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This study evaluated the medicine VX-809, compared with placebo, in cystic fibrosis patients who carry the ∆F508-CFTR mutation in both alleles. It was open to patients with confirmed cystic fibrosis, lung function (FEV1) at least 40% of predicted, and a weight of 40 kg or more. Sponsored by Vertex Pharmaceuticals Incorporated, the study was conducted 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.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Confirmed diagnosis of CF with ∆F508-CFTR mutation in both alleles * Forced expiratory volume in 1 second (FEV1) greater than or equal to (\>=) 40 percent (%) of predicted normal for age, gender, and height * Weight \>=40 kilograms (kg) and body mass index greater than or equal to 18.5 kilogram per square meter (kg/m\^2) * Screening laboratory values, tests, and physical examination within acceptable ranges * Negative pregnancy test (for women of child-bearing potential) * Able and willing to follow contraceptive requirements * Willing to remain on a stable medication regimen for the duration of study participation Exclusion Criteria: * History of any illness, or any ongoing acute illness, that could impact the safety of the study participant or may confound results of study * Pulmonary exacerbation or changes in therapy for pulmonary disease within 14 days before receiving the first dose of study drug * Impaired hepatic or renal function * History of organ or hematological transplant