A study of the combined effects of three CFTR modulator medicines in people with cystic fibrosis aged 12 and older (VX18-445-113)

Details

CTAP badge
Therapeutic approach
Restore CFTR Function
Trial status
Recruitment complete Participating Centres
Trials Tracker ID
TT002066
Last updated
15/09/2020

Full title

A Phase 3 study of the long-term safety of a triple combination therapy of VX-445, tezacaftor and ivacaftor in people with cystic fibrosis aged 12 and older

Study details

In order to take part in this study you will already be taking part in the VX17-659-105 study, taking VX-659 with tezacaftor and ivacaftor. For this new study, you will switch to taking VX-445 instead of VX-659. Both combinations work in the same way. 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 long-term 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. Everyone in the study will get the study medications


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

Who can take part?

Age range
12 years and older
Including people

12 Years and older
Currently participating in study VX17-659-105

Excluding people

History of intolerance in study VX17-659-105
Current participation in an investigational drug trial (other than study VX17-659-105)

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CF centres running this trial

Closed

Cambridge Royal Papworth Hospital (Adults)

CTAP centre
NHS Trust
Royal Papworth Hospital NHS Foundation Trust
Address
Papworth Road
CB2 0AY
Local site investigator
Charles Haworth
Trial Coordinators
Deepa George
Victoria Christenssen
Closed

Glasgow - Queen Elizabeth University Hospital

CTAP centre
NHS Trust
NHS Greater Glasgow & Clyde
Address
1345 Govan Road
G51 4TF
Local site investigator
Gordon MacGregor
Trial Coordinators
Annie Husband
Closed

Liverpool Heart and Chest Hospital

NHS Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Address
Thomas Drive
Liverpool
L14 3PE
Local site investigator
Martin Ledson
Closed

Nottingham

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Local site investigator
Helen Barr
Trial Coordinators
Fozia Naushahi
Gillian Black
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
Nicholas Simmonds
Trial Coordinators
Sophie Pinnell
Closed

St James's University Hospital - Leeds (Adults)

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
St James's University Hospital
Beckett Street
LS9 7TF
Local site investigator
Daniel Peckham
Trial Coordinators
Helen Chadwick