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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 Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

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 Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2018

At a glance

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

    • 27 Nov 2018 Results presented in a Vertex Pharmaceuticals media release.
    • 27 Nov 2018 Primary endpoint has been met. (Absolute change in ppFEV1), according to a Vertex Pharmaceuticals media release.
    • 06 Sep 2018 According to a Vertex Pharmaceuticals media release, additional safety and efficacy data, including secondary endpoints followed by the completion of the study is expected in the second half of 2019.
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