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 a CFTR Gating Mutation

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 a CFTR Gating Mutation

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2017

At a glance

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

    • 07 Dec 2017 According to a company media release, based on the results of this trial, Vertex plans to submit applications for ivacaftor in children ages 1 to 2 years to the US FDA and the European Medicines Agency (EMA) in the first quarter of 2018. Full results from the study will be submitted for presentation at an upcoming medical conference.
    • 07 Dec 2017 Results (n = 19) presented in a Vertex Pharmaceuticals media release.
    • 15 Aug 2017 Planned End Date changed from 1 Sep 2018 to 1 Jun 2020.
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