EU Clinical Trial 2019-002189-11

A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation  May 27, 2019

Main objective of the trial: To evaluate the treatment effect of VX-661 in combination with ivacaftor (VX-661/ivacaftor) on chest imaging endpoints as evaluated using low-dose computed tomography (LDCT) at Week 72 in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

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AU EU
Keywords
Kalydeco Symkevi VX-661/ivacaftor 100mg/150mg

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Source:  EMA Last updated:  May 30, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.