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NCT05444257Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
822 (actual)
First submitted
29 Jun 2022
Start date
8 Nov 2022
Primary completion date
30 Oct 2026
Lead sponsor
Vertex Pharmaceuticals Incorporated
NCT number
NCT05444257
EU CT number
2024-514173-22-00
EudraCT number
2021-000713-17

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 822
  • From 8 Nov 2022 to the primary completion date, 30 Oct 2026
  • 193 sites in 23 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 drug intolerance in a parent study

Other

  • Pregnant or breast-feeding females at the time of enrollment in Part A
    • Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
  • Part B: Completed study drug treatment in Part A; or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (193)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Hospital Graz
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GrazAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
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SalzburgAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
The Prince Charles Hospital
Coordinator of this site? Confirm its status
ChermsideAustraliaUnknown status
Alfred Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Institute for Respiratory Health
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Telethon Kids Institute
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
The Royal Children's Hospital
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ParkvilleAustraliaUnknown status
Queensland Children's Hospital
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South BrisbaneAustraliaUnknown status
Mater Adult Hospital
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South BrisbaneAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
Hopital Erasme
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AnderlechtBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Brussel
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JetteBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
University of Calgary Medical Clinic of the Foothills Medical Centre
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CalgaryCanadaUnknown status
Stollery Children'S Hospital
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EdmontonCanadaUnknown status
St. Joseph's Health Care London
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LondonCanadaUnknown status
McGill University Health Centre, Glen Site, Montreal Children's Hospital
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MontrealCanadaUnknown status
Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu
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MontrealCanadaUnknown status
Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval
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QuébecCanadaUnknown status
British Columbia Children's Hospital
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VancouverCanadaUnknown status
St. Paul's Hospital
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VancouverCanadaUnknown status
Kinderspital Zuerich
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ZurichSwitzerlandUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyActive, not recruiting
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
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EssenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyActive, not recruiting
Universitaetsklinikum Giessen und Marburg GmbH
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GiessenGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Pneumological Study Center Munich-West
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MunichGermanyActive, not recruiting
Klinikum Ernst von Bergmann gGmbH
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PotsdamGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Aarhus Universitetshospital
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Sant Joan De Deu Barcelona Hospital
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Esplugues De LlobregatSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Parc Tauli Hospital Universitari
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SabadellSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceActive, not recruiting
Hopital Cardiologique
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Lille CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Robert Debre University Hospital
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ParisFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Fondation ILDYS
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RoscoffFranceActive, not recruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Hospital Foch
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SuresnesFranceActive, not recruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceActive, not recruiting
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital
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BristolUnited KingdomUnknown status
Royal Papworth Hospital NHS Foundation Trust
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CambridgeUnited KingdomUnknown status
Western General Hospital
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EdinburghUnited KingdomUnknown status
Royal Devon University Healthcare NHS Foundation Trust
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ExeterUnited KingdomUnknown status
Clinical Research Facility, Queen Elizabeth University Hospital
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GlasgowUnited KingdomUnknown status
St James University Hospital
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LeedsUnited KingdomUnknown status
Leeds General Infirmary
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LeedsUnited KingdomUnknown status
Liverpool Heart and Chest Hospital
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LiverpoolUnited KingdomUnknown status
King's College Hospital
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LondonUnited KingdomUnknown status
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
Royal Brompton Hospital
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LondonUnited KingdomUnknown status
Royal Manchester Children's Hospital
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ManchesterUnited KingdomUnknown status
Wythenshawe Hospital
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ManchesterUnited KingdomUnknown status
Clinical Research Facility
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Newcastle upon TyneUnited KingdomUnknown status
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
Coordinator of this site? Confirm its status
PenarthUnited KingdomUnknown status
Southampton General Hospital
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomUnknown status
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
Ippokratio General Hospital of Thessaloniki
Coordinator of this site? Confirm its status
ThessalonikiGreeceActive, not recruiting
Orszagos Koranyi Pulmonologiai Intezet
Coordinator of this site? Confirm its status
Budapest XIIHungaryActive, not recruiting
Református Pulmonológiai Centrum
Coordinator of this site? Confirm its status
TörökbálintHungaryActive, not recruiting
Cork University Hospital
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CorkIrelandActive, not recruiting
Children's Health Ireland
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Dublin 1IrelandActive, not recruiting
Children's Health Ireland
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Dublin 12IrelandActive, not recruiting
St Vincent's University Hospital
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Dublin 4IrelandActive, not recruiting
University Hospital Limerick
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LimerickIrelandActive, not recruiting
Hadassah Medical Organization
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JerusalemIsraelUnknown status
Clalit Health Services
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Petach TikvahIsraelUnknown status
Safra Children's Hospital
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Tel HaShomerIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyActive, not recruiting
IRCCS Istituto Giannina Gaslini
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GenoaItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
Azienda Ospedaliera Regionale San Carlo
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PotenzaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyActive, not recruiting
Stichting Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Haga Hospital
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's-GravenhageNetherlandsActive, not recruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, not recruiting
Helse Bergen HF
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BergenNorwayActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Canterbury District Health Board
