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 VX-659 Combination Therapy in CF Subjects Homozygous for F508del

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

Phase
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

Phase 3

Full title

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation

Trial Reference Number

108751

Trial type

Medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

24 weeks

Intervention
the name of the treatment or therapy being researched

ivacaftor/tezacaftor

Last edited date

17 May 2018

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Mutation

Two copies of F508del (delta F508)

Top inclusion criteria
  • 12 Years and older
  • FEV1 above or equal to 40% and below or equal to 90%
Top exclusion criteria
  • Clinically significant cirrhosis with or without portal hypertension.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Lung infection with organisms associated with a more rapid decline in pulmonary status.

CF centres running this trial

Closed

Central Manchester University Hospitals NHS Foundation Trust

Address

Trust Headquarters Cobbett House Manchester Royal Infirmary Oxford Road Manchester Greater Manchester M13 9WL

Recruitment ends

July 2018

Contact

,

Get in touch

Closed

Liverpool Heart and Chest Hospitals NHS Foundation Trust

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment ends

July 2018

Contact

,

Get in touch

Closed

Papworth Hospital NHS Foundation Trust

Address

Papworth Hall Papworth Everard Cambridge Cambridgeshire CB23 3RE

Recruitment ends

June 2018

Contact

,

Get in touch

Closed

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment ends

June 2018

Contact

,

Get in touch
Show all participating centres