NCT05033080CompletedPhase 3
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
Source: ClinicalTrials.gov · Last updated 3 Oct 2024
Brief summary (registry, in English)
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 435 (actual)
- First submitted
- 26 Aug 2021
- Start date
- 14 Sept 2021
- Primary completion date
- 12 May 2023
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT05033080
- EudraCT number
- 2021-000712-31
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 435
- From 14 Sept 2021 to the primary completion date, 12 May 2023
- 139 sites in 12 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
- Heterozygous for F508del and a minimal function mutation (F/MF genotype)
- Forced expiratory volume in 1 second (FEV1) value \>=40% and \<=90% of predicted mean for age, sex, and height for participants currently receiving ELX/TEZ/IVA therapy; FEV1 \>=40% and \<=80% for participants not currently receiving ELX/TEZ/IVA
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (139)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site 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 |
| 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 |
| Klinika Detskych Infekcnich Nemoci Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Charité - Paediatric Pulmonology Department Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| St. Josef Hospital Coordinator of this site? Confirm its status | Bochum | Germany | Unknown status |
| Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Johann Wolfgang Goethe University Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Johannes Gutenberg-Universitaet Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Pneumologisches Studienzentrum Muenchen-West Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Klinikum Innenstadt, University of Munich Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Klinikum Westbrandenburg (CF) Coordinator of this site? Confirm its status | Potsdam | Germany | Unknown status |
| Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF) Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Hospital Saint Joan de Deu Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Royal Papworth Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Royal Hospital for Sick Children Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Royal Devon and Exeter Hospital Coordinator of this site? Confirm its status | Exeter | 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 |
| Liverpool Heart and Chest Hospital Coordinator of this site? Confirm its status | Liverpool | 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 Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Wythenshawe Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Clinical Research Facility Coordinator of this site? Confirm its status | Newcastle upon Tyne | 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 |
| 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 Health Ireland at Temple Street 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 (Adults) Coordinator of this site? Confirm its status | Limerick | Ireland | Unknown status |
| University Hospital Limerick (Pediatrics) Coordinator of this site? Confirm its status | Limerick | Ireland | Unknown status |
| Hadassah University Hospital - Mount Scopus 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 |
| Greenlane Clinical Centre Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Starship Children's Hospital 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 |
| Hospital De Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Hospital Sao Joao Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| CHP - Hospital de Santo Antonio Coordinator of this site? Confirm its status | Porto | Portugal | 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 |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | 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 |
| Augusta University Coordinator of this site? Confirm its status | Augusta | 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 |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | 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 |
| CF Therapeutics Development Center of Western New York Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Atrium Health/Levine Children's Hospital Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | 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 |
| Cleveland Clinic CF Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Vermont Lung Center Coordinator of this site? Confirm its status | Colchester | United States | Unknown status |
| Childrens Hospital University of Missouri Health Sciences Center 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 |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | 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 |
| Inova Fairfax Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Cook Children's Health Care System Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| University of Florida Shands Hospital Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Helen DeVos Children's Hospital CF Center Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Joe DiMaggio Cystic Fibrosis & Pulmonary Center Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Texas Children's Hospital/ Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | 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 |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | 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 |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Miller Children's Hospital / Long Beach Memorial Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Kosair Charities Pediatric Clinical Research Unit Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| University of Wisconsin Hospital and Clinics Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Dartmouth-Hitchcock Manchester Coordinator of this site? Confirm its status | Manchester | United States | Unknown status |
| Children's Foundation Research Center / Le Bonheur Children's Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | 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 |
| 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 |
| Kaiser Permanente Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Central Florida Pulmonary Group, PA Coordinator of this site? Confirm its status | Orlando | 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 |
| 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 California San Francisco, Lung Transplant Program Coordinator of this site? Confirm its status | San Francisco | 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 |
| Cardinal Glennon Children's Hospital - St. Louis University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine/St. Louis Children's Hospital 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 |
| 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 |
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | 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.