Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation

PHASE3CompletedINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

May 9, 2022

Primary Completion Date

July 5, 2023

Study Completion Date

July 5, 2023

Conditions
Cystic Fibrosis
Interventions
DRUG

ELX/TEZ/IVA

Fixed-dose combination (FDC) tablets for oral administration.

DRUG

IVA

Tablet for oral administration.

OTHER

Placebo (matched to ELX/TEZ/IVA)

Placebo matched to ELX/TEZ/IVA for oral administration.

OTHER

Placebo (matched to IVA)

Placebo matched to IVA for oral administration.

Trial Locations (90)

Unknown

Medizinische Universität Innsbruck, Innsbruck

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital, Edegem

Universitair Ziekenhuis Gent, Ghent

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

Stollery Children's Hospital, Edmonton

Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu, Montreal

McGill University Health Centre, Glen Site, Montreal Children's Hospital, Montreal

The Hospital for Sick Children, Toronto

British Columbia Children's Hospital, Vancouver

St. Paul's Hospital, Vancouver

Klinika Detskych Infekcnich Nemoci, Brno

Fakultni nemocnice v Motole, Prague

CHU Lyon - Hopital Femme Mere-Enfant, Bron

Centre Hospitalier Intercommunal Creteil, Créteil

Institut Cœur Poumon, CHU de Lille, Lille

CHU Marseille - Hopital Nord, Marseille

Hopital Arnaud de Villeneuve, Montpellier

Centre Hospitalier Universitaire De Nantes - G. R. Laennec, Nantes

Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur, Nice

Hopital Cochin, Paris

Hopital Necker, Enfants Malades, Paris

Hopital Robert Debre, Paris

Hopital Haut-Leveque - CRCM Adulte, Pessac

Centre Hospitalier Lyon Sud, Pierre-Bénite

Centre Hospitalier Universitaire De Reims, Hopital Sebastopol, Reims

CHU de Rennes - Hôpital Sud, Rennes

Centre de Perharidy, Roscoff

CHU de Toulouse - Hopital Larre, Toulouse

Hopital Bretonneau, Tours

Charite Paediatric Pulmonology Department, Berlin

Universitaetsklinkum Koeln, CF-Studienzentrum, Cologne

Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital, Erlangen

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Johann Wolfgang Goethe University, Frankfurt

Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin, Giessen

Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie, Halle

Hannover Medical School, Hanover

Medizinische Hochschule Hannover, Hanover

Universitaetsklinikum Jena, Mukoviszidose-Zentrum, Jena

Johannes Gutenberg-Universitaet, Mainz

Dr. von Haunersches Kinderspital, München

Klinikum Innenstadt, University of Munich, München

Pneumologisches Studienzentrum Muenchen-West, München

Klinik fur Kinder- und Jugendmedizin, Universitatsklinikum Munster, Münster

Klinikum Westbrandenburg (CF), Potsdam

Universitätsklinikum Tübingen Klinik für Kinder- und Jugendmedizin, Tübingen

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF), Ulm

Universitätsklinikum Würzburg, Würzburg

National Koranyi Institute for TBC and Pulmonology, Budapest

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer, Florence

IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico, Genova

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Azienda Ospedaliera Universitaria Federico II (Adults), Naples

Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica, Orbassano

Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo, Potenza

Ospedale Pediatrico Bambino Gesu, Rome

Azienda Ospedaliera di Verona - Ospedale Civile Maggiore, Verona

Academisch Medisch Centrum (Academic Medical Centre), Amsterdam

UMC St. Radboud, Nijmegen

Erasmus Medical Center, Rotterdam

HagaZiekenhuis van den Haag, The Hague

Universitair Medisch Centrum Utrecht, Utrecht

Oslo University Hospital, Department of Paediatric Medicine, Oslo

Pediatric Hospital Polanki named of Maciej Płażyński, Gdansk

Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój

Instytut Matki i Dziecka, Klinika Mukowiscydozy IMiD, Oddział Chorób Płuc SZPZOZ im.Dzieci Warszawy w Dziekanowie Leśnym, Łomianki

Hospital de Santa Maria, Lisbon

Hospital Sao Joao, Porto

Hospital de Cruces, Barakaldo

Hospital Saint Joan de Deu, Barcelona

Hospital Universitari Vall d Hebron, Barcelona

Hospital Universitari Vall d´Hebron Servicio de Broncoscopia, Barcelona

Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera

Hospital Infantil Universitario Nino Jesus, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario Infantil La Paz, Madrid

Hospital Universitario Ramon y Cajal, Madrid

Hospital Virgen de la Arrixaca, Murcia

Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari, Sabadell

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitario y Politecnico La Fe, Valencia

Sahlgrenska Universitetssjukhuset, Gothenburg

Karolinska Universitetssjukhuset, Huddinge, Stockholm

Kinderspital Zuerich, Zurich

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY