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A study looking at the long term treatment of a CFTR modulator (VX-661) when taken with Ivacaftor

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
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 Reference Number

38799

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 (24 months)

Intervention
the name of the treatment or therapy being researched

CFTR Modulators

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

80

Last edited date

17 October 2019

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • Willing to remain on a stable CF regimen through the Safety Follow-up Visit
  • Age 12 years and older
  • Homozygous or Heterozygous for F508del mutation
Top exclusion criteria
  • Participation in an investigational drug trial other than the parent studies of VX14-661-110 or other eligible Vertex studies investigating VX-661 in combination with ivacaftor

CF centres running this trial

Closed

Belfast Health and Social Care Trust

Address

Belfast Health and Social Care Trust Trust Headquarters A Floor Belfast City Hospital Lisburn Road Belfast BT9 7AB

Recruitment starts

February 2016

Recruitment ends

June 2016

Contact

Downey, Damian

Get in touch

Closed

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

Closed

Leeds Teaching Hospitals NHS Trust

Address

St. James's University Hospital Beckett Street Leeds West Yorkshire LS9 7TF

Recruitment starts

February 2016

Recruitment ends

February 2017

Contact

Peckham, Daniel

Get in touch

Closed

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
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