Lumacaftor Plus Ivacaftor Combination

DRUG3 trials

Sponsors

Vertex Pharmaceuticals Incorporated

Conditions

Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Phase 3

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

CompletedNCT01807949

Vertex Pharmaceuticals IncorporatedCystic Fibrosis, Homozygous for the F508del CFTR Mutation

Start: 2013-04-30End: 2014-04-30Updated: 2016-09-27

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

CompletedNCT01807923

Vertex Pharmaceuticals IncorporatedCystic Fibrosis, Homozygous for the F508del CFTR Mutation

Start: 2013-05-31End: 2014-04-30Updated: 2015-08-31

A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

CompletedNCT01931839

Vertex Pharmaceuticals IncorporatedCystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Start: 2013-10-31End: 2016-04-30Updated: 2017-05-12

Related Papers

Development of the Cystic Fibrosis Questionnaire-Revised-8 Dimensions: Estimating Utilities From the Cystic Fibrosis Questionnaire-Revised.

2022-12-097 citations

Measuring recovery in health-related quality of life during and after pulmonary exacerbations in patients with cystic fibrosis.

2018-12-2322 citations

Lumacaftor/Ivacaftor reduces pulmonary exacerbations in patients irrespective of initial changes in FEV<sub>1</sub>.

2018-08-2334 citations

Assessment of safety and efficacy of long-term treatment with combination lumacaftor and ivacaftor therapy in patients with cystic fibrosis homozygous for the F508del-CFTR mutation (PROGRESS): a phase 3, extension study.

2016-12-21200 citations

Efficacy and safety of lumacaftor/ivacaftor combination therapy in patients with cystic fibrosis homozygous for Phe508del CFTR by pulmonary function subgroup: a pooled analysis.

2016-06-10109 citations

Lumacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del<i>CFTR</i>

New England Journal of Medicine2015-05-171603 citations