A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
NCT ID: NCT03447249
Last Updated: 2020-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
385 participants
INTERVENTIONAL
2018-03-07
2019-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants who received placebo matched to VX-659/TEZ/IVA for 24 weeks in the TC treatment period.
Placebo
Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
VX-659/TEZ/IVA TC
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
VX-659/TEZ/IVA
Participants received VX-659/TEZ/IVA orally once daily in the morning.
IVA
Participants received IVA orally once daily in the evening.
Interventions
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VX-659/TEZ/IVA
Participants received VX-659/TEZ/IVA orally once daily in the morning.
IVA
Participants received IVA orally once daily in the evening.
Placebo
Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height
Exclusion Criteria
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation
12 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Hartford Health
Hartford, Connecticut, United States
Yale New Haven Medical Center
New Haven, Connecticut, United States
University of Miami/ Miller School of Medicine
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Arnold Palmer Hospital
Orlando, Florida, United States
Johns Hopkins All Children's Hospital Outpatient Care Center
St. Petersburg, Florida, United States
St. Luke's CF Center of Idaho
Boise, Idaho, United States
Cystic Fibrosis Center of Chicago
Glenview, Illinois, United States
Advocate Children's Hospital - Park Ridge/ North Suburban Pulmonary and Critical Care Consultants
Niles, Illinois, United States
Indiana Clinical Research Center, IU Health University Hospital
Indianapolis, Indiana, United States
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kentucky Clinic
Lexington, Kentucky, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital CF Center
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University School of Medicine/ St. Louis Children's Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon
Lebanon, New Hampshire, United States
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Albany Medical College
Albany, New York, United States
Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo
Buffalo, New York, United States
Northwell Health, Long Island Jewish Medical Center
New Hyde Park, New York, United States
Columbia University Medical Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Clinical Research of Charlotte
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Respiratory Diseases of Children and Adolescents
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sanford Research/ USD
Sioux Falls, South Dakota, United States
University of Tennessee Medical Center - Adult Cystic Fibrosis Clinic
Knoxville, Tennessee, United States
Children's Foundation Research Center/ Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah / Primary Children's Medical Center
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Pediatric Pulmonary & Allergy/Immunology Clinic
Spokane, Washington, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Prince Charles Hospital
Chermside, , Australia
Royal Brisbane & Women's Hospital
Herston, , Australia
Institute for Respiratory Health Inc./ Sir Charles Gairdner Hospital
Nedlands, , Australia
John Hunter Hospital & Hunter Medical Research Institute
New Lambton Heights, , Australia
Sydney Children's Hospital, Randwick
Randwick, , Australia
Princess Margaret Hospital for Children
Subiaco, , Australia
Stollery Children's Hospital
Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
St. Michael's Hospital
Toronto, , Canada
Juliane Marie Center, Rigshospitalet
Copenhagen, , Denmark
Charite Paediatric Pulmonology Department
Berlin, , Germany
University Hospital Cologne
Cologne, , Germany
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
Essen, , Germany
Clinic of J.W Goethe University
Frankfurt, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Mukeviszidose-Zentrum am Universitatsklinikum Jena, Klinik fuer Kinder - und Jugendmedizin
Jena, , Germany
Universitatsklinikum Schleswig-Holstein, Klinik fur Kinder- und Jugendmedizin
Lübeck, , Germany
Klinikum Innenstadt, University of Munich
München, , Germany
Pneumologische Praxis Pasing
München, , Germany
Beaumont Hospital
Dublin, , Ireland
Children's University Hospital Temple Street
Dublin, , Ireland
Cork University Hospital
Dublin, , Ireland
Our Lady's Children's Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
National University of Ireland
Galway, , Ireland
University Hospital Limerick
Limerick, , Ireland
Lady Davis Carmel Medical Center
Haifa, , Israel
Pediatric Pulmonary Unit Rambam Medical Center
Haifa, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Instytut Matki i Dziecka
Warsaw, , Poland
Hospital Universitari Vall d Hebron
Barcelona, , Spain
Hospital Universitari Vall d'Hebron Servicio de Broncoscopia
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Infantil La Paz
Madrid, , Spain
Coporacio Sanitaria Parc Tauli
Sabadell, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Lindenhofspital - Quartier Bleu
Bern, , Switzerland
Kinderspital Zuerich
Zurich, , Switzerland
Universitaetsspital Zuerich
Zurich, , Switzerland
Papworth Hospital NHS Foundation Trust, Papworth Everard
Cambridge, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
The Leeds Teaching Hospitals NHS Trust, St. James University Hospital
Leeds, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Center
Nottingham, , United Kingdom
University Hospital Llandough
Penarth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004132-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX17-659-102
Identifier Type: -
Identifier Source: org_study_id
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