A long-term extension study of the combined effects of three CFTR modulator medicines in people with cystic fibrosis aged 6 and older (VX19 445 107)

Details

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

Full title

A Phase 3 extension study of the long-term efficacy and safety of a triple combination therapy of VX-445, tezacaftor and ivacaftor in people with cystic fibrosis aged 6 and older

VX-445 is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis. This study is an extension of existing study (VX18-445-106) to look at the long-term efficacy and 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.
Participants from the previous study who chose to take part in this extension will take VX-445, tezacaftor and ivacaftor in the morning (in 2 tablets), and ivacaftor in the evening (1 tablet).
The study will involve up to 11 clinic visits and 15 telephone consultations over 100 weeks (approximately 2 years). During clinic visits, bloods and other samples, lung function, questionnaires, and other investigations will be used to measure how the drug is working.

Trial Reference Number
129581
Trial type
Medication
Intervention
CFTR Modulators
Last edited date
21/01/2020
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Top inclusion criteria
  • 6 Years and older
  • Currently participating in study VX18-445-106
Top exclusion criteria
  • History of intolerance in study VX18-445-106
  • Current participation in an investigational drug trial (other than study VX18-445-106 )

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