VX15-809-110 Cystic Fibrosis
Research type
Research Study
Full title
A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
IRAS ID
193318
Contact name
Alastair Reid
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2015-001644-11
Duration of Study in the UK
years, 24 months, days
Research summary
This is a Phase 3, Open-Label, Rollover study for participants who are aged 6 years and older with cystic fibrosis (CF) homozygous (having similar pairs of gene for any given pair of inherited characteristics) for the F508-CFTR mutation who took part in the VX14-809-109 study. This study will look at how safe and effective treatment over a long period of time is when lumacaftor and ivacaftor are used together. In this project all participants that meet all the rules of the extension study from the parent study (VX14-809-109) will be treated with lumacaftor and ivacaftor together for approximately 96 weeks with a follow up 28 days after the last dose. All participants will be expected to attend the clinic for 15 visits over the study duration and will undergo a range of tests.
There is also an observational group that will enable participants that received at least 4 weeks of the study drug in the parent study who meet the rules of this study to enrol. In this part of the study participants will receive regular phone calls.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
15/NE/0403
Date of REC Opinion
22 Jan 2016
REC opinion
Further Information Favourable Opinion