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About
This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Body weight ≥35 kg.
Subjects must have an eligibleCFTR genotype.
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
124 participants in 8 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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