Major trial tests long-term safety of new cystic fibrosis treatment

NCT ID NCT05444257

Summary

This study is testing the long-term safety and effectiveness of a three-drug combination therapy (VX-121/TEZ/D-IVA) for people with cystic fibrosis. It follows 822 participants who previously completed earlier studies of this treatment. The main goals are to monitor side effects over time and see how well the treatment continues to work on lung function and other CF symptoms.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Academisch Medisch Centrum (Academic Medical Centre)

    Amsterdam, Netherlands

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Albany Medical College, Pulmonary and Critical Care Medicine

    Albany, New York, 12208, United States

  • Alfred Hospital

    Melbourne, Australia

  • All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough

    Penarth, United Kingdom

  • Atrium Health Levine Children's Hospital

    Charlotte, North Carolina, 28207, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

    Verona, Italy

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Florence, Italy

  • Azienda Ospedaliero Universitaria Ospedale Riuniti

    Ancona, Italy

  • Banner University of Arizona Medical Center

    Tucson, Arizona, 85724, United States

  • Billings Clinic

    Billings, Montana, 59101, United States

  • Birmingham Heartlands Hospital

    Birmingham, United Kingdom

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • British Columbia Children's Hospital

    Vancouver, Canada

  • CF Therapeutics Development Center of Western New York

    Buffalo, New York, 14203, United States

  • CHP - Hospital de Santo Antonio

    Porto, Portugal

  • CHU Lyon - Hopital Femme Mere-Enfant

    Bron, France

  • CHU de Rouen - Hopital Charles Nicolle

    Rouen, France

  • Canterbury District Health Board

    Christchurch, New Zealand

  • Cardinal Glennon Children's Hospital - St. Louis University

    St Louis, Missouri, 63104, United States

  • Central Florida Pulmonary Group,PA

    Orlando, Florida, 32803, United States

  • Centre Hospitalier Intercommunal Creteil

    Créteil, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

    Nice, France

  • Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu

    Montreal, Canada

  • Centre de Perharidy

    Roscoff, France

  • Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

    Potenza, Italy

  • Charite Paediatric Pulmonology Department

    Berlin, Germany

  • Children's Health Ireland at Crumlin

    Dublin, Ireland

  • Children's Health Ireland at Temple Street

    Dublin, Ireland

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Childrens Hospital University of Missouri Health Sciences Center

    Columbia, Missouri, 65212, United States

  • Clinical Research Facility

    Newcastle upon Tyne, United Kingdom

  • Clinical Research Facility, Queen Elizabeth University Hospital

    Glasgow, United Kingdom

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, Belgium

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, Belgium

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cook Children's Health Care System

    Fort Worth, Texas, 76104, United States

  • Cork University Hospital

    Cork, Ireland

  • Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

    Sabadell, Spain

  • Dartmouth Hitchcock

    Manchester, New Hampshire, 03104, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Fakultni nemocnice v Motole

    Prague, Czechia

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Italy

  • Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

    Milan, Italy

  • Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

    Erlangen, Germany

  • General Hospital of Thessaloniki "Papanikolaou"

    Thessaloniki, Greece

  • General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki

    Thessaloniki, Greece

  • Greenlane Clinical Centre

    One Tree Hill, New Zealand

  • Groupe Hospitaler Pellegrin, CHU De Bordeaux

    Bordeaux, France

  • Hadassah Medical Organization

    Jerusalem, Israel

  • HagaZiekenhuis van den Haag

    The Hague, Netherlands

  • Hannover Medical School

    Hanover, Germany

  • Harper University Hospital

    Detroit, Michigan, 48201, United States

  • Haukeland Universitetssjukehus (CF)

    Bergen, Norway

  • Hopital Arnaud de Villeneuve

    Montpellier, France

  • Hopital Bretonneau

    Tours, France

  • Hopital Cochin

    Paris, France

  • Hopital Foch (Suresnes), Hopital Foch, Adultes

    Suresnes, France

  • Hopital Robert Debre

    Paris, France

  • Hospital Saint Joan de Deu

    Barcelona, Spain

  • Hospital Sao Joao

    Porto, Portugal

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, Spain

  • Hospital Virgen de la Arrixaca

    Murcia, Spain

  • Hospital de Santa Maria

    Lisbon, Portugal

  • Hôpital de Hautepierre, AX5

    Strasbourg, France

  • IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

    Genova, Italy

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Institut Cœur Poumon, CHU de Lille

    Lille, France

  • Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval

    Québec, Canada

  • Institute for Respiratory Health

    Nedlands, Australia

  • Joe DiMaggio Cystic Fibrosis & Pulmonary Center

    Hollywood, Florida, 33021, United States

  • Johann Wolfgang Goethe University

    Frankfurt, Germany

  • Johannes Gutenberg-Universitaet

    Mainz, Germany

  • Johns Hopkins All Children's Hospital Outpatient Care Center

    St. Petersburg, Florida, 33701, United States

  • Juliane Marie Center, Rigshospitalet

    Copenhagen, Denmark

  • Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

    Giessen, Germany

  • Kaiser Permanente

    Oakland, California, 94611, United States

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, Sweden

  • Kinderklinik III, Abt. fur Pneumologie

    Essen, Germany

  • Kinderspital Zuerich

    Zurich, Switzerland

  • King's College Hospital

    London, United Kingdom

  • Klinika Detskych Infekcnich Nemoci

    Brno, Czechia

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

    Łomianki, Poland

  • Klinikum Westbrandenburg (CF)

