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This study examined the safety and efficacy of the drug VX-659 in combination with other drugs (such as TEZ/IVA) in people with cystic fibrosis. It enrolled participants who had an eligible CFTR gene genotype (carrying F508del) and lung function within a certain range. It was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key Inclusion Criteria: * Body weight ≥35 kg. * Subjects must have an eligibleCFTR genotype. * Part 1 and Part 3: Heterozygous for F508del and an MF mutation (F/MF) * Part 2: Homozygous for F508del (F/F) * FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height Key Exclusion Criteria: * History of clinically significant cirrhosis with or without portal hypertension. * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Lung infection with organisms associated with a more rapid decline in pulmonary status. * History of solid organ or hematological transplantation. Other protocol defined Inclusion/Exclusion criteria may apply.