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LUM/IVA

DRUG8 trials

Sponsors

Vertex Pharmaceuticals Incorporated

Conditions

Cystic Fibrosis

Phase 2

Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation
CompletedNCT03061331
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2017-01-31End: 2017-10-04Updated: 2018-10-02
A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
CompletedNCT03625466
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2018-08-10End: 2021-10-07Updated: 2022-11-02

Phase 3

Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
CompletedNCT02544451
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2015-08-31End: 2020-04-30Updated: 2021-05-24
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
CompletedNCT02797132
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2016-05-31End: 2017-09-30Updated: 2018-10-30
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
CompletedNCT03125395
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2017-05-12End: 2019-07-17Updated: 2020-08-07
Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
CompletedNCT04235140
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2020-02-24End: 2023-08-22Updated: 2024-09-19

Phase 4

A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation
TerminatedNCT02823470
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2016-06-30End: 2017-08-31Updated: 2018-09-27
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
CompletedNCT02875366
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2016-09-30End: 2017-10-31Updated: 2019-06-17

Related Papers

Long-Term Impact of Lumacaftor/Ivacaftor Treatment on Cystic Fibrosis Disease Progression in Children 2–5 Years of Age Homozygous for <i>F508del-CFTR</i> : A Phase 2, Open-Label Clinical Trial
Annals of the American Thoracic Society2024-08-228 citations
Effects of Lumacaftor/Ivacaftor on Cystic Fibrosis Disease Progression in Children 2 through 5 Years of Age Homozygous for <i>F508del-CFTR</i>: A Phase 2 Placebo-controlled Clinical Trial.
2023-08-0115 citations
Long-term safety of lumacaftor-ivacaftor in children aged 2-5 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a multicentre, phase 3, open-label, extension study.
2021-05-0627 citations
Long-term safety and efficacy of lumacaftor-ivacaftor therapy in children aged 6-11 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a phase 3, open-label, extension study.
2021-01-2823 citations
VO<sub>2max</sub> as an exercise tolerance endpoint in people with cystic fibrosis: Lessons from a lumacaftor/ivacaftor trial.
2020-12-2417 citations
Lumacaftor/ivacaftor in people with cystic fibrosis with an A455E–CFTR mutation
Journal of Cystic Fibrosis2020-11-2617 citations
Safety, pharmacokinetics, and pharmacodynamics of lumacaftor and ivacaftor combination therapy in children aged 2-5 years with cystic fibrosis homozygous for F508del-CFTR: an open-label phase 3 study.
2019-01-2491 citations
S96 An open-label extension (ext) study of lumacaftor/ivacaftor (lum/iva) therapy in patients aged 6 to 11 years with cystic fibrosis (cf) homozygous for f508del-cftr
2017-11-15