VX14-661-110 Cystic Fibrosis
A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation
Vertex Pharmaceuticals Incorporated
Duration of Study in the UK
3 years, 1 months, days
This is a Phase 3, Open-Label, Rollover study to look at how safe and effective long-term treatment with VX-661 together with Ivacaftor is in paticipants aged 12 years and older with cystic fibrosis (CF) that have a F508del-CFTR mutation.
The study involves treating all participants who meet all the rules of the study from one of the parent studies (VX-661-106,108,109 or 111) with a combination of VX-661 and Ivacaftor for approximately 96 weeks with a follow-up 28 days after the last dose. Approximately 1375 participants are potentially eligible to be enrolled.
There is also an observational cohort (group) that will enable participants under 18 years of age that received at least 4 weeks of the study drug in the parent study who meet the other rules of the study to enroll. These participants will not receive any study drug but they will have regularly scheduled telephone calls to assess post treatment safety of the combination of VX661/Ivacaftor.
South West - Central Bristol Research Ethics Committee
Date of REC Opinion
23 Oct 2015
Further Information Favourable Opinion