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ChristchurchNew ZealandUnknown status
Starship Children's Hospital
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GraftonNew ZealandUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Greenlane Clinical Centre
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One Tree HillNew ZealandUnknown status
Szpital Dzieciecy Polanki Im. Macieja Plazynskiego W Gdansku Sp. z o.o.
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GdanskPolandActive, not recruiting
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej Im. Dzieci Warszawy W Dziekanowie Lesnym
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LomiankiPolandActive, not recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalActive, not recruiting
Unidade Local De Saude De Santo Antonio E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalActive, not recruiting
Unidade Local de Saude de Sao Joao E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalActive, not recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenActive, not recruiting
Karolinska University Hospital
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HuddingeSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
Akron Children's Hospital
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AkronUnited StatesUnknown status
Albany Medical College, Pulmonary and Critical Care Medicine
Coordinator of this site? Confirm its status
AlbanyUnited StatesUnknown status
Michigan Medicine
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Ann ArborUnited StatesUnknown status
The Emory Clinic at Chantilly
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AtlantaUnited StatesUnknown status
Augusta University
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AugustaUnited StatesUnknown status
Children's Hospital of Colorado
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AuroraUnited StatesUnknown status
Billings Clinic
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BillingsUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
St. Luke's Cystic Fibrosis Center of Idaho
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BoiseUnited StatesUnknown status
Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center
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BostonUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
CF Therapeutics Development Center of Western New York
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BuffaloUnited StatesUnknown status
Atrium Health/Levine Children's Hospital
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CharlotteUnited StatesUnknown status
University of Virginia Health System
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CharlottesvilleUnited StatesUnknown status
Northwestern Memorial Hospital
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ChicagoUnited StatesUnknown status
Vermont Lung Center
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ColchesterUnited StatesUnknown status
Prisma Health Richland Campus
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ColumbiaUnited StatesUnknown status
Childrens Hospital University of Missouri Health Sciences Center
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ColumbiaUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
The University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Dayton Children's Hospital
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DaytonUnited StatesUnknown status
National Jewish Health
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DenverUnited StatesUnknown status
Harper University Hospital
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DetroitUnited StatesUnknown status
Cook Children's Health Care System
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Fort WorthUnited StatesUnknown status
University of Florida Shands Hospital
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GainesvilleUnited StatesUnknown status
Spectrum Health Medical Group Adult Cystic Fibrosis Care Center
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Grand RapidsUnited StatesUnknown status
New York Medical College
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HawthorneUnited StatesUnknown status
Joe DiMaggio Cystic Fibrosis & Pulmonary Center
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HollywoodUnited StatesUnknown status
Texas Children's Hospital/ Baylor College of Medicine
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HoustonUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Riley Hospital for Children at Indiana University Health
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IndianapolisUnited StatesUnknown status
The Children's Mercy Hospital
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Kansas CityUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
University of Tennessee Medical Center
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KnoxvilleUnited StatesUnknown status
University of Kentucky
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LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Miller Children's Hospital / Long Beach Memorial
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Long BeachUnited StatesUnknown status
Children's Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
University Hospital and UW Health Clinics
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MadisonUnited StatesUnknown status
Dartmouth Hitchcock
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ManchesterUnited StatesUnknown status
University of Miami Miller School of Medicine
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MiamiUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
West Virginia University
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MorgantownUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Vanderbilt University Medical Center - Nephrology Clinical Trials Center
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NashvilleUnited StatesUnknown status
Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
Tulane Medical Center
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New OrleansUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Kaiser Permanente
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OaklandUnited StatesUnknown status
Santiago Reyes, M.D.
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Oklahoma CityUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Nebraska Medical Center
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OmahaUnited StatesUnknown status
Central Florida Pulmonary Group, PA
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OrlandoUnited StatesUnknown status
Nemours Children's Specialty Care
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PensacolaUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
UPMC Children's Hospital of Pittsburgh
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PittsburghUnited StatesUnknown status
Oregon Health Science University
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PortlandUnited StatesUnknown status
Maine Medical Partners
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PortlandUnited StatesUnknown status
University of California, Davis Medical Center
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SacramentoUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
University of California San Francisco, Lung Transplant Program
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San FranciscoUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status
Sanford Children's Speciality Clinic
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Sioux FallsUnited StatesUnknown status
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic
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SpokaneUnited StatesUnknown status
Cardinal Glennon Children's Hospital - St. Louis University
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St LouisUnited StatesUnknown status
Washington University School of Medicine/St. Louis Children's Hospital
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St LouisUnited StatesUnknown status
Johns Hopkins All Children's Hospital Outpatient Care Center
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St. PetersburgUnited StatesUnknown status
SUNY Upstate Medical University
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SyracuseUnited StatesUnknown status
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
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ToledoUnited StatesUnknown status
Banner University of Arizona Medical Center
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TucsonUnited StatesUnknown status
Wake Forest Baptist Health
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Winston-SalemUnited StatesUnknown status
Umass Memorial Medical Center
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WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.