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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
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Restore CFTR Function

Trial status

Closed

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
the name of the treatment or therapy being researched

CFTR Modulators

Last edited date

21 January 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 )