A study looking at the long term treatment of a CFTR modulator (VX-661) when taken with Ivacaftor

Details

Therapeutic category
Restore CFTR Function
Trial status
closed Participating Centres
Phase
Phase III

Full title

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

This 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.
Trial Reference Number
38799
Trial type
Medication
Length of participation
96 weeks
Intervention
CFTR Modulators
Recruitment target
80
Last edited date
17/10/2019
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Top inclusion criteria
  • 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
Top exclusion criteria
  • 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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