A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
NCT ID: NCT03559062
Last Updated: 2020-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
67 participants
INTERVENTIONAL
2018-05-17
2018-12-21
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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Placebo
Participants with genotype F/F received placebo matched to TEZ/IVA fixed dose combination (FDC) in the morning and placebo matched to IVA in the evening for 8 weeks.
Placebo
Placebo matched to TEZ/IVA FDC
Placebo
Placebo matched to IVA
TEZ/IVA
Participants with genotype F/F received TEZ/IVA FDC in the morning and IVA in the evening for 8 weeks. Participants with genotype F/RF received TEZ/IVA FDC and placebo matched to IVA in the morning and IVA in the evening for 8 weeks.
TEZ/IVA
Participants weighing \<40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.
IVA
Participants weighing \<40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.
Placebo
Placebo matched to IVA
Ivacaftor
Participants with genotype F/RF received placebo matched to TEZ/IVA FDC in the morning and IVA in morning and evening for 8 weeks.
IVA
Participants weighing \<40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.
Placebo
Placebo matched to TEZ/IVA FDC
Interventions
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TEZ/IVA
Participants weighing \<40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.
IVA
Participants weighing \<40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.
Placebo
Placebo matched to TEZ/IVA FDC
Placebo
Placebo matched to IVA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with ppFEV1 of ≥70 percentage points adjusted for age, sex, height.
* Participants with a screening LCI2.5 result ≥7.5.
* Participants who are able to swallow tablets.
Exclusion Criteria
* Colonization with organisms associated with a more rapid decline in pulmonary status.
* Solid organ or hematological transplantation.
6 Years
11 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Hunter Medical Research Institute (HMRI)
New Lambton Heights, , Australia
Princess Margaret Hospital for Children
Perth, , Australia
Lady Cilento Children's Hospital
South Brisbane, , Australia
The Children's Hospital at Westmead
Westmead, , Australia
Universitair Ziekenhuis Brussel - Campus Jette
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
University of Copenhagen Rigshospitalet
Copenhagen, , Denmark
Groupe Hospitalier Pellegrin - Hôpital des Enfants
Bordeaux, , France
Hôpital Necker - Enfants Malades
Paris, , France
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
Giessen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Our Lady's Children's Hospital
Dublin, , Ireland
University Hospital Limerick
Limerick, , Ireland
Klinika Mukowiscydozy, Oddział Chorób Płuc SZP ZOZ
Dziekanów Leśny, , Poland
Inselspital - Universitaetsspital Bern
Bern, , Switzerland
Kinderspital Zuerich
Zurich, , Switzerland
Royal Hospital for Sick Children
Edinburgh, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Nottingham University Hospital City Campus
Nottingham, , 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.
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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2016-004479-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX16-661-115
Identifier Type: -
Identifier Source: org_study_id
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