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 category
Restore CFTR Function
Trial status
Closed to recruitment - in follow up Participating Centres

Full title

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

In 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
Trial Reference Number
124763
Trial type
Medication
Intervention
CFTR Modulators
Last edited date
15/09/2020
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older
  • Currently participating in study VX17-659-105
Top exclusion criteria
  • History of intolerance in study VX17-659-105
  • Current participation in an investigational drug trial (other than study VX17-659-105)

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