A Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation

Trial Profile

A Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2017

At a glance

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

    • 04 Mar 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 10 Dec 2015 Planned primary completion date changed from 1 Nov 2015 to 1 Dec 2015 as reported by ClinicalTrials.gov.
    • 02 Apr 2015 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
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