A study looking at the long term treatment of a CFTR modulator (VX-661) when taken with Ivacaftor
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001591
- Last updated
- 17/10/2019
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
Study detailsThis is a Phase 3, OpenLabel, Rollover study to look at how safe and effective longterm
treatment with VX-661 together with Ivacaftor is in paticipants aged 12 years and older with cystic fibrosis (CF) that have a F508de-lCFTR 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.
- Phase
- Phase 3
- Length of participation
- 96 weeks
- Recruitment target
- 80
- CF sponsor
- Vertex Pharmaceuticals Incorporated
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 12 years and older
- Including people
Completed study drug Treatment Period in a parent study
Willing to remain on a stable CF regimen through the Safety Follow-up Visit
Age 12 years and older
Homozygous or Heterozygous for F508del mutation- Excluding people
Participation in an investigational drug trial other than the parent studies of NCT02565914 or other eligible Vertex studies investigating VX-661 in combination with ivacaftor
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