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

CTAP badge
Therapeutic approach
Restore CFTR Function
Trial status
Recruitment complete Participating Centres
Trials Tracker ID
TT002091
Last updated
21/01/2020

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

Study details

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.


Phase
Phase 3
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Age range
6 years and older
Including people

6 Years and older
Currently participating in study VX18-445-106

Excluding people

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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CF centres running this trial

Closed

Birmingham Children's Hospital

CTAP centre
NHS Trust
Birmingham Women's and Children's NHS Foundation Trust
Address
Steelhouse Lane
B4 6NH
Local site investigator
Maya Desai
Trial Coordinators
Aoife Neal
Closed

Royal Brompton Hospital (London)

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Local site investigator
Jane Davies
Trial Coordinators
Sophie Pinnell