Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial

Autor: Aurora, Paul, Verhulst, Stijn, Watson, Danie, Lorenz, Michael, Roehmel, Jobst, Gleiber, Wolfgang, Naehrig, Susanne, Stehling, Florian, Sutharsan, Sivagurunathan, van Koningsbruggen-Rietschel, Silke, Fischer, Rainald, Downey, Damian, Haworth, Charles, Duckers, Jamie, Legg, Julian, Barry, Peter, Thursfield, Rebecca, Doe, Simon James, Hilliard, Tom, MacGregor, Gordon, Nash, Edward F, Withers, Nicholas John, Peckham, Daniel, Barr, Helen Louise, Lee, Timothy, Gray, Robert, Vermeulen, Francois, Van Braeckel, Eva, Vanderhelst, Eef, Robinson, Philip J, Wainwright, Claire E, Smith, Daniel J, Mulrennan, Siobhain A, Clements, Barry S, Wark, Peter, McKone, Edward F, Downey, Damian G, Tullis, Elizabeth, Ahluwalia, Neil, Bruinsma, Bote G, Harris, Christopher, Lam, Anna P, Lou, Yiyue, Moskowitz, Samuel M, Tian, Simon, Yuan, Jason, Waltz, David, Mall, Marcus A

Publikováno v: In The Lancet Respiratory Medicine March 2022 10(3):267-277

Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR : a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial

Autor: Sivagurunathan Sutharsan, Edward F McKone, Damian G Downey, Jamie Duckers, Gordon MacGregor, Elizabeth Tullis, Eva Van Braeckel, Claire E Wainwright, Danie Watson, Neil Ahluwalia, Bote G Bruinsma, Christopher Harris, Anna P Lam, Yiyue Lou, Samuel M Moskowitz, Simon Tian, Jason Yuan, David Waltz, Marcus A Mall, Paul Aurora, Stijn Verhulst, Michael Lorenz, Jobst Roehmel, Wolfgang Gleiber, Susanne Naehrig, Florian Stehling, Silke van Koningsbruggen-Rietschel, Rainald Fischer, Damian Downey, Charles Haworth, Julian Legg, Peter Barry, Rebecca Thursfield, Simon James Doe, Tom Hilliard, Edward F Nash, Nicholas John Withers, Daniel Peckham, Helen Louise Barr, Timothy Lee, Robert Gray, Francois Vermeulen, Eef Vanderhelst, Philip J Robinson, Daniel J Smith, Siobhain A Mulrennan, Barry S Clements, Peter Wark

Publikováno v: VX18-445-109 study group 2021, ' Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial ', The Lancet. Respiratory medicine . https://doi.org/10.1016/S2213-2600(21)00454-9

BackgroundElexacaftor plus tezacaftor plus ivacaftor is a triple-combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator regimen shown to be generally safe and efficacious in people with cystic fibrosis aged 12 years or older

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