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A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation

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Trial Profile

A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Feb 2024

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At a glance

  • Drugs Ivacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms ARRIVAL
  • Sponsors Vertex Pharmaceuticals

    • Most Recent Events

    • 23 Feb 2024 According to Vertex Pharmaceuticals media release, company announced that the European Medicines Agencys (EMAs) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KALYDECO (ivacaftor) for the treatment of infants with cystic fibrosis (CF) ages 1 month to less than 4 months.
    • 14 Aug 2023 The protocol has been amended as above-1) number of treatment arms has been changed from 3 to 2. 2) In design parallel assignment has been added.3)actual patient number has been changed from 56 to 57.
    • 03 May 2023 According to Vertex Pharmaceuticals media release, the USFDA approved KALYDECO (ivacaftor) for use in children with cystic fibrosis (CF) ages 1 month to less than four months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to KALYDECO based on clinical and/or in vitro assay data; The approval was supported by a cohort in this study in subjects who are less than 24 months of age and have an ivacaftor-responsive CFTR mutatio
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