A study of the combined effects of three CFTR modulator medicines in people with cystic fibrosis aged 12 and older (VX18-445-113)
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Recruitment complete Participating Centres
- Trials Tracker ID
- TT002066
- Last updated
- 15/09/2020
A Phase 3 study of the long-term safety of a triple combination therapy of VX-445, tezacaftor and ivacaftor in people with cystic fibrosis aged 12 and older
Study detailsIn order to take part in this study you will already be taking part in the VX17-659-105 study, taking VX-659 with tezacaftor and ivacaftor. For this new study, you will switch to taking VX-445 instead of VX-659. Both combinations work in the same way. VX-445 is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis. Your participation in this study will help us learn more about the long-term safety of VX-445 in combination with tezacaftor and ivacaftor. All three are CFTR modulators which means that they help the faulty CFTR protein to work properly. Tezacaftor is already approved for use and is what is known as a ‘corrector’. Ivacaftor is also already approved for use and is what is known as a ‘potentiator’. VX-445 is a corrector. Everyone in the study will get the study medications
- Phase
- Phase 3
- CF sponsor
- Vertex Pharmaceuticals Incorporated
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 12 years and older
- Including people
12 Years and older
Currently participating in study VX17-659-105- Excluding people
History of intolerance in study VX17-659-105
Current participation in an investigational drug trial (other than study VX17-659-105)