A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy | MicrobiomeTrials← Back to trialsNCT05444257
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
RecruitingPHASE3INTERVENTIONAL
Trial Details
Start: 2022-11-08Est. Completion: 2026-10-30
Enrollment target: 822 participants Locations- 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
Other microbiome trials you might be interested in
Cystic Fibrosis
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic …
Innsbruck, AustriaEst. completion Apr 6, 2027
Cystic FibrosisPulmonary FibrosisTuberous SclerosisAsthmaPulmonary Sarcoidosis
This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved …
Bethesda, United States
Tulane Medical Center, New Orleans, Louisiana, United StatesMaine Medical Partners, Portland, Maine, United StatesMassachusetts General Hospital Cystic Fibrosis Center Clinical Research Center, Boston, Massachusetts, United StatesBoston Children's Hospital, Boston, Massachusetts, United StatesUMass Memorial Medical Center, Worcester, Massachusetts, United StatesMichigan Medicine, Ann Arbor, Michigan, United StatesHarper University Hospital, Detroit, Michigan, United StatesSpectrum Health Medical Group Adult Cystic Fibrosis Care Center, Grand Rapids, Michigan, United StatesUniversity of Minnesota, Minneapolis, Minnesota, United StatesChildrens Hospital University of Missouri Health Sciences Center, Columbia, Missouri, United StatesThe Children's Mercy Hospital, Kansas City, Missouri, United StatesCardinal Glennon Children's Hospital - St. Louis University, St Louis, Missouri, United StatesWashington University School of Medicine / St. Louis Children's Hospital, St Louis, Missouri, United StatesBillings Clinic, Billings, Montana, United StatesNebraska Medical Center, Omaha, Nebraska, United StatesDartmouth Hitchcock, Manchester, New Hampshire, United StatesMorristown Medical Center, Morristown, New Jersey, United StatesAlbany Medical College, Pulmonary and Critical Care Medicine, Albany, New York, United StatesCF Therapeutics Development Center of Western New York, Buffalo, New York, United StatesLong Island Jewish Medical Center, New Hyde Park, New York, United StatesColumbia University Medical Center, New York, New York, United StatesSUNY Upstate Medical University, Syracuse, New York, United StatesNew York Medical College, Valhalla, New York, United StatesAtrium Health Levine Children's Hospital, Charlotte, North Carolina, United StatesWake Forest Baptist Health, Winston-Salem, North Carolina, United StatesAkron Children's Hospital, Akron, Ohio, United StatesNationwide Children's Hospital, Columbus, Ohio, United StatesDayton Children's Hospital, Dayton, Ohio, United StatesProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center, Toledo, Ohio, United StatesUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United StatesSantiago Reyes, M.D., Oklahoma City, Oklahoma, United StatesOregon Health & Science University, Portland, Oregon, United StatesChildren's Hospital of Philadelphia, Philadelphia, Pennsylvania, United StatesUPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United StatesPrisma Health Richland Campus, Columbia, South Carolina, United StatesSanford Children's Speciality Clinic, Sioux Falls, South Dakota, United StatesUniversity of Tennessee Medical Center, Knoxville, Tennessee, United StatesVanderbilt University Medical Center, Nephrology Clinical Trials Center, Nashville, Tennessee, United StatesThe University of Texas Southwestern Medical Center, Dallas, Texas, United StatesCook Children's Health Care System, Fort Worth, Texas, United StatesTexas Children's Hospital - Baylor College of Medicine, Houston, Texas, United StatesUniversity of Utah, Salt Lake City, Utah, United StatesVermont Lung Center, Colchester, Vermont, United