Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR gating mutation in at least 1 allele and will further explore the efficacy of long-term ivacaftor treatment in this population of patients with CF.

Key facts

Study ID

NCT01946412

Run by

Vertex Pharmaceuticals Incorporated

People needed

33

Starts

2013-12-01

Expected to finish

2015-12-01

Last updated by the study team

2017-02-01

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Denver, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Richmond, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Vancouver, British Columbia, Canada
• Study site — Edinburgh, United Kingdom
• Study site — Liverpool, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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