A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
NCT ID: NCT04043806
Last Updated: 2023-07-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
458 participants
INTERVENTIONAL
2019-08-09
2022-12-14
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 received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.
Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
ELX/TEZ/IVA
Fixed-dose combination (FDC) tablet for oral administration.
IVA
Tablet for oral administration.
Interventions
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ELX/TEZ/IVA
Fixed-dose combination (FDC) tablet for oral administration.
IVA
Tablet for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Current participation in an investigational drug trial (other than study VX17-659-105)
12 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Arnold Palmer Hospital Pulmonary and Sleep Medicine
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 Institute
Glenview, Illinois, United States
Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants
Niles, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
The 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, New Hampshire, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Albany Medical College, Pulmonary and Critical Care Medicine
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
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Sanford Children's Speciality Clinic
Sioux Falls, South Dakota, United States
University of Tennessee Medical Center
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
Texas Children's Hospital
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 & Cystic Fibrosis Clinic
Spokane, Washington, United States
Royal Adelaide Hospital
Adelaide, , Australia
The Prince Charles Hospital
Chermside, , Australia
Alfred Hospital
Melbourne, VIC, , Australia
Institute for Respiratory Health
Nedlands, , Australia
Perth Children's Hospital
Nedlands, , Australia
John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital
New Lambton, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
Stollery Children's Hospital
Edmonton, , Canada
Queen Elizabeth II Health Sciences Center
Halifax, , Canada
St. Michael's Hospital
Toronto, , Canada
Juliane Marie Center, Rigshospitalet
Copenhagen, , Denmark
Charite Paediatric Pulmonology Department
Berlin, , Germany
Universitaetsklinkum Koeln, CF-Studienzentrum
Cologne, , Germany
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
Essen, , Germany
Johann Wolfgang Goethe University
Frankfurt, , Germany
Hannover Medical School
Hanover, , Germany
Universitaetsklinikum Jena, Mukoviszidose-Zentrum
Jena, , Germany
Universitatsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin
Lübeck, , Germany
Klinikum Innenstadt, University of Munich
München, , Germany
Pneumologisches Studienzentrum Muenchen-West
München, , Germany
Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
Children's Health Ireland at Crumlin
Dublin, , Ireland
Children's Health Ireland at Temple Street
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
University Hospital Limerick (Adults)
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
Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY
Łomianki, , 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
Parc Tauli Sabadell Hospital Universitari
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
Papworth Hospital NHS Foundation Trust, Papworth Everard
Cambridge, , United Kingdom
NHS Greater Glasgow and Clyde, Gartnavel General Hospital
Glasgow, , United Kingdom
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
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
Penarth, , United Kingdom
Countries
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References
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Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.
Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004652-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX18-445-113
Identifier Type: -
Identifier Source: org_study_id
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