Phase
Condition
Cystic Fibrosis
Scar Tissue
Lung Disease
Treatment
Placebo (matched to VX-121/TEZ/D-IVA)
IVA
Placebo (matched to ELX/TEZ/IVA)
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
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/IVAand no F508del mutation
Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted meanfor age, sex, and height for participants currently receiving CFTR protein modulatortherapy; FEV1 >=40% and <=80% for participants not currently receiving CFTR proteinmodulator therapy
Exclusion
Key Exclusion Criteria:
History of solid organ or hematological transplantation
Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child PughScore 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
Lung infection with organisms associated with a more rapid decline in pulmonarystatus
Pregnant or breast-feeding females
Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Royal Prince Alfred Hospital
Camperdown,
AustraliaSite Not Available
The Prince Charles Hospital
Chermside,
AustraliaSite Not Available
Alfred Hospital
Melbourne, VIC,
AustraliaSite Not Available
Institute for Respiratory Health
Nedlands,
AustraliaSite Not Available
Telethon Kids Institute
Nedlands,
AustraliaSite Not Available
The Royal Children's Hospital
Parkville, VIC,
AustraliaSite Not Available
Sydney Children's Hospital
Randwick,
AustraliaSite Not Available
Mater Adult Hospital
South Brisbane,
AustraliaSite Not Available
Queensland Children's Hospital
South Brisbane,
AustraliaSite Not Available
Westmead Hospital
Westmead,
AustraliaSite Not Available
University of Graz
Graz,
AustriaSite Not Available
Medizinische Universität Innsbruck
Innsbruck,
AustriaSite Not Available
Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde
Salzburg,
AustriaSite Not Available
Medizinische Universität Wien
Vienna,
AustriaSite Not Available
Abteilung fuer Pulmologie Klinikum Wels-Grieskirchen
Wels,
AustriaSite Not Available
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussel,
BelgiumSite Not Available
Universitair Ziekenhuis Brussel - Campus Jette
Brussel,
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent,
BelgiumSite Not Available
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven,
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert,
BelgiumSite Not Available
University of Calgary Medical Clinic of the Foothills Medical Centre
Calgary,
CanadaSite Not Available
Stollery Children's Hospital
Edmonton,
CanadaSite Not Available
St. Joseph's Health Care London
London,
CanadaSite Not Available
Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu
Montreal,
CanadaSite Not Available
McGill University Health Centre, Glen Site, Montreal Children's Hospital
Montréal,
CanadaSite Not Available
Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval
Québec,
CanadaSite Not Available
St. Michael's Hospital
Toronto,
CanadaSite Not Available
British Columbia Children's Hospital
Vancouver,
CanadaSite Not Available
St. Paul's Hospital
Vancouver,
CanadaSite Not Available
Aarhus University Hospital
Aarhus,
DenmarkSite Not Available
Juliane Marie Center, Rigshospitalet
Copenhagen,
DenmarkSite Not Available
Groupe Hospitaler Pellegrin, CHU De Bordeaux
Bordeaux cedex,
FranceSite Not Available
CHU Lyon - Hopital Femme Mere-Enfant
Bron Cedex,
FranceSite Not Available
Centre Hospitalier Intercommunal Creteil
Créteil,
FranceSite Not Available
Institut Cœur Poumon, CHU de Lille
Lille,
FranceSite Not Available
Hopital Arnaud de Villeneuve
Montpellier Cedex 5,
FranceSite Not Available
Centre Hospitalier Universitaire De Nantes - G. R. Laennec
Nantes,
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur
Nice,
FranceSite Not Available
Hopital Cochin
Paris,
FranceSite Not Available
Hopital Robert Debre
Paris,
FranceSite Not Available
Hopital Necker, Enfants Malades
Paris Cedex 15,
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre-Bénite,
FranceSite Not Available
Centre de Perharidy
Roscoff cedex,
FranceSite Not Available
CHU de Rouen - Hopital Charles Nicolle
Rouen Cedex, Seine Maritime,
FranceSite Not Available
Hôpital de Hautepierre, AX5
Strasbourg,
FranceSite Not Available
Hopital Foch (Suresnes), Hopital Foch, Adultes
Suresnes,
FranceSite Not Available
Centre Hospitalier Universitaire De Nantes - G. R. Laennec
Tissot, Adrien,
FranceSite Not Available
Hopital Bretonneau
Tours,
FranceSite Not Available
Centre hospitalier universitaire de Nancy, Hôpital de Braboi
