NCT05076149CompletedPhase 3
A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation
Source: ClinicalTrials.gov · Last updated 13 Jun 2024
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 597 (actual)
- First submitted
- 29 Sept 2021
- Start date
- 27 Oct 2021
- Primary completion date
- 18 May 2023
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT05076149
- EudraCT number
- 2021-000694-85
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 597
- From 27 Oct 2021 to the primary completion date, 18 May 2023
- 170 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of solid organ or hematological transplantation
- Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
- Lung infection with organisms associated with a more rapid decline in pulmonary status
Other
- Pregnant or breast-feeding females
- Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Participant has one of the following genotypes:
- Homozygous for F508del;
- Heterozygous for F508del and a gating (F/G) mutation;
- Heterozygous for F508del and a residual function (F/RF) mutation;
- At least 1 other TCR CFTR gene mutation identified as responsive to ELX/TEZ/IVA and no F508del mutation
- Forced expiratory volume in 1 second (FEV1) value \>=40% and \<=90% of predicted mean for age, sex, and height for participants currently receiving CFTR protein modulator therapy; FEV1 \>=40% and \<=80% for participants not currently receiving CFTR protein modulator therapy
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (170)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Medizinische Universität Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
| Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde Coordinator of this site? Confirm its status | Salzburg | Austria | Unknown status |
| Medizinische Universität Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Abteilung fuer Pulmologie Klinikum Wels-Grieskirchen Coordinator of this site? Confirm its status | Wels | Austria | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| The Prince Charles Hospital Coordinator of this site? Confirm its status | Chermside | Australia | Unknown status |
| Alfred Hospital Coordinator of this site? Confirm its status | Melbourne, VIC | Australia | Unknown status |
| Institute for Respiratory Health Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Telethon Kids Institute Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| The Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville, VIC | Australia | Unknown status |
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Mater Adult Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Cliniques Universitaires de Bruxelles Hopital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitair Ziekenhuis Brussel - Campus Jette Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Unknown status |
| University of Calgary Medical Clinic of the Foothills Medical Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Stollery Children'S Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| St. Joseph's Health Care London Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Health Centre, Glen Site, Montreal Children's Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| British Columbia Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Lindenhofspital - Quartier Bleu Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Réseau Hospitalier Neuchâtelois Coordinator of this site? Confirm its status | Neuchâtel | Switzerland | Unknown status |
| Kinderspital Zuerich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Charité - Paediatric Pulmonology Department Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Pneumologisches Studienzentrum Muenchen-West Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Juliane Marie Center, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Groupe Hospitaler Pellegrin, CHU De Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU Lyon - Hopital Femme Mere-Enfant Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Institut Cœur Poumon CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Arnaud de Villeneuve Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Centre Hospitalier Universitaire De Nantes - G. R. Laennec Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Robert Debre Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Centre de Perharidy Coordinator of this site? Confirm its status | Roscoff | France | Unknown status |
| CHU de Rouen - Hopital Charles Nicolle Coordinator of this site? Confirm its status | Rouen Cedex, Seine Maritime | France | Unknown status |
| Hôpital de Hautepierre, AX5 Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hopital Foch (Suresnes), Hopital Foch, Adultes Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
| Hopital Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Centre hospitalier universitaire de Nancy, Hôpital de Braboi Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Royal Papworth Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Clinical Research Facility, Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| St James University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Royal Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Manchester Children's Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Wythenshawe Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough Coordinator of this site? Confirm its status | Penarth | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| General Hospital of Thessaloniki "Papanikolaou" Coordinator of this site? Confirm its status | Pilea Chortiatis | Greece | Unknown status |
| General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| National Koranyi Institute for TBC and Pulmonology Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Pulmonology Institute Torokbalint Coordinator of this site? Confirm its status | Törökbálint | Hungary | Unknown status |
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Unknown status |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Children's Health Ireland at Crumlin Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Children's University Hospital, Dublin Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Children's Health Ireland at Tallaght Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| University Hospital Limerick (Pediatrics) Coordinator of this site? Confirm its status | Limerick | Ireland | Unknown status |
| University Hospital Limerick (Adults) Coordinator of this site? Confirm its status | Limerick | Ireland | Unknown status |
| Hadassah Medical Organization Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center of Israel Coordinator of this site? Confirm its status | Petach Tikvah | Israel | Unknown status |
| Sheba Medical Center - The Edmond and Lili Safra Children's Hospital Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Unknown status |
| Azienda Ospedaliero Universitaria Ospedale Riuniti Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo Coordinator of this site? Confirm its status | Potenza | Italy | Unknown status |
| Azienda Ospedaliera di Verona - Ospedale Civile Maggiore Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Academisch Medisch Centrum (Academic Medical Centre) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| UMC St Radboud Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| HagaZiekenhuis van Den Haag Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Haukeland Universitetssjukehus (CF) Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Oslo University Hospital, Department of Paediatric Medicine Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Starship Children's Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Greenlane Clinical Centre Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Canterbury Respiratory Research Group Coordinator of this site? Confirm its status | Christchurch Hospital | New Zealand | Unknown status |
| Waikato Hospital Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
| Pediatric Hospital Polanki named of Maciej Płażyński Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY Coordinator of this site? Confirm its status | Łomianki | Poland | Unknown status |
| Institute of Tuberculosis and Lung Diseases Coordinator of this site? Confirm its status | Rabka-Zdrój | Poland | Unknown status |
| Sahlgrenska Universitetssjukhuset Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Lund University Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Karolinska universitetssjukhuset - Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Akron Children's Hospital Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| The Emory Clinic at Chantilly Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Billings Clinic Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| St. Luke's Cystic Fibrosis Center of Idaho Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| CF Therapeutics Development Center of Western New York Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Vermont Lung Center Coordinator of this site? Confirm its status | Colchester | United States | Unknown status |
| Prisma Health Richland Campus Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Harper University Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Cook Children's Health Care System Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Spectrum Health Medical Group Adult Cystic Fibrosis Care Center Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Riley Hospital for Children at Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Children's Specialty Care Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| The Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Tennessee Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University Hospital and UW Health Clinics Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Northwell Health/Long Island Jewish Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Tulane Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital of The King's Daughters Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Santiago Reyes, M.D. Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Central Florida Pulmonary Group, PA Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Nemours Children's Specialty Care, Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UPMC Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Maine Medical Partners Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of California, Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of Utah - Primary Children's Medical Center Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Sanford Children's Speciality Clinic Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Pediatric Pulmonary & Cystic Fibrosis Clinic Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Johns Hopkins All Children's Hospital Outpatient Care Center Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Banner University of Arizona Medical Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Wake Forest Baptist Health Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.