A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
NCT ID: NCT02412111
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
156 participants
INTERVENTIONAL
2015-06-30
2017-09-30
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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Ivacaftor (Run-in Period)
Ivacaftor 150 milligram (mg) tablet orally every 12 hours for 4 weeks.
Ivacaftor
VX-661 + Ivacaftor (Active comparator period)
VX-661 100 mg and ivacaftor 150 mg fixed-dose combination tablet orally once daily in the morning and ivacaftor 150 mg tablet orally once daily in the evening for 8 weeks.
Ivacaftor
Tezacaftor/Ivacaftor
Ivacaftor monotherapy (Active comparator period)
Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.
Ivacaftor
Interventions
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Ivacaftor
Tezacaftor/Ivacaftor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
* Stable CF disease as judged by the investigator.
Exclusion Criteria
* Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
12 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Oakland, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Augusta, Georgia, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Manchester, New Hampshire, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Morgantown, West Virginia, United States
Chermside, , Australia
Clayton, , Australia
Melbourne, , Australia
South Brisbane, , Australia
Westmead, , Australia
Innsbruck, , Austria
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Calgary, , Canada
Toronto, , Canada
Vancouver, , Canada
Paris, , France
Dresden, , Germany
Erlangen, , Germany
Essen, , Germany
Frankfurt, , Germany
Giessen, , Germany
Heidelberg, , Germany
Jena, , Germany
München, , Germany
Cork, , Ireland
Dublin, , Ireland
Bari, , Italy
Milan, , Italy
Roma, , Italy
Belfast, , United Kingdom
Birmingham, , United Kingdom
Cardiff, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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McKone EF, DiMango EA, Sutharsan S, Barto TL, Campbell D, Ahluwalia N, Higgins M, Owen CA, Tullis E. A phase 3, randomized, double-blind, parallel-group study to evaluate tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for F508del-CFTR and a gating mutation. J Cyst Fibros. 2021 Mar;20(2):234-242. doi: 10.1016/j.jcf.2020.11.003. Epub 2020 Dec 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VX14-661-109
Identifier Type: -
Identifier Source: org_study_id
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