Vandoeuvre Les Nancy,
FranceSite Not Available
Charite Paediatric Pulmonology Department
Berlin,
GermanySite Not Available
Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
Erlangen,
GermanySite Not Available
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
Essen,
GermanySite Not Available
Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie
Essen,
GermanySite Not Available
Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin
Gießen,
GermanySite Not Available
Pneumologisches Studienzentrum Muenchen-West
Muenchen,
GermanySite Not Available
General Hospital of Thessaloniki "Papanikolaou"
Pilea Chortiatis,
GreeceSite Not Available
General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki
Thessaloníki,
GreeceSite Not Available
National Koranyi Institute for TBC and Pulmonology
Budapest,
HungarySite Not Available
Pulmonology Institute Torokbalint
Torokbalint,
HungarySite Not Available
Cork University Hospital
Cork,
IrelandSite Not Available
Children's Health Ireland at Crumlin
Dublin,
IrelandSite Not Available
Children's Health Ireland at Tallaght
Dublin,
IrelandSite Not Available
Children's University Hospital, Dublin
Dublin,
IrelandSite Not Available
St. Vincent's University Hospital
Dublin,
IrelandSite Not Available
University Hospital Limerick (Adults)
Limerick,
IrelandSite Not Available
University Hospital Limerick (Pediatrics)
Limerick,
IrelandSite Not Available
Hadassah Medical Organization
Jerusalem,
IsraelSite Not Available
Schneider Children's Medical Center of Israel
Petach Tikvah,
IsraelSite Not Available
Sheba Medical Center - The Edmond and Lili Safra Children's Hospital
Tel HaShomer,
IsraelSite Not Available
Azienda Ospedaliero Universitaria Ospedale Riuniti
Ancona,
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Firenze,
ItalySite Not Available
IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico
Genova,
ItalySite Not Available
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan,
ItalySite Not Available
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano,
ItalySite Not Available
Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica
Orbassano,
ItalySite Not Available
Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo
Potenza,
ItalySite Not Available
Azienda Ospedaliera di Verona - Ospedale Civile Maggiore
Verona,
ItalySite Not Available
Academisch Medisch Centrum (Academic Medical Centre)
Amsterdam,
NetherlandsSite Not Available
HagaZiekenhuis van den Haag
Den Haag,
NetherlandsSite Not Available
University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis
Heidelberglaan,
NetherlandsSite Not Available
UMC St. Radboud
Nijmegen,
NetherlandsSite Not Available
Erasmus Medical Center
Rotterdam,
NetherlandsSite Not Available
University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis
Utrecht,
NetherlandsSite Not Available
Greenlane Clinical Centre
Auckland,
New ZealandSite Not Available
Starship Children's Hospital
Auckland,
New ZealandSite Not Available
Canterbury Respiratory Research Group
Christchurch Hospital,
New ZealandSite Not Available
Waikato Hospital
Hamilton,
New ZealandSite Not Available
Haukeland Universitetssjukehus (CF)
Bergen,
NorwaySite Not Available
Oslo University Hospital, Department of Paediatric Medicine
Oslo,
NorwaySite Not Available
Pediatric Hospital Polanki named of Maciej Płażyński
Gdańsk,
PolandSite Not Available
Institute of Tuberculosis and Lung Diseases
Rabka Zdrój,
PolandSite Not Available
Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY
Łomianki,
PolandSite Not Available
Sahlgrenska Universitetssjukhuset
Göteborg,
SwedenSite Not Available
Lund University Skanes Universitetssjukhus
Malmoe,
SwedenSite Not Available
Karolinska Universitetssjukhuset, Huddinge
Stockholm,
SwedenSite Not Available
Lindenhofspital - Quartier Bleu
Bern,
SwitzerlandSite Not Available
Réseau Hospitalier Neuchâtelois
Neuchâtel,
SwitzerlandSite Not Available
Kinderspital Zuerich
Zurich,
SwitzerlandSite Not Available
Kinderspital Zuerich
Zürich,
SwitzerlandSite Not Available
Birmingham Children's Hospital
Birmingham,
United KingdomSite Not Available
Royal Papworth Hospital NHS Foundation Trust
Cambridge,
United KingdomSite Not Available
Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow,
United KingdomSite Not Available
Leeds General Infirmary
Leeds,
United KingdomSite Not Available
St. James University Hospital
Leeds,
