A study of the combined effects of three CFTR modulator medicines in children with cystic fibrosis aged 6 to 11 (VX18-445-106)

Details

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

Full title

A Phase 3 study of the efficacy, safety and the body’s effects on a triple combination therapy of VX-445, tezacaftor and ivacaftor in children with cystic fibrosis aged 6 to 11

VX-445 is an investigational medicine being studied to see how well it works and how safe it is in children with cystic fibrosis aged 6 to 11 years, when taken in combination with tezacaftor and ivacaftor. All three medicines are CFTR modulators which means that they help the faulty CFTR protein found in cystic fibrosis 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
Trial Reference Number
126329
Trial type
Medication
Intervention
CFTR Modulators
Last edited date
13/11/2020
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Top inclusion criteria
  • 6 Years to 11 Years
  • Homozygous or heterozygous for F508del mutation
Top exclusion criteria
  • Lung infection

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