A study of the combined long-term safety of three CFTR modulator medicines in people with cystic fibrosis (VX19 445 115)

Details

Therapeutic category
Restore CFTR Function
Trial status
Closed to recruitment - in follow up
Phase
Phase III

Full title

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

In 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
Trial Reference Number
133421
Trial type
Medication
Intervention
CFTR Modulators
Recruitment target
0
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 VX18-445-109
Top exclusion criteria
  • History of intolerance in study VX18-445-109
  • Current participation in an investigational drug trial (other than study VX18-445-109)

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