Offered by: Nemours Children's
Location: Orlando and Jacksonville, Fla.
A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (32 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 both a F508 deletion and a MF mutation (F/MF).
Who can participate?
Individuals, 12 years of age or older, who have a confirmed diagnosis of Cystic Fibrosis and have both: a F508 deletion and a MF mutation (F/MF).
What is involved?
Participation could last approximately 32 weeks. This includes a screening period that will last up to 4 weeks, a 24-week treatment period and a follow-up 4 weeks after the last dose of the Study Drug.
There will be up to nine (9) clinic visits and one (1) telephone call, including:
- Blood draws: The total amount of blood that will be taken during this study will be about 167.5mL (34 teaspoons). Total of nine (9) scheduled blood draws.
- ECGs: Total of nine (9) scheduled ECGs.
- Spirometry (PFT): Total of nine (9) scheduled PFTs.
- Sweat Chloride Tests: Total of six (6) Sweat Chloride Tests.
- Eye Exams: Up to three (3) eye exams.