A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
NCT ID: NCT03525548
Last Updated: 2020-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
113 participants
INTERVENTIONAL
2018-08-03
2018-12-28
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
QUADRUPLE
Study Groups
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TEZ/IVA
Following a run-in period of 4 weeks with Tezacaftor (TEZ)/Ivacaftor (IVA), participants received TEZ 100 milligram (mg)/IVA 150 mg as fixed-dose combination (FDC) tablet in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the triple combination (TC) treatment period.
TEZ/IVA
Participants received TEZ/IVA orally once daily in the morning.
IVA
Participants received IVA orally once daily in the evening.
Placebo
Participants received placebo matched to VX-445/TEZ/IVA orally once daily in the morning.
VX-445/TEZ/IVA TC
Following a run-in period of 4 weeks with TEZ/IVA, participants received VX-445 200 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 4 weeks in the TC treatment period.
VX-445/TEZ/IVA
Participants received VX-445/TEZ/IVA orally once daily in the morning.
IVA
Participants received IVA orally once daily in the evening.
Placebo
Participants received placebo matched TEZ/IVA orally once daily in the morning.
Interventions
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VX-445/TEZ/IVA
Participants received VX-445/TEZ/IVA orally once daily in the morning.
TEZ/IVA
Participants received TEZ/IVA orally once daily in the morning.
IVA
Participants received IVA orally once daily in the evening.
Placebo
Participants received placebo matched to VX-445/TEZ/IVA orally once daily in the morning.
Placebo
Participants received placebo matched TEZ/IVA orally once daily in the morning.
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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Banner University of Arizona Medical Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Miller Children's Hospital/ Long Beach Memorial
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
National Jewish Health
Denver, Colorado, United States
Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital
Hollywood, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Tampa General Hospital Cardiac and Lung Transplant Clinic
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Saint Francis Medical Center/ Children's Hospital of Illinoise/OSF
Peoria, Illinois, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center
Boston, Massachusetts, United States
Harper University Hospital
Detroit, Michigan, United States
New York Medical College
Valhalla, New York, United States
UNC Marisco Clinical Research Center
Chapel Hill, North Carolina, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
ProMedica Toledo Hospital/ Toledo Children's Hospital/ Pediatric Pulmonary & Cystic Fibrosis Center
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Vermont Lung Center
Colchester, Vermont, United States
University of Virginia Primary Care Center
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Brussel - Campus Jette
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Academic Medical Center
Amsterdam, , Netherlands
University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis
Heidelberglaan, , Netherlands
UMC St. Radboud
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
HagaZiekenhuis van den Haag
The Hague, , Netherlands
The Royal Belfast Hospital for Sick Children
Belfast, , United Kingdom
Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
King's College Hospital
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Heijerman HGM, McKone EF, Downey DG, Van Braeckel E, Rowe SM, Tullis E, Mall MA, Welter JJ, Ramsey BW, McKee CM, Marigowda G, Moskowitz SM, Waltz D, Sosnay PR, Simard C, Ahluwalia N, Xuan F, Zhang Y, Taylor-Cousar JL, McCoy KS; VX17-445-103 Trial Group. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1940-1948. doi: 10.1016/S0140-6736(19)32597-8. Epub 2019 Oct 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000184-89
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX17-445-103
Identifier Type: -
Identifier Source: org_study_id
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