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NCT05331183Active, not recruitingPhase 3

Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
297 (actual)
First submitted
8 Apr 2022
Start date
23 Nov 2022
Primary completion date
6 Apr 2027
Lead sponsor
Vertex Pharmaceuticals Incorporated
NCT number
NCT05331183
EU CT number
2024-515637-14-00
EudraCT number
2021-005914-33

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 297
  • From 23 Nov 2022 to the primary completion date, 6 Apr 2027
  • 77 sites in 15 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 study drug intolerance in the parent study

Other

  • Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • Part A: Completed study drug treatment in parent study or had study drug interruption(s) in parent study but 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 completed study visits up to the last scheduled visit of the treatment period of Part A

Age in the registry: 6 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (77)

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

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaCompleted
Hopital Erasme
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AnderlechtBelgiumActive, not recruiting
Antwerp University Hospital
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EdegemBelgiumActive, 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
Stollery Children'S Hospital
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Le Centre de recherche du CHUM (CRCHUM)
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MontrealCanadaUnknown status
McGill University Health Centre, Glen Site, Montreal Children's Hospital
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MontrealCanadaUnknown status
Hospital for Sick Children - Pulmonology
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TorontoCanadaUnknown status
St. Paul's Hospital - Pulmonology
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VancouverCanadaUnknown status
British Columbia Children'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 Motol a Homolka
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PragueCzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
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EssenGermanyCompleted
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyCompleted
Justus-Liebig-Universitaet Giessen
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GiessenGermanyCompleted
Universitaetsklinikum Halle (Saale) AöR
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Halle SaaleGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Universitaetsklinikum Jena KöR
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JenaGermanyCompleted
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyCompleted
Universitaetsklinikum Muenster AöR
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MuensterGermanyCompleted
Pneumological Study Center Munich-West
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MunichGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Klinikum Ernst von Bergmann gGmbH
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PotsdamGermanyCompleted
Hospital Universitario de Cruces
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BarakaldoSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainActive, not recruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainActive, not recruiting
Hospital Infantil Universitario Nino Jesus
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, 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
Fondation Ildys
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Brest Cedex 2FranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Intercommunal Créteil
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CréteilFranceCompleted
Hopital Cardiologique
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Lille CedexFranceCompleted
Centre Hospitalier Regional De Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire Reims
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ReimsFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceCompleted
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryActive, not recruiting
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
Azienda Ospedaliera Universitaria Gaetano Martino Messina
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MessinaItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, 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
Ospedale Pediatrico Bambino Gesù
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyActive, not recruiting
VUMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Radboud universitair medisch centrum Stichting
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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
Oslo University Hospital HF
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OsloNorwayCompleted
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
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenCompleted
Karolinska University Hospital
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HuddingeSwedenCompleted

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