A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
NCT ID: NCT04105972
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
176 participants
INTERVENTIONAL
2019-10-03
2020-07-24
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 TEZ/IVA run-in period of 4 weeks, participants received TEZ 100 milligrams (mg) once daily (qd)/IVA 150 mg every 12 hours (q12h) in the treatment period for 24 weeks.
TEZ/IVA
Fixed-dose combination (FDC) tablet for oral administration.
IVA
Mono tablet for oral administration.
ELX/TEZ/IVA
Following TEZ/IVA run-in period of 4 weeks, participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 24 weeks.
ELX/TEZ/IVA
FDC tablet for oral administration.
IVA
Mono tablet for oral administration.
Interventions
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ELX/TEZ/IVA
FDC tablet for oral administration.
TEZ/IVA
Fixed-dose combination (FDC) tablet for oral administration.
IVA
Mono tablet for oral administration.
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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The Prince Charles Hospital
Chermside, , 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
The Royal Children's Hospital
Parkville, VIC, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
Universitair Ziekenhuis Brussel - Campus Jette
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Charite Paediatric Pulmonology Department
Berlin, , Germany
Universitaetsklinkum Koeln, CF-Studienzentrum
Cologne, , Germany
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
Essen, , Germany
Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie
Essen, , Germany
Johann Wolfgang Goethe University
Frankfurt, , Germany
Mukeviszidose-Zentrum am Universitatsklinikum Jena, Klinik fuer Kinder- und Jugendmedizin
Jena, , Germany
Klinikum Innenstadt, University of Munich
München, , Germany
Pneumologisches Studienzentrum Muenchen-West
München, , Germany
Belfast City Hospital
Belfast, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
University Hospitals Bristol NHS Foundation Trust, Bristol Royal Hospital
Bristol, , United Kingdom
Papworth Hospital NHS Foundation Trust, Papworth Everard
Cambridge, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Clinical Research Facility, Queen Elizabeth University Hospital
Glasgow, , United Kingdom
St. James University Hospital
Leeds, , United Kingdom
Leeds General Infirmary
Leeds, West Yorkshire, , United Kingdom
Alder Hey Children's Alder Hey Children's NHS Foundation Trust
Liverpool, , United Kingdom
Great Ormond Street Hospital for Sick Children
London, , United Kingdom
London and St Bartholomew's Hospital
London, , United Kingdom
The University Hospital of South Manchester
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
Southampton General Hospital
Southampton, , 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.
Sutharsan S, McKone EF, Downey DG, Duckers J, MacGregor G, Tullis E, Van Braeckel E, Wainwright CE, Watson D, Ahluwalia N, Bruinsma BG, Harris C, Lam AP, Lou Y, Moskowitz SM, Tian S, Yuan J, Waltz D, Mall MA; VX18-445-109 study group. Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial. Lancet Respir Med. 2022 Mar;10(3):267-277. doi: 10.1016/S2213-2600(21)00454-9. Epub 2021 Dec 20.
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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2019-001735-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX18-445-109
Identifier Type: -
Identifier Source: org_study_id
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