    Potsdam, Germany

  • Leeds General Infirmary

    Leeds, United Kingdom

  • Liverpool Heart and Chest Hospital

    Liverpool, United Kingdom

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040, United States

  • Lund University Skanes Universitetssjukhus

    Lund, Sweden

  • Maine Medical Partners

    Portland, Maine, 04102, United States

  • Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

    Orbassano, Italy

  • Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center

    Boston, Massachusetts, 02114, United States

  • Mater Adult Hospital

    South Brisbane, Australia

  • McGill University Health Centre, Glen Site, Montreal Children's Hospital

    Montreal, Canada

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Medizinische Universität Innsbruck

    Innsbruck, Austria

  • Medizinische Universität Wien

    Vienna, Austria

  • Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • Miller Children's Hospital / Long Beach Memorial

    Long Beach, California, 90806, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

    Jena, Germany

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • National Koranyi Institute for TBC and Pulmonology

    Budapest, Hungary

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Nemours Children's Specialty Care

    Pensacola, Florida, 32514, United States

  • New York Medical College

    Valhalla, New York, 10595, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Oslo University Hospital, Department of Paediatric Medicine

    Oslo, Norway

  • Pediatric Hospital Polanki named of Maciej Płażyński

    Gdansk, Poland

  • Pneumologisches Studienzentrum Muenchen-West

    München, Germany

  • Prisma Health Richland Campus

    Columbia, South Carolina, 29203, United States

  • ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

    Toledo, Ohio, 43606, United States

  • Providence Pediatric Pulmonary & Cystic Fibrosis Clinic

    Spokane, Washington, 99204, United States

  • Pulmonology Institute Torokbalint

    Törökbálint, Hungary

  • Queensland Children's Hospital

    South Brisbane, Australia

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Royal Brompton Hospital

    London, United Kingdom

  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter, United Kingdom

  • Royal Manchester Children's Hospital

    Manchester, United Kingdom

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, United Kingdom

  • Royal Prince Alfred Hospital

    Camperdown, Australia

  • Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

    Essen, Germany

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Sweden

  • Sanford Children's Speciality Clinic

    Sioux Falls, South Dakota, 57105, United States

  • Santiago Reyes, M.D.

    Oklahoma City, Oklahoma, 73112, United States

  • Schneider Children's Medical Center of Israel

    Petach Tikvah, Israel

  • Sheba Medical Center - The Edmond and Lili Safra Children's Hospital

    Tel Litwinsky, Israel

  • Southampton General Hospital

    Southampton, United Kingdom

  • Spectrum Health Medical Group Adult Cystic Fibrosis Care Center

    Grand Rapids, Michigan, 49546, United States

  • St. Bartholomew's Hospital

    London, United Kingdom

  • St. James University Hospital

    Leeds, United Kingdom

  • St. Joseph's Health Care London

    London, Canada

  • St. Luke's Cystic Fibrosis Center of Idaho

    Boise, Idaho, 83702, United States

  • St. Paul's Hospital

    Vancouver, Canada

  • St. Vincent's University Hospital

    Dublin, Ireland

  • Starship Children's Hospital

    Grafton, New Zealand

  • Stollery Children's Hospital

    Edmonton, Canada

  • Telethon Kids Institute

    Nedlands, Australia

  • Texas Children's Hospital - Baylor College of Medicine

    Houston, Texas, 77030, United States

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • The Emory Clinic at Chantilly

    Atlanta, Georgia, 30324, United States

  • The Prince Charles Hospital

    Chermside, Australia

  • The Royal Children's Hospital

    Parkville, Australia

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Tulane Medical Center

    New Orleans, Louisiana, 70112, United States

  • UMC St. Radboud

    Nijmegen, Netherlands

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde

    Salzburg, Austria

  • Universitair Ziekenhuis Brussel - Campus Jette

    Brussels, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, Belgium

  • University Hospital Limerick (Pediatrics)

    Limerick, Ireland

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792, United States

  • University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

    Bristol, United Kingdom

  • University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

    Utrecht, Netherlands

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Calgary Medical Clinic of the Foothills Medical Centre

    Calgary, Canada

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California San Francisco, Lung Transplant Program

    San Francisco, California, 94143, United States

  • University of Florida, Shands Hospital

    Gainesville, Florida, 32610, United States

  • University of Graz

    Graz, Austria

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    Lexington, Kentucky, 40508, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)

    Ulm, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Germany

  • Vanderbilt University Medical Center, Nephrology Clinical Trials Center

    Nashville, Tennessee, 37232, United States

  • Vermont Lung Center

    Colchester, Vermont, 05446, United States

  • Waikato Hospital

    Hamilton, New Zealand

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27104, United States

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

    St Louis, Missouri, 63110, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Western General Hospital

    Edinburgh, United Kingdom

  • Westmead Hospital

    Westmead, Australia

  • Wythenshawe Hospital

    Manchester, United Kingdom

Conditions

Explore the condition pages connected to this study.