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ACTIVE NOT RECRUITING
NCT05444257
PHASE3

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Sponsor: Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

Official title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

822

Start Date

2022-11-08

Completion Date

2026-10-30

Last Updated

2025-09-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

VX-121/TEZ/D-IVA

Fixed-dose combination tablets for oral administration.

Locations (195)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner University of Arizona Medical Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Miller Children's Hospital / Long Beach Memorial

Long Beach, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Kaiser Permanente

Oakland, California, United States

University of California Davis Medical Center

Sacramento, California, United States

University of California San Francisco, Lung Transplant Program

San Francisco, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

National Jewish Health

Denver, Colorado, United States

University of Florida, Shands Hospital

Gainesville, Florida, United States

Joe DiMaggio Cystic Fibrosis & Pulmonary Center

Hollywood, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Central Florida Pulmonary Group,PA

Orlando, Florida, United States

Nemours Children's Specialty Care

Pensacola, Florida, United States

Johns Hopkins All Children's Hospital Outpatient Care Center

St. Petersburg, Florida, United States

The Emory Clinic at Chantilly

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

St. Luke's Cystic Fibrosis Center of Idaho

Boise, Idaho, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Tulane Medical Center

New Orleans, Louisiana, United States

Maine Medical Partners

Portland, Maine, United States

Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Michigan Medicine

Ann Arbor, Michigan, United States

Harper University Hospital

Detroit, Michigan, United States

Spectrum Health Medical Group Adult Cystic Fibrosis Care Center

Grand Rapids, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Childrens Hospital University of Missouri Health Sciences Center

Columbia, Missouri, United States

The Children's Mercy Hospital

Kansas City, Missouri, United States

Cardinal Glennon Children's Hospital - St. Louis University

St Louis, Missouri, United States

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

St Louis, Missouri, United States

Billings Clinic

Billings, Montana, United States

Nebraska Medical Center

Omaha, Nebraska, United States

Dartmouth Hitchcock

Manchester, New Hampshire, United States

Morristown Medical Center

Morristown, New Jersey, United States

Albany Medical College, Pulmonary and Critical Care Medicine

Albany, New York, United States

CF Therapeutics Development Center of Western New York

Buffalo, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Columbia University Medical Center

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

New York Medical College

Valhalla, New York, United States

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Dayton Children's Hospital

Dayton, Ohio, United States

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

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Santiago Reyes, M.D.

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Prisma Health Richland Campus

Columbia, South Carolina, United States

Sanford Children's Speciality Clinic

Sioux Falls, South Dakota, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Vanderbilt University Medical Center, Nephrology Clinical Trials Center

Nashville, Tennessee, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Cook Children's Health Care System

Fort Worth, Texas, United States

Texas Children's Hospital - Baylor College of Medicine

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Vermont Lung Center

Colchester, Vermont, United States

University of Virginia Health System

Charlottesville, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Providence Pediatric Pulmonary & Cystic Fibrosis Clinic

Spokane, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

University Hospital and UW Health Clinics

Madison, Wisconsin, United States

Royal Prince Alfred Hospital

Camperdown, Australia

The Prince Charles Hospital

Chermside, Australia

Alfred Hospital

Melbourne, Australia

Institute for Respiratory Health

Nedlands, Australia

Telethon Kids Institute

Nedlands, Australia

The Royal Children's Hospital

Parkville, Australia

Mater Adult Hospital

South Brisbane, Australia

Queensland Children's Hospital

South Brisbane, Australia

Westmead Hospital

Westmead, Australia

University of Graz

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde

Salzburg, Austria

Medizinische Universität Wien

Vienna, Austria

Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, Belgium

Universitair Ziekenhuis Brussel - Campus Jette

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

University of Calgary Medical Clinic of the Foothills Medical Centre

Calgary, Canada

Stollery Children's Hospital

Edmonton, Canada

St. Joseph's Health Care London

London, Canada

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

Montreal, Canada

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

Montreal, Canada

Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval

Québec, Canada

British Columbia Children's Hospital

Vancouver, Canada

St. Paul's Hospital

Vancouver, Canada

Klinika Detskych Infekcnich Nemoci

Brno, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Aarhus University Hospital

