A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2017

At a glance

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

    • 24 Aug 2017 According to a Vertex media release, the U.S. FDA and the EMA have accepted to review the marketing applications for the use of tezacaftor/ivacaftor combination treatment in people with cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation or one F508del mutation and one residual function mutation that is responsive to tezacaftor/ivacaftor. In the US, the FDA has granted Priority Review of the New Drug Application (NDA) and set an action date of February 28, 2018.
    • 10 Jun 2017 Biomarkers information updated
    • 12 Apr 2017 Status changed from active, no longer recruiting to completed.
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