A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
NCT ID: NCT02392234
Last Updated: 2018-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
248 participants
INTERVENTIONAL
2015-03-31
2017-02-28
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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VX-661/Ivacaftor combination
VX-661/Ivacaftor
Fixed dose combination tablet, oral use
Ivacaftor
Tablet, oral use
Placebo matched to Ivacaftor
Tablet, oral use
Ivacaftor monotherapy
Ivacaftor
Tablet, oral use
Placebo matched to VX-661/ ivacaftor
Fixed dose combination tablet, oral use
Placebo
Placebo matched to VX-661/ ivacaftor
Fixed dose combination tablet, oral use
Placebo matched to Ivacaftor
Tablet, oral use
Interventions
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VX-661/Ivacaftor
Fixed dose combination tablet, oral use
Ivacaftor
Tablet, oral use
Placebo matched to VX-661/ ivacaftor
Fixed dose combination tablet, oral use
Placebo matched to Ivacaftor
Tablet, oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height during screening
* Sweat chloride value ≥60 millimole per liter (mmol/L) during screening OR as documented in the participant's medical record
* Stable CF disease as judged by the investigator
Exclusion Criteria
* An acute upper or lower respiratory infection, pulmonary exacerbation
* History of solid organ or hematological transplantation
* Ongoing or prior participation in an investigational drug study (including studies investigating VX-661, lumacaftor \[VX-809\], and/or ivacaftor) within 30 days of screening
* Pregnant and nursing females
* Sexually active participants 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
Phoenix, Arizona, United States
Tucson, Arizona, United States
Long Beach, California, United States
Oakland, California, United States
Palo Alto, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Syracuse, New York, United States
Valhalla, New York, United States
Chapel Hill, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Sioux Falls, South Dakota, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Adelaide, , Australia
Melbourne, , Australia
South Brisbane, , Australia
Westmead, , Australia
Ghent, , Belgium
Montreal, , Canada
Québec, , Canada
Toronto, , Canada
Vancouver, , Canada
Marseille, Bouches-du-Rhone, France
Montpellier, Herault, France
Rennes, Ille Et Vilaine, France
Lille, Nord, France
Paris, Paris, France
Bron, Rhone, France
Bordeaux, , France
Munich, Bavaria, Germany
München, Bavaria, Germany
Hanover, Lower Saxony, Germany
Essen, North Rhine-Westphalia, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Ancona, , Italy
Milan, , Italy
Orbassano, , Italy
Potenza, , Italy
Roma, , Italy
Verona, , Italy
Amsterdam, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Utrecht, , Netherlands
Bern, , Switzerland
Sankt Gallen, , Switzerland
Zurich, , Switzerland
Exeter, Devon, United Kingdom
London, Greater London, United Kingdom
Manchester, Greater Manchester, United Kingdom
Southampton, Hampshire, United Kingdom
Liverpool, Lancashire, United Kingdom
Glasgow, Strathclyde, United Kingdom
Leeds, West Yorkshire, 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.
Acaster S, Mukuria C, Rowen D, Brazier JE, Wainwright CE, Quon BS, Duckers J, Quittner AL, Lou Y, Sosnay PR, McGarry LJ. Development of the Cystic Fibrosis Questionnaire-Revised-8 Dimensions: Estimating Utilities From the Cystic Fibrosis Questionnaire-Revised. Value Health. 2023 Apr;26(4):567-578. doi: 10.1016/j.jval.2022.12.002. Epub 2022 Dec 9.
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.
Rowe SM, Daines C, Ringshausen FC, Kerem E, Wilson J, Tullis E, Nair N, Simard C, Han L, Ingenito EP, McKee C, Lekstrom-Himes J, Davies JC. Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis. N Engl J Med. 2017 Nov 23;377(21):2024-2035. doi: 10.1056/NEJMoa1709847. Epub 2017 Nov 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-004788-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX14-661-108
Identifier Type: -
Identifier Source: org_study_id
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