Aarhus, Denmark

Juliane Marie Center, Rigshospitalet

Copenhagen, Denmark

Groupe Hospitaler Pellegrin, CHU De Bordeaux

Bordeaux, France

CHU Lyon - Hopital Femme Mere-Enfant

Bron, France

Centre Hospitalier Intercommunal Creteil

Créteil, France

Institut Cœur Poumon, CHU de Lille

Lille, France

Hopital Arnaud de Villeneuve

Montpellier, France

Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

Nice, France

Hopital Cochin

Paris, France

Hopital Robert Debre

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Centre de Perharidy

Roscoff, France

CHU de Rouen - Hopital Charles Nicolle

Rouen, France

Hôpital de Hautepierre, AX5

Strasbourg, France

Hopital Foch (Suresnes), Hopital Foch, Adultes

Suresnes, France

Hopital Bretonneau

Tours, France

Charite Paediatric Pulmonology Department

Berlin, Germany

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

Erlangen, Germany

Kinderklinik III, Abt. fur Pneumologie

Essen, Germany

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

Essen, Germany

Johann Wolfgang Goethe University

Frankfurt, Germany

Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

Giessen, Germany

Hannover Medical School

Hanover, Germany

Medizinische Hochschule Hannover

Hanover, Germany

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

Jena, Germany

Johannes Gutenberg-Universitaet

Mainz, Germany

Pneumologisches Studienzentrum Muenchen-West

München, Germany

Klinikum Westbrandenburg (CF)

Potsdam, Germany

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

Ulm, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

General Hospital of Thessaloniki "Papanikolaou"

Thessaloniki, Greece

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

Thessaloniki, Greece

National Koranyi Institute for TBC and Pulmonology

Budapest, Hungary

Pulmonology Institute Torokbalint

Törökbálint, Hungary

Cork University Hospital

Cork, Ireland

Children's Health Ireland at Crumlin

Dublin, Ireland

Children's Health Ireland at Temple Street

Dublin, Ireland

St. Vincent's University Hospital

Dublin, Ireland

University Hospital Limerick (Pediatrics)

Limerick, Ireland

Hadassah Medical Organization

Jerusalem, Israel

Schneider Children's Medical Center of Israel

Petach Tikvah, Israel

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

Tel Litwinsky, Israel

Azienda Ospedaliero Universitaria Ospedale Riuniti

Ancona, Italy

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

Florence, Italy

IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

Genova, Italy

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Milan, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

Orbassano, Italy

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

Potenza, Italy

Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

Verona, Italy

Academisch Medisch Centrum (Academic Medical Centre)

Amsterdam, Netherlands

UMC St. Radboud

Nijmegen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

HagaZiekenhuis van den Haag

The Hague, Netherlands

University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

Utrecht, Netherlands

Canterbury District Health Board

Christchurch, New Zealand

Starship Children's Hospital

Grafton, New Zealand

Waikato Hospital

Hamilton, New Zealand

Greenlane Clinical Centre

One Tree Hill, New Zealand

Haukeland Universitetssjukehus (CF)

Bergen, Norway

Oslo University Hospital, Department of Paediatric Medicine

Oslo, Norway

Pediatric Hospital Polanki named of Maciej Płażyński

Gdansk, Poland

Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY

Łomianki, Poland

Hospital de Santa Maria

Lisbon, Portugal

CHP - Hospital de Santo Antonio

Porto, Portugal

Hospital Sao Joao

Porto, Portugal

Hospital Saint Joan de Deu

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Virgen de la Arrixaca

Murcia, Spain

Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

Sabadell, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Lund University Skanes Universitetssjukhus

Lund, Sweden

Karolinska Universitetssjukhuset, Huddinge

Stockholm, Sweden

Kinderspital Zuerich

Zurich, Switzerland

Birmingham Heartlands Hospital

Birmingham, United Kingdom

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

Bristol, United Kingdom

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Royal Devon University Healthcare NHS Foundation Trust

Exeter, United Kingdom

Clinical Research Facility, Queen Elizabeth University Hospital

Glasgow, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

St. James University Hospital

Leeds, United Kingdom

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

King's College Hospital

London, United Kingdom

Royal Brompton Hospital

London, United Kingdom

St. Bartholomew's Hospital

London, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

Wythenshawe Hospital

Manchester, United Kingdom

Clinical Research Facility

Newcastle upon Tyne, United Kingdom

All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough

Penarth, United Kingdom

Southampton General Hospital

Southampton, United Kingdom