A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (16 weeks)
Clinical Trial
Offered by: Nemours听Children's
Location: Orlando
Trial Name
A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (16 weeks)
What is the trial about?
The purpose of the study is to learn more about the effectiveness and safety of VX-445 used in combination with TEZ (tezacaftor) and IVA (ivacaftor) in patients with cystic fibrosis who have two F508 deletions (F/F).
Who can participate?
Individuals, 12 years of age or older, who have a confirmed diagnosis of Cystic Fibrosis and have two F508 deletions (F/F).
What is involved?
Participation could last approximately 16 weeks. This includes a screening period that will last up to four weeks, four-week run-in period, four-week treatment period and a follow-up four weeks after the last dose of the study drug.
There will be up to seven clinic visits, including:
- Blood draws: The total amount of blood that will be taken during this study will be about 137mL (about 28 teaspoons). Total of six scheduled blood draws.
- ECGs: Total of six scheduled ECGs.
- Spirometry (PFT): Total of six scheduled PFTs.
- Sweat Chloride Tests: Total of five sweat chloride tests.
- Eye Exam: One eye exam.
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