A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Last updated: June 14, 2023
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

3

Condition

Scar Tissue

Cystic Fibrosis

Lung Disease

Treatment

IVA

ELX/TEZ/IVA

Clinical Study ID

NCT04043806
VX18-445-113
2018-004652-38
  • Ages > 12
  • All Genders

Study Summary

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Currently participating in study VX17-659-105 (NCT03447262)

Exclusion

Exclusion Criteria:

  • History of drug intolerance in study VX17-659-105 that would pose an additional riskto the participant in the opinion of the investigator
  • Current participation in an investigational drug trial (other than study VX17-659-105) Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 458
Treatment Group(s): 2
Primary Treatment: IVA
Phase: 3
Study Start date:
August 09, 2019
Estimated Completion Date:
December 14, 2022

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Chermside,
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne, VIC,
    Australia

    Site Not Available

  • Institute for Respiratory Health

    Nedlands,
    Australia

    Site Not Available

  • Perth Children's Hospital

    Nedlands,
    Australia

    Site Not Available

  • John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital

    New Lambton,
    Australia

    Site Not Available

  • Queensland Children's Hospital

    South Brisbane,
    Australia

    Site Not Available

  • Stollery Children's Hospital

    Edmonton,
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Center

    Halifax,
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto,
    Canada

    Site Not Available

  • Juliane Marie Center, Rigshospitalet

    Copenhagen,
    Denmark

    Site Not Available

  • Charite Paediatric Pulmonology Department

    Berlin,
    Germany

    Site Not Available

  • Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

    Essen,
    Germany

    Site Not Available

  • Johann Wolfgang Goethe University

    Frankfurt,
    Germany

    Site Not Available

  • Hannover Medical School

    Hannover,
    Germany

    Site Not Available

  • Universitaetsklinikum Jena, Mukoviszidose-Zentrum

    Jena,
    Germany

    Site Not Available

  • Universitaetsklinkum Koeln, CF-Studienzentrum

    Koeln,
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin

    Lübeck,
    Germany

    Site Not Available

  • Pneumologisches Studienzentrum Muenchen-West

    Muenchen,
    Germany

    Site Not Available

  • Klinikum Innenstadt, University of Munich

    München,
    Germany

    Site Not Available

  • Cork University Hospital

    Cork,
    Ireland

    Site Not Available

  • Beaumont Hospital

    Dublin,
    Ireland

    Site Not Available

  • Children's Health Ireland at Crumlin

    Dublin,
    Ireland

    Site Not Available

  • Children's Health Ireland at Temple Street

    Dublin,
    Ireland

    Site Not Available

  • St. Vincent's University Hospital

    Dublin,
    Ireland

    Site Not Available

  • University Hospital Galway

    Galway,
    Ireland

    Site Not Available

  • University Hospital Limerick (Adults)

    Limerick,
    Ireland

    Site Not Available

  • Lady Davis Carmel Medical Center

    Haifa,
    Israel

    Site Not Available

  • Pediatric Pulmonary Unit Rambam Medical Center

    Haifa,
    Israel

    Site Not Available

  • Hadassah Medical Organization

    Jerusalem,
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah Tikva,
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Hashomer,
    Israel

    Site Not Available

  • Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY

    Łomianki,
    Poland

    Site Not Available

  • Hospital Universitari Vall d Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Infantil La Paz

    Madrid,
    Spain

    Site Not Available

  • Parc Tauli Sabadell Hospital Universitari

    Sabadell,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe

    Valencia,
    Spain

    Site Not Available

  • Lindenhofspital - Quartier Bleu

    Bern,
    Switzerland

    Site Not Available

  • Kinderspital Zuerich

    Zürich,
    Switzerland

    Site Not Available

  • Papworth Hospital NHS Foundation Trust, Papworth Everard

    Cambridge,
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde, Gartnavel General Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • St. James University Hospital

    Leeds,
    United Kingdom

    Site Not Available

  • Liverpool Heart and Chest Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester,
    United Kingdom

    Site Not Available

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary

    Newcastle Upon Tyne,
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust, Queens Medical Center

    Nottingham,
    United Kingdom

    Site Not Available

  • All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough

    Penarth,
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Nicklaus Children's Hospital

    Miami, Florida 33155
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Arnold Palmer Hospital Pulmonary and Sleep Medicine

    Orlando, Florida 32806
    United States

    Site Not Available

  • Johns Hopkins All Children's Hospital Outpatient Care Center

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • St. Luke's CF Center of Idaho

    Boise, Idaho 83702
    United States

    Site Not Available

  • Cystic Fibrosis Institute

    Glenview, Illinois 60025
    United States

    Site Not Available

  • Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants

    Niles, Illinois 60714
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • The University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Kosair Charities Pediatric Clinical Research Unit

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Michigan Medicine

    Ann Arbor, Michigan 48109-5212
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • The Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Washington University School of Medicine / St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Albany Medical College, Pulmonary and Critical Care Medicine

    Albany, New York 12208
    United States

    Site Not Available

  • Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo

    Buffalo, New York 14222
    United States

    Site Not Available

  • Northwell Health- Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Clinical Research of Charlotte

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Santiago Reyes, M.D.

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Sanford Children's Speciality Clinic

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Children's Foundation Research Center / Le Bonheur Children's Hospital

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah / Primary Children's Medical Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Providence Pediatric Pulmonary & Cystic Fibrosis Clinic

    Spokane, Washington 99204
    United States

    Site Not Available

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