Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001661
- Last updated
- 01/07/2019
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
Study detailsThis 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.
- Phase
- Phase 3
- Length of participation
- 96 weeks
- Recruitment target
- 15
- CF sponsor
- Vertex Pharmaceuticals Incorporated
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 6 years and older
- Including people
Homozygous for the F508del-CFTR mutation
Weight >= 15Kg
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