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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
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

Full criteria on ClinicalTrials.gov

Sites (170)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Graz
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GrazAustriaUnknown status
Medizinische Universität Innsbruck
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InnsbruckAustriaUnknown status
Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde
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SalzburgAustriaUnknown status
Medizinische Universität Wien
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ViennaAustriaUnknown status
Abteilung fuer Pulmologie Klinikum Wels-Grieskirchen
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WelsAustriaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
The Prince Charles Hospital
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ChermsideAustraliaUnknown status
Alfred Hospital
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Melbourne, VICAustraliaUnknown status
Institute for Respiratory Health
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NedlandsAustraliaUnknown status
Telethon Kids Institute
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NedlandsAustraliaUnknown status
The Royal Children's Hospital
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Parkville, VICAustraliaUnknown status
Sydney Children's Hospital
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RandwickAustraliaUnknown 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
Cliniques Universitaires de Bruxelles Hopital Erasme
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BrusselsBelgiumUnknown status
Universitair Ziekenhuis Brussel - Campus Jette
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BrusselsBelgiumUnknown status
Universitair Ziekenhuis Gent
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GhentBelgiumUnknown status
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
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LeuvenBelgiumUnknown status
Cliniques universitaires Saint-Luc
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Woluwe-Saint-LambertBelgiumUnknown status
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
St. Michael's Hospital
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TorontoCanadaUnknown status
St. Paul's Hospital
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VancouverCanadaUnknown status
British Columbia Children's Hospital
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VancouverCanadaUnknown status
Lindenhofspital - Quartier Bleu
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BernSwitzerlandUnknown status
Réseau Hospitalier Neuchâtelois
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NeuchâtelSwitzerlandUnknown status
Kinderspital Zuerich
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ZurichSwitzerlandUnknown status
Charité - Paediatric Pulmonology Department
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BerlinGermanyUnknown status
Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
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ErlangenGermanyUnknown status
Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie
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EssenGermanyUnknown status
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
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EssenGermanyUnknown status
Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin
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GiessenGermanyUnknown status
Pneumologisches Studienzentrum Muenchen-West
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MünchenGermanyUnknown status
Aarhus University Hospital
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AarhusDenmarkUnknown status
Juliane Marie Center, Rigshospitalet
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CopenhagenDenmarkUnknown status
Groupe Hospitaler Pellegrin, CHU De Bordeaux
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BordeauxFranceUnknown status
CHU Lyon - Hopital Femme Mere-Enfant
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BronFranceUnknown status
Centre Hospitalier Intercommunal Créteil
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CréteilFranceUnknown status
Institut Cœur Poumon CHU de Lille
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LilleFranceUnknown status
Hôpital Arnaud de Villeneuve
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MontpellierFranceUnknown status
Centre Hospitalier Universitaire De Nantes - G. R. Laennec
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NantesFranceUnknown status
Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur
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NiceFranceUnknown status
Hopital Necker Enfants Malades
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ParisFranceUnknown status
Hôpital Cochin
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ParisFranceUnknown status
Hopital Robert Debre
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ParisFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
Centre de Perharidy
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RoscoffFranceUnknown status
CHU de Rouen - Hopital Charles Nicolle
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Rouen Cedex, Seine MaritimeFranceUnknown status
Hôpital de Hautepierre, AX5
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StrasbourgFranceUnknown status
Hopital Foch (Suresnes), Hopital Foch, Adultes
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SuresnesFranceUnknown status
Hopital Bretonneau
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ToursFranceUnknown status
Centre hospitalier universitaire de Nancy, Hôpital de Braboi
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Vandœuvre-lès-NancyFranceUnknown status
Birmingham Children's Hospital
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BirminghamUnited KingdomUnknown status
Royal Papworth Hospital NHS Foundation Trust
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CambridgeUnited 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
Royal Brompton Hospital
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LondonUnited 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 Manchester Children's Hospital
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ManchesterUnited KingdomUnknown status
Wythenshawe Hospital
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ManchesterUnited KingdomUnknown status
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
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PenarthUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown status
General Hospital of Thessaloniki "Papanikolaou"
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Pilea ChortiatisGreeceUnknown status
General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki
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ThessalonikiGreeceUnknown status
National Koranyi Institute for TBC and Pulmonology
