015

At a glance

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

    • 18 Nov 2015 According to a vertex Pharmaceutical media release, the European Commission has approved expanded use of ivacaftor (KALYDECO) in patients with cystic fibrosis ages 18 and older who have the R117H mutation. The approval was based on the results from this trial.
    • 08 Oct 2015 According to a vertex Pharmaceutical media release, the EU Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending KALYDECO for use in patients with CF ages 18 and older who have the R117H mutation.
    • 30 Jun 2014 Results published in the Media Release.
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