StatesUniversity of Virginia Health System, Charlottesville, Virginia, United StatesUniversity of Washington Medical Center, Seattle, Washington, United StatesProvidence Pediatric Pulmonary & Cystic Fibrosis Clinic, Spokane, Washington, United StatesWest Virginia University, Morgantown, West Virginia, United StatesUniversity Hospital and UW Health Clinics, Madison, Wisconsin, United StatesRoyal Prince Alfred Hospital, Camperdown, AustraliaThe Prince Charles Hospital, Chermside, AustraliaAlfred Hospital, Melbourne, AustraliaInstitute for Respiratory Health, Nedlands, AustraliaTelethon Kids Institute, Nedlands, AustraliaThe Royal Children's Hospital, Parkville, AustraliaMater Adult Hospital, South Brisbane, AustraliaQueensland Children's Hospital, South Brisbane, AustraliaWestmead Hospital, Westmead, AustraliaUniversity of Graz, Graz, AustriaMedizinische Universität Innsbruck, Innsbruck, AustriaUniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde, Salzburg, AustriaMedizinische Universität Wien, Vienna, AustriaCliniques Universitaires de Bruxelles Hopital Erasme, Brussels, BelgiumUniversitair Ziekenhuis Brussel - Campus Jette, Brussels, BelgiumUniversitair Ziekenhuis Gent, Ghent, BelgiumUniversitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, BelgiumCliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert, BelgiumUniversity of Calgary Medical Clinic of the Foothills Medical Centre, Calgary, CanadaStollery Children's Hospital, Edmonton, CanadaSt. Joseph's Health Care London, London, CanadaCentre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu, Montreal, CanadaMcGill University Health Centre, Glen Site, Montreal Children's Hospital, Montreal, CanadaInstitut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval, Québec, CanadaBritish Columbia Children's Hospital, Vancouver, CanadaSt. Paul's Hospital, Vancouver, CanadaKlinika Detskych Infekcnich Nemoci, Brno, CzechiaFakultni nemocnice v Motole, Prague, CzechiaAarhus University Hospital, Aarhus, DenmarkJuliane Marie Center, Rigshospitalet, Copenhagen, DenmarkGroupe Hospitaler Pellegrin, CHU De Bordeaux, Bordeaux, FranceCHU Lyon - Hopital Femme Mere-Enfant, Bron, FranceCentre Hospitalier Intercommunal Creteil, Créteil, FranceInstitut Cœur Poumon, CHU de Lille, Lille, FranceHopital Arnaud de Villeneuve, Montpellier, FranceCentre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur, Nice, FranceHopital Cochin, Paris, FranceHopital Robert Debre, Paris, FranceCentre Hospitalier Lyon Sud, Pierre-Bénite, FranceCentre de Perharidy, Roscoff, FranceCHU de Rouen - Hopital Charles Nicolle, Rouen, FranceHôpital de Hautepierre, AX5, Strasbourg, FranceHopital Foch (Suresnes), Hopital Foch, Adultes, Suresnes, FranceHopital Bretonneau, Tours, FranceCharite Paediatric Pulmonology Department, Berlin, GermanyFriedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital, Erlangen, GermanyKinderklinik III, Abt. fur Pneumologie, Essen, GermanyRuhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen, GermanyJohann Wolfgang Goethe University, Frankfurt, GermanyJustus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin, Giessen, GermanyHannover Medical School, Hanover, GermanyMedizinische Hochschule Hannover, Hanover, GermanyMukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin, Jena, GermanyJohannes Gutenberg-Universitaet, Mainz, GermanyPneumologisches Studienzentrum Muenchen-West, München, GermanyKlinikum Westbrandenburg (CF), Potsdam, GermanyUniversitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF), Ulm, GermanyUniversitätsklinikum Würzburg, Würzburg, GermanyGeneral Hospital of Thessaloniki "Papanikolaou", Thessaloniki, GreeceGeneral Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki, Thessaloniki, GreeceNational Koranyi Institute for TBC and Pulmonology, Budapest, HungaryPulmonology