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BudapestHungaryUnknown status
Pulmonology Institute Torokbalint
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TörökbálintHungaryUnknown status
Cork University Hospital
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CorkIrelandUnknown status
St Vincent's University Hospital
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DublinIrelandUnknown status
Children's Health Ireland at Crumlin
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DublinIrelandUnknown status
Children's University Hospital, Dublin
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DublinIrelandUnknown status
Children's Health Ireland at Tallaght
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DublinIrelandUnknown status
University Hospital Limerick (Pediatrics)
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LimerickIrelandUnknown status
University Hospital Limerick (Adults)
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LimerickIrelandUnknown status
Hadassah Medical Organization
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JerusalemIsraelUnknown status
Schneider Children's Medical Center of Israel
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Petach TikvahIsraelUnknown status
Sheba Medical Center - The Edmond and Lili Safra Children's Hospital
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Tel HaShomerIsraelUnknown status
Azienda Ospedaliero Universitaria Ospedale Riuniti
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AnconaItalyUnknown status
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
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FlorenceItalyUnknown status
IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico
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GenovaItalyUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyUnknown status
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
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MilanItalyUnknown status
Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica
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OrbassanoItalyUnknown status
Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo
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PotenzaItalyUnknown status
Azienda Ospedaliera di Verona - Ospedale Civile Maggiore
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VeronaItalyUnknown status
Academisch Medisch Centrum (Academic Medical Centre)
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AmsterdamNetherlandsUnknown status
UMC St Radboud
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NijmegenNetherlandsUnknown status
Erasmus Medical Center
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RotterdamNetherlandsUnknown status
HagaZiekenhuis van Den Haag
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The HagueNetherlandsUnknown status
University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis
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UtrechtNetherlandsUnknown status
Haukeland Universitetssjukehus (CF)
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BergenNorwayUnknown status
Oslo University Hospital, Department of Paediatric Medicine
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OsloNorwayUnknown status
Starship Children's Hospital
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AucklandNew ZealandUnknown status
Greenlane Clinical Centre
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AucklandNew ZealandUnknown status
Canterbury Respiratory Research Group
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Christchurch HospitalNew ZealandUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Pediatric Hospital Polanki named of Maciej Płażyński
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GdanskPolandUnknown status
Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY
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ŁomiankiPolandUnknown status
Institute of Tuberculosis and Lung Diseases
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Rabka-ZdrójPolandUnknown status
Sahlgrenska Universitetssjukhuset
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GothenburgSwedenUnknown status
Lund University Skanes Universitetssjukhus
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MalmöSwedenUnknown status
Karolinska universitetssjukhuset - Huddinge
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StockholmSwedenUnknown status
Akron Children's Hospital
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AkronUnited StatesUnknown status
Michigan Medicine
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Ann ArborUnited StatesUnknown status
The Emory Clinic at Chantilly
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AtlantaUnited 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 Rsearch 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
University of Virginia Health System
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CharlottesvilleUnited StatesUnknown status
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited 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
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
Spectrum Health Medical Group Adult Cystic Fibrosis Care Center
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Grand RapidsUnited 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
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Nemours Children's Specialty Care
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JacksonvilleUnited StatesUnknown status
The Children's Mercy Hospital
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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
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
University of Miami Miller School of Medicine
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MiamiUnited 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
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NashvilleUnited StatesUnknown status
Yale New Haven Hospital
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New HavenUnited StatesUnknown status
Northwell Health/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
Children's Hospital of The King's Daughters
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NorfolkUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Santiago Reyes, M.D.
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Oklahoma CityUnited StatesUnknown status
Children's Hospital of Orange County
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OrangeUnited StatesUnknown status
Central Florida Pulmonary Group, PA
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OrlandoUnited StatesUnknown status
Nemours Children's Specialty Care, Pensacola
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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 - Primary Children's Medical Center
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Salt Lake CityUnited 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
Washington University School of Medicine
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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.