A study of the combined long-term safety of three CFTR modulator medicines in people with cystic fibrosis (VX19 445 115)
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT002096
- Last updated
- 15/09/2020
A Phase 3b study of the long-term safety of a triple combination therapy of VX-445 (elaxacaftor), tezacaftor and ivacaftor in people with cystic fibrosis
Study detailsIn order to take part in this study you will already be taking part in the VX18-445-109 study. 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 safety of taking VX-445 in combination with tezacaftor and ivacaftor for a long time. All three of the medicines are CFTR modulators which means that they help the faulty CFTR protein to function 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
- Phase
- Phase 3
- Recruitment target
- 0
- 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 VX18-445-109- Excluding people
History of intolerance in study VX18-445-109
Current participation in an investigational drug trial (other than study VX18-445-109)