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
Project in Setup
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
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. Everyone in the study will get the study medications.
If you meet the rules for being in the study, you will take VX-445, tezacaftor and ivacaftor in the morning (in 2 pills), and ivacaftor in the evening (1 pill).
You will be asked to come into clinic around 8 times over up to 52 weeks. During visits, we will measure how the drug is affecting health with bloods and other samples, vital signs and other investigations.
You will also receive 7 telephone consultations, each around half an hour, during this period. You do not have to come to clinics for these.
Trial Reference Number
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the name of the treatment or therapy being researched
Last edited date
10 June 2020
Vertex Pharmaceuticals Incorporated
CF sponsor type