Offered by: Nemours Children's
A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (16 weeks)
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).
Individuals, 12 years of age or older, who have a confirmed diagnosis of Cystic Fibrosis and have two F508 deletions (F/F).
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:
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