A Phase 3 Open-Label Study of Elexacaftor/Tezacaftor/Ivacaftor in Children 6 through 11 Years of Age with Cystic Fibrosis and at Least One F508del Allele.

doi:10.1164/rccm.202102-0509OC

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A Phase 3 Open-Label Study of Elexacaftor/Tezacaftor/Ivacaftor in Children 6 through 11 Years of Age with Cystic Fibrosis and at Least One F508del Allele.

American journal of respiratory and critical care medicine - 15 Jun 2021

Zemanick Edith T, Taylor-Cousar Jennifer L, Davies Jane, Gibson Ronald L, Mall Marcus A, McKone Edward F, McNally Paul, Ramsey Bonnie W, Rayment Jonathan H, Rowe Steven M, Tullis Elizabeth, Ahluwalia Neil, Chu Chenghao, Ho Thang, Moskowitz Samuel M, Noel Sabrina, Tian Simon, Waltz David, Weinstock Tanya G, Xuan Fengjuan, Wainwright Claire E, McColley Susanna A

Abstract excerpt

Rationale: Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was shown to be efficacious and safe in patients ≥12 years of age with cystic fibrosis and at least one F508del-CFTR (cystic fibrosis transmembrane conductance regulator) allele, but it has not been evaluated in children <12 years of age. Objectives: To assess the safety, pharmacokinetics, and efficacy of ELX/TEZ/IVA in children 6 through 11 years of age...

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PMID: 33734030
DOI: 10.1164/rccm.202102-0509OC
PMCID: PMC8483230

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