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A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Trial Profile

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2018

At a glance

  • Drugs Ivacaftor/tezacaftor/VX-659 (Primary) ; Ivacaftor; Ivacaftor/tezacaftor
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 03 Dec 2018 Status changed from active, no longer recruiting to completed.
    • 27 Nov 2018 Results presented in a Vertex Pharmaceuticals media release.
    • 27 Nov 2018 Primary endpoint has been met. (Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1)), according to a Vertex Pharmaceuticals media release.
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