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Clinical trialNCT00909532CompletedPhase 3Interventional

Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation

SponsorVertex Pharmaceuticals IncorporatedEnrollment167Cystic Fibrosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

65 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • the Children'S Hospital Westmead

    Westmead, New South Wales, Australia

  • the Prince Charles Hospital

    Chermside, Queensland, Australia

  • Royal Children'S Hospital Brisbane

    Herston, Queensland, Australia

  • Mater Adult Hospital

    South Brisbane, Queensland, Australia

  • Royal Children'S Hospital Melbourne

    Parkville, Victoria, Australia

  • Lung Institute of Western Australia

    Nedlands, Western Australia, Australia

  • Princess Margaret Hospital for Children

    Subiaco, Western Australia, Australia

Canada
  • Queen Elizabeth Ii Health Sciences Centre

    Halifax, Nova Scotia, Canada

  • Cf Center, Hospital for Sick Children

    Toronto, Ontario, Canada

  • St. Michael'S Hospital

    Toronto, Ontario, Canada

  • Montreal Children'S Hospital - Muhc

    Montreal, Quebec, Canada

Czechia
  • Fn Motol

    Prague, Czechia

France
  • Hopital Cochin

    Paris, France

  • Hopital Necker

    Paris, France

  • Centre de Perharidy

    Roscoff, France

Germany
  • Kinder- Und Jugendklinik Universitätsklinikum Erlangen

    Erlangen, Germany

  • Mukoviszidose-Zentrum Am Klinikum Der Friedrich-Schiller-Universität Jena, Klinik Für Kinder- Und Jugendmedizin

    Jena, Germany

  • Klinikum Der Lmu München, Dr. Von Haunersches Kinderspital (cha)

    Munich, Germany

  • Universitäts-Kinderklinik Würzburg

    Würzburg, Germany

Ireland
  • Cork University Hospital

    Cork, Ireland

  • Beaumont Hospital

    Dublin, Ireland

  • Our Lady'S Children'S Hospital

    Dublin, Ireland

  • St. Vincent'S University Hospital

    Dublin, Ireland

  • the National Children'S Hospital

    Dublin, Ireland

United Kingdom
  • Belfast City Hospital

    Belfast, Northern Ireland, United Kingdom

  • Imperial College London

    London, United Kingdom

United States
  • University of Alabama

    Birmingham, Alabama, United States

  • Kaiser Permanente Medical Care Program

    Oakland, California, United States

  • Cystic Fibrosis Research Office, Stanford University

    Palo Alto, California, United States

  • Rady Children'S Hospital

    San Diego, California, United States

  • National Jewish Medical and Research Center

    Denver, Colorado, United States

  • Emory Cystic Fibrosis Center

    Atlanta, Georgia, United States

  • St. Luke'S Cf Clinic

    Boise, Idaho, United States

  • Children'S Memorial Hospital

    Chicago, Illinois, United States

  • Indiana University

    Indianapolis, Indiana, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • Johns Hopkins University

    Baltimore, Maryland, United States

  • Children'S Hospital Boston

    Boston, Massachusetts, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • University of Michigan

    Ann Arbor, Michigan, United States

25 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2009
Primary completion
31 Jul 2010
Completion
30 Nov 2012
Last update posted
18 Jan 2013
Registered enrollment
167
Registry id
NCT00909532

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.