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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)

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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: 12 Dec 2022

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At a glance

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

    • Most Recent Events

    • 18 May 2022 Results by deriving clinical efficacy inputs were derived from NCT03691779, NCT03525444; estimating survival in Brazilian F/MF pwCF aged 6 years receiving ELX/TEZ/IVA+best supportive care (BSC) versus BSC-alone, presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 18 Jun 2021 According to a Vertex Pharmaceuticals media release, Health Canada has granted Marketing Authorization for TRIKAFTA for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation.This approval was supported by positive results of three global Phase 3 studies (Study 445-102, Study 445-103 and Study 445-104).
    • 20 May 2021 Results of simulation model to determine survival data in F508del and a minimal function mutation population by using data from this study presented at the 26th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
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