Institute Torokbalint, Törökbálint, HungaryCork University Hospital, Cork, IrelandChildren's Health Ireland at Crumlin, Dublin, IrelandChildren's Health Ireland at Temple Street, Dublin, IrelandSt. Vincent's University Hospital, Dublin, IrelandUniversity Hospital Limerick (Pediatrics), Limerick, IrelandHadassah Medical Organization, Jerusalem, IsraelClalit Health Services, Petach Tikvah, IsraelSafra Children's Hospital, Tel Litwinsky, IsraelAzienda Ospedaliero Universitaria Ospedale Riuniti, Ancona, ItalyAzienda Ospedaliero Universitaria Ospedale Pediatrico Meyer, Florence, ItalyIRCCS Istituto Giannina Gaslini-Ospedale Pediatrico, Genova, ItalyFondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, ItalyFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, ItalyMalattie Apparato Respiratorio 2 - Centro Fibrosi Cistica, Orbassano, ItalyCentro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo, Potenza, ItalyAzienda Ospedaliera di Verona - Ospedale Civile Maggiore, Verona, ItalyAcademisch Medisch Centrum (Academic Medical Centre), Amsterdam, NetherlandsUMC St. Radboud, Nijmegen, NetherlandsErasmus Medical Center, Rotterdam, NetherlandsHagaZiekenhuis van den Haag, The Hague, NetherlandsUniversity Medical Center, Utrecht, Department of Pulmonology and Tuberculosis, Utrecht, NetherlandsCanterbury District Health Board, Christchurch, New ZealandStarship Children's Hospital, Grafton, New ZealandWaikato Hospital, Hamilton, New ZealandGreenlane Clinical Centre, One Tree Hill, New ZealandHaukeland Universitetssjukehus (CF), Bergen, NorwayOslo University Hospital, Department of Paediatric Medicine, Oslo, NorwayPediatric Hospital Polanki named of Maciej Płażyński, Gdansk, PolandKlinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY, Łomianki, PolandHospital de Santa Maria, Lisbon, PortugalCHP - Hospital de Santo Antonio, Porto, PortugalHospital Sao Joao, Porto, PortugalHospital Saint Joan de Deu, Barcelona, SpainHospital Universitari Vall d'Hebron, Barcelona, SpainHospital Universitario 12 de Octubre, Madrid, SpainHospital Universitario Ramon y Cajal, Madrid, SpainHospital Virgen de la Arrixaca, Murcia, SpainCorporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari, Sabadell, SpainHospital Universitario Virgen del Rocio, Seville, SpainHospital Universitario y Politecnico La Fe, Valencia, SpainSahlgrenska Universitetssjukhuset, Gothenburg, SwedenLund University Skanes Universitetssjukhus, Lund, SwedenKarolinska Universitetssjukhuset, Huddinge, Stockholm, SwedenKinderspital Zuerich, Zurich, SwitzerlandBirmingham Heartlands Hospital, Birmingham, United KingdomUniversity Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital, Bristol, United KingdomRoyal Papworth Hospital NHS Foundation Trust, Cambridge, United KingdomWestern General Hospital, Edinburgh, United KingdomRoyal Devon University Healthcare NHS Foundation Trust, Exeter, United KingdomClinical Research Facility, Queen Elizabeth University Hospital, Glasgow, United KingdomLeeds General Infirmary, Leeds, United KingdomSt. James University Hospital, Leeds, United KingdomLiverpool Heart and Chest Hospital, Liverpool, United KingdomKing's College Hospital, London, United KingdomRoyal Brompton Hospital, London, United KingdomSt. Bartholomew's Hospital, London, United KingdomRoyal Manchester Children's Hospital, Manchester, United KingdomWythenshawe Hospital, Manchester, United KingdomClinical Research Facility, Newcastle upon Tyne, United KingdomAll Wales Adult Cystic Fibrosis Centre, University Hospital Llandough, Penarth, United KingdomSouthampton General Hospital, Southampton, United KingdomThe purpose of Parts D and E of this Phase 1 study are to evaluate the safety, tolerability, and pharmacokinetics of mul…
Brisbane, AustraliaCompleted Mar 23, 2026