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VX15-809-110 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, Rollover Study to Evaluate the Safety and Efficacy of Longterm Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508delCFTR Mutation

This study will look at whether two drugs (called lumacaftor and ivacaftor) can help treat cystic fibrosis when taken together over a long period of time. It will also look at whether they are safe over this period. You can only take part in this study if you took part in a study called VX14-809-109, and if you meet certain criteria. These criteria will be checked by the study doctor and nurse at a screening visit. If you meet these criteria you will be treated with lumacaftor and ivacaftor together for approximately 96 weeks. A follow up visit will be held 28 days after the last dose of lumacaftor and ivacaftor. You will need to attend the clinic for 15 visits over the study duration and will undergo a range of tests. Participants who stopped taking the study drugs early in the VX14-809-109 study will be invited to take part in an observational study. They will not receive the study drug but will receive regular phone calls.

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, Lumacaftor

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

15

Last edited date

30 August 2017

Sponsor

Vertex Pharmaceuticals Incorporated

Sponsor type

Commercial

Who can take part?

Age

0 - 12

Top inclusion criteria
  • Completed study visits up to Week 24 of Study 109 or Week 26 of Study 011B and did not permanently discontinue treatment
  • Willing to remain on a stable CF medication through the Safety Follow-up Visit
Top exclusion criteria
  • History of any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject (e.g., cirrhosis with portal hypertension)
  • History of drug intolerance in the prior study that would pose an additional risk to the subject in the opinion of investigator

CF centres running this trial

Recruiting

Leeds Teaching Hospitals NHS Trust

Address

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

Recruitment starts

June 2016

Recruitment ends

March 2018

Contact

Lee, Timothy

Get in touch

Recruiting

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

April 2016

Recruitment ends

June 2018

Contact

Davies, Jane C

Get in touch