Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del
NCT ID: NCT05331183
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
297 participants
INTERVENTIONAL
2022-11-23
2027-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ELX/TEZ/IVA
Part A: Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening for 96 weeks.
Part B: Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening for an additional 96 weeks.
ELX/TEZ/IVA
Fixed-dose combination (FDC) tablets for oral administration.
IVA
Tablets for oral administration.
Interventions
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ELX/TEZ/IVA
Fixed-dose combination (FDC) tablets for oral administration.
IVA
Tablets for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
6 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Medizinische Universität Innsbruck - Heilstättenschule Universitätsklinik
Innsbruck, , Austria
CUB Hôpital Erasme
Brussels, , Belgium
UZ Brussel - Campus Jette
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Universite Catholique de Louvain - Pulmonology
Woluwe-Saint-Lambert, , Belgium
Stollery Children's Hospital
Edmonton, , Canada
Le Centre de recherche du CHUM (CRCHUM)
Montreal, , Canada
McGill University Health Centre, Glen Site, Montreal Children's Hospital
Montreal, , Canada
Hospital for Sick Children - Pulmonology
Toronto, , Canada
British Columbia Children's Hospital
Vancouver, , Canada
St. Paul's Hospital - Pulmonology
Vancouver, , Canada
Klinika Detskych Infekcnich Nemoci
Brno, , Czechia
Motol University Hospital
Prague, , Czechia
Hopital Femme Mere-Enfant
Bron, , France
Centre Hospitalier Intercommunal Creteil - Pulmonology
Créteil, , France
Institut Cœur Poumon, CHU de Lille
Lille, , France
Hopital Nord
Marseille, , France
Hopital Arnaud de Villeneuve - Service de Pneumologie et Maladies Respiratoires
Montpellier, , France
Hôpital Nord Laennec
Nantes, , France
CHU de Nice - Hôpital Pasteur 2
Nice, , France
Hopital Cochin - Pulmonology
Paris, , France
Hopital Necker Enfants Malades - Pulmonology
Paris, , France
Hopital Robert Debre - Pulmonology
Paris, , France
Hôpital Lyon Sud - Pulmonology
Pierre-Bénite, , France
Hôpital américain de Reims - Département de pédiatrie A
Reims, , France
Hôpital Sud - Rennes
Rennes, , France
Centre de Perharidy, Roscoff
Roscoff, , France
Hopital Larrey
Toulouse, , France
Hopital Bretonneau
Tours, , France
Charité - Paediatric Pulmonology Department
Berlin, , Germany
University Hospital Cologne (Koeln) - CF-Studienzentrum
Cologne, , Germany
Ruhrlandklinik
Essen, , Germany
Klinikum der Johann-Wolfgang-Goethe Universitaet - Pulmonology
Frankfurt, , Germany
Justus-Liebig-Universität Gießen
Giessen, , Germany
Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie
Halle, , Germany
Medizinische Hochschule Hannover - Clinic for Pediatric Pneumology, Allergology and Neonatology, CF-Centre
Hanover, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Mukoviszidose-Zentrum am Universitätsklinikum Jena
Jena, , Germany
Johannes Gutenberg-Universitaet
Mainz, , Germany
Dr. von Haunersches Kinderspital - Pulmonology
München, , Germany
Lungenheilkunde Munchen - Pasing
München, , Germany
Klinik für Kinder- und Jugendmedizin
Münster, , Germany
Klinikum Westbrandenburg (CF)
Potsdam, , Germany
National Koranyi Institute for TBC and Pulmonology
Budapest, , Hungary
Azienda Ospedaliero Universitaria delle Marche
Ancona, , Italy
Azienda Ospedaliero Universitaria Ospedale Meyer
Florence, , Italy
IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico
Genova, , Italy
Policlinico Universitario G. Martino
Messina, , Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliero Universitaria Federico II Napoli
Naples, , Italy
Azienda Ospedaliero Universitaria (AOU) San Luigi Gonzaga
Orbassano, , Italy
Azienda Ospedaliera Regionale 'San Carlo', Potenza
Potenza, , Italy
IRCSS Ospedale Pediatrico Bambino Gesu - Pulmonology
Rome, , Italy
Azienda Ospedaliera di Verona - Ospedale Civile Maggiore
Verona, , Italy
Amsterdam UMC - locatie AMC - Afdeling Longgeneeskunde
Amsterdam, , Netherlands
Radboud University Medical Center - Pulmonology
Nijmegen, , Netherlands
Erasmus Medisch Centrum - Pulmonology
Rotterdam, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
UMCU, Locatie Wilhelmina Kinderziekenhuis
Utrecht, , Netherlands
Oslo University Hospital, Department of Paediatric Medicine
Oslo, , Norway
Pediatric Hospital Polanki named of Maciej Płażyński
Gdansk, , Poland
Instytut Matki i Dziecka, Klinika Mukowiscydozy IMiD, Oddział Chorób Płuc SZPZOZ im.Dzieci Warszawy w Dziekanowie Leśnym
Łomianki, , Poland
Unidade Local de Saúde de Santa Maria, E.P.E. - Pulmonology
Lisbon, , Portugal
Hospital de Cruces
Barakaldo, , Spain
Hospital Saint Joan de Deu
Barcelona, , Spain
Hospital Universitari Vall d´Hebron Servicio de Broncoscopia
Barcelona, , Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Universitario 12 de Octubre - Pulmonology
Madrid, , Spain
Hospital Universitario Ramon y Cajal - Pulmonology
Madrid, , Spain
La Paz Infantil
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Institut d´Investigacio i Innovacio Parc Tauli
Sabadell, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario y Politecnico La Fe - Pulmonology
Valencia, , Spain
Sahlgrenska Universitetssjukhuset - Göteborg CF-center
Gothenburg, , Sweden
Karolinska University Hospital - Pulmonology
Stockholm, , Sweden
Kinderspital Zuerich
Zurich, , Switzerland
Countries
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Other Identifiers
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2021-005914-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-515637-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
VX21-445-125
Identifier Type: -
Identifier Source: org_study_id
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