A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi

Trial Profile

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi

Completed
Phase of Trial: Phase II

Latest Information Update: 14 Nov 2017

At a glance

  • Drugs P 1037 (Primary) ; Ivacaftor; Lumacaftor
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 25 Oct 2017 Primary endpoint (Absolute change in percent predicted forced expiratory volume in 1 second (FEV1)) has not been met, according to a Vertex Pharmaceuticals media release.
    • 03 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 09 Aug 2017 Planned primary completion date changed from 25 Jul 2017 to 22 Aug 2017.
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