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A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 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-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2019

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At a glance

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

    • 07 Nov 2019 Results assessing the efficacy and safety of elexacaftor-tezacaftor-ivacaftor were published in the New England Journal of Medicine
    • 31 Oct 2019 According to a Vertex Pharmaceuticals media release, an oral presentation highlighting key outcomes from both studies (NCT03525444 and NCT03525548) is scheduled on Friday, 1st Nov 2019.
    • 31 Oct 2019 According to a Vertex Pharmaceuticals media release, results from this study presented at the 33rd Annual North American Cystic Fibrosis Conference (NACFC, 31st Oct 2019).
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