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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Apr 2018

At a glance

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

    • 21 Feb 2018 Status changed from not yet recruiting to recruiting.
    • 21 Feb 2018 According to a Vertex Pharmaceuticals media release, this study is designed to support the submission of a New Drug Application (NDA) in the U.S., Europe and other regions, using data from the 4-week primary efficacy endpoint together with safety data through 12 weeks of treatment.
    • 03 Feb 2018 New trial record
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