Your donation will make a difference:
Cystic Fibrosis Trust

Please Log in

Log in

Not a registered user? Register with us

This trial will be 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

VX14-661-110 Cystic Fibrosis

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

Open

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 III

Full title

A Phase 3, Openlabel, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment with VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis , Homozygous or Heterozygous for the F508del CFTR Mutation

This is a Phase 3, OpenLabel, Rollover study to look at how safe and effective longterm treatment with VX-661 together with Ivacaftor is in paticipants aged 12 years and older with cystic fibrosis (CF) that have a F508de-lCFTR mutation. The study involves treating all participants who meet all the rules of the study from one of the parent studies (VX-661-106,108,109 or 111) with a combination of VX-661 and Ivacaftor for approximately 96 weeks with a follow-up 28 days after the last dose. Approximately 1375 participants are potentially eligible to be enrolled. There is also an observational cohort (group) that will enable participants under 18 years of age that received at least 4 weeks of the study drug in the parent study who meet the other rules of the study to enroll. These participants will not receive any study drug but they will have regularly scheduled telephone calls to assess post treatment safety of the combination of VX661/Ivacaftor.

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

96 weeks

Intervention
The name of the treatment or therapy being researched

Ivacaftor and VX-661

Recruitment target
The number of participants who need to be recruited for the trial in the UK

80

Last edited date

22 May 2017

Sponsor

Vertex Pharmaceuticals Incorporated

Sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • Completed study drug Treatment Period in a parent study.
  • Willing to remain on a stable CF regimen through the Safety Follow-up Visit.
Top exclusion criteria
  • Participation in an investigational drug trial other than the parent studies of NCT02565914 or other eligible Vertex studies investigating VX-661 in combination with ivacaftor.

CF centres running this trial

Recruiting

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

March 2016

Recruitment ends

July 2018

Contact

Nash, Edward

Get in touch

Recruiting

Liverpool Heart and Chest Hospitals NHS Foundation Trust

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

February 2016

Recruitment ends

January 2018

Contact

,

Get in touch

Recruiting

Royal Devon and Exeter NHS Foundation Trust

Address

Royal Devon and Exeter Hospital Barrack Road Exeter Devon EX2 5DW

Recruitment ends

March 2019

Contact

Withers, Nick

Get in touch

Recruiting

Sheffield Children's NHS Foundation Trust

Address

Western Bank Sheffield South Yorkshire S10 2TH

Recruitment starts

February 2016

Recruitment ends

March 2018

Contact

Kansra, Sonal

Get in touch
Show all participating centres