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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
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

Full criteria on ClinicalTrials.gov

Sites (139)

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

SiteCityCountrySite 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
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
Klinika Detskych Infekcnich Nemoci
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BrnoCzechiaUnknown status
Fakultni nemocnice v Motole
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PragueCzechiaUnknown status
Charité - Paediatric Pulmonology Department
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BerlinGermanyUnknown status
St. Josef Hospital
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BochumGermanyUnknown status
Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
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ErlangenGermanyUnknown status
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
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EssenGermanyUnknown status
Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie
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EssenGermanyUnknown status
Johann Wolfgang Goethe University
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FrankfurtGermanyUnknown status
Medizinische Hochschule Hannover
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HanoverGermanyUnknown status
Hannover Medical School
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HanoverGermanyUnknown status
Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
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JenaGermanyUnknown status
Johannes Gutenberg-Universitaet
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MainzGermanyUnknown status
Pneumologisches Studienzentrum Muenchen-West
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MünchenGermanyUnknown status
Klinikum Innenstadt, University of Munich
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MünchenGermanyUnknown status
Klinikum Westbrandenburg (CF)
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PotsdamGermanyUnknown status
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)
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UlmGermanyUnknown status
Universitätsklinikum Würzburg
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WürzburgGermanyUnknown status
Hospital Saint Joan de Deu
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Infantil Universitario Nino Jesus
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MadridSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Virgen de la Arrixaca
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MurciaSpainUnknown status
Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari
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SabadellSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainUnknown status
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 Hospital for Sick Children
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EdinburghUnited KingdomUnknown status
Royal Devon and Exeter Hospital
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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
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
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
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PenarthUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown 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 Health Ireland at Temple Street
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DublinIrelandUnknown status
Children's Health Ireland at Tallaght
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DublinIrelandUnknown status
University Hospital Limerick (Adults)
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LimerickIrelandUnknown status
University Hospital Limerick (Pediatrics)
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LimerickIrelandUnknown status
Hadassah University Hospital - Mount Scopus
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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
Greenlane Clinical Centre
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AucklandNew ZealandUnknown status
Starship Children's Hospital
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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
Hospital De Santa Maria
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LisbonPortugalUnknown status
Hospital Sao Joao
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PortoPortugalUnknown status
CHP - Hospital de Santo Antonio
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PortoPortugalUnknown 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
Albany Medical College
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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
Boston Children's Hospital
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BostonUnited StatesUnknown status
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
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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
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited StatesUnknown status
Cleveland Clinic CF
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ClevelandUnited StatesUnknown status
Vermont Lung Center
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ColchesterUnited 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
Driscoll Children's Hospital
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Corpus ChristiUnited 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
Inova Fairfax
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Falls ChurchUnited 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
Helen DeVos Children's Hospital CF Center
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Grand RapidsUnited 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
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited 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
Arkansas Children's Hospital
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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
Kosair Charities Pediatric Clinical Research Unit
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LouisvilleUnited StatesUnknown status
University of Wisconsin Hospital and Clinics
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MadisonUnited StatesUnknown status
Dartmouth-Hitchcock Manchester
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ManchesterUnited StatesUnknown status
Children's Foundation Research Center / Le Bonheur Children's Hospital
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MemphisUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited 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
Kaiser Permanente
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OaklandUnited StatesUnknown status
Nebraska Medical Center
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OmahaUnited StatesUnknown status
Nemours Children's Hospital
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OrlandoUnited StatesUnknown status
Central Florida Pulmonary Group, PA
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OrlandoUnited 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
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 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
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
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
New York Medical College
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ValhallaUnited 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.