Your donation will make a difference:
Cystic Fibrosis Trust
Forum

Please Log in

Log in

Not a registered user? Register with us

This trial has been added to your watchlist.

Do you want to receive email notifications when the trial status changes?

No Yes

Unfollowing a trial will remove it from the watchlist and stop status change email notifications

Are you sure you want to unfollow this trial?

Yes, remove from watchlist

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

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

Participating Centres
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

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. If you meet the criteria for being in the study, you will take VX-445, tezacaftor and ivacaftor in the morning (in 2 tablets), and ivacaftor in the evening (1 tablet). You will be asked to come into clinic around 12 times over the 22-month (nearly 2 years) participation period. During visits, the effect of the treatment will be measured with sample collection, lung function, ECG and other medical checks. You will also receive 14 telephone calls during the participation period, each lasting around half an hour. You do not have to come to clinics for these calls. This study is expected to recruit 400 participants worldwide.

Trial Reference Number

124763

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

CFTR Modulators

Last edited date

20 December 2019

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older
  • Currently participating in study VX17-659-105
Top exclusion criteria
  • History of intolerance in study VX17-659-105
  • Current participation in an investigational drug trial (other than study VX17-659-105)

CF centres running this trial

Closed

Liverpool Heart and Chest Hospital

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

December 2019

Recruitment ends

September 2020

Contact

Ledson, Martin

Get in touch

Closed

Queen Elizabeth University Hospital

Address

1345 Govan Road G51 4TF

Recruitment starts

November 2019

Contact

MacGregor, Gordon

Get in touch

Closed

Royal Brompton Hospital

Address

Sydney Street London SW3 6NP

Recruitment starts

December 2019

Recruitment ends

January 2020

Contact

Simmonds, Nicholas

Get in touch

Closed

ST JAMES'S UNIVERSITY HOSPITAL

Address

BECKETT STREET, LEEDS, WEST YORKSHIRE LS9 7TF

Recruitment starts

November 2019

Recruitment ends

July 2020

Contact

Peckham, Daniel

Get in touch