United KingdomSite Not Available
King's College Hospital
London,
United KingdomSite Not Available
Royal Brompton Hospital
London,
United KingdomSite Not Available
St. Bartholomew's Hospital
London,
United KingdomSite Not Available
Royal Manchester Children's Hospital
Manchester,
United KingdomSite Not Available
Wythenshawe Hospital
Manchester,
United KingdomSite Not Available
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
Penarth,
United KingdomSite Not Available
Southampton General Hospital
Southampton,
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
Banner University of Arizona Medical Center
Tucson, Arizona 85724
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
Children's Hospital Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
Children's Hospital of Orange County
Orange, California 92868
United StatesSite Not Available
University of California Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Children's Hospital of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
National Jewish Health
Denver, Colorado 80206
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Nemours Children's Specialty Care
Jacksonville, Florida 32207
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Central Florida Pulmonary Group, PA
Orlando, Florida 32803
United StatesSite Not Available
Nemours Children's Specialty Care, Pensacola
Pensacola, Florida 32514
United StatesSite Not Available
Johns Hopkins All Children's Hospital Outpatient Care Center
Saint Petersburg, Florida 33701
United StatesSite Not Available
The Emory Clinic at Chantilly
Atlanta, Georgia 30324
United StatesSite Not Available
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho 83702
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Tulane Medical Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Maine Medical Partners
Portland, Maine 04102
United StatesSite Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
Boston, Massachusetts 02114
United StatesSite Not Available
UMass Memorial Medical Center
Worcester, Massachusetts 01655
United StatesSite Not Available
Michigan Medicine
Ann Arbor, Michigan 48109-5212
United StatesSite Not Available
Harper University Hospital
Detroit, Michigan 48201
United StatesSite Not Available
Spectrum Health Medical Group Adult Cystic Fibrosis Care Center
Grand Rapids, Michigan 49546
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
The Children's Mercy Hospital
Kansas City, Missouri 64108
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Billings Clinic
Billings, Montana 59101
United StatesSite Not Available
Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
CF Therapeutics Development Center of Western New York
Buffalo, New York 14203
United StatesSite Not Available
Northwell Health- Long Island Jewish Medical Center
New Hyde Park, New York 11040
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem, North Carolina 27104
United StatesSite Not Available
Akron Children's Hospital
Akron, Ohio 44308
United StatesSite Not Available
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Dayton Children's Hospital
Dayton, Ohio 45404
United StatesSite Not Available
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio 43606
United StatesSite Not Available
Santiago Reyes, M.D.
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
Prisma Health Richland Campus
Columbia, South Carolina 29203
United StatesSite Not Available
Sanford Children's Speciality Clinic
Sioux Falls, South Dakota 57105
United StatesSite Not Available
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
The University of Texas Southwestern Medical Center
Dallas, Texas 75390-8558
United StatesSite Not Available
Cook Children's Health Care System
Fort Worth, Texas 76104
United StatesSite Not Available
University of Utah - Primary Children's Medical Center
Salt Lake City, Utah 84132
United StatesSite Not Available
Vermont Lung Center
Colchester, Vermont 05446
United StatesSite Not Available
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
Children's Hospital of the King's Daughters
Norfolk, Virginia 23507
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic
Spokane, Washington 99204
United StatesSite Not Available
West Virginia University
Morgantown, West Virginia 26506
United StatesSite Not Available
University Hospital and UW Health Clinics
Madison, Wisconsin 53792
United StatesSite Not Available
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