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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2018

At a glance

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

    • 14 May 2018 Status changed from not yet recruiting to recruiting.
    • 01 Mar 2018 According to a Vertex Pharmaceuticals media release, data from the study will support the submission of an application for approval VX-659 in patients with two copies of the F508del mutation in the U.S, Europe and other regions.
    • 03 Feb 2018 New trial record
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