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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: 02 May 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

  • 26 Apr 2024 According to Vertex Pharmaceuticals media release, company announced that the European Commission has granted approval for the label expansion of KALYDECO (ivacaftor) for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
  • 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.

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