A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age (VX20-445-111 B).
The primary objective of the study is to evaluate the PK of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC); To evaluate the safety and tolerability of ELX/TEZ/IVA;
Study details
Study-ID: NCT04537793, 2020-002251-38
Study-ID: NCT04537793, 2020-002251-38
DZL Disease Area: CFBE
DZL Disease Area: CFBE
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL recruiting center, DZL on steering board
DZL Role: DZL recruiting center, DZL on steering board
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: BIH / Charité - Associated Partner, UGMLC
DZL Participating Sites: BIH / Charité - Associated Partner, UGMLC
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