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This study evaluated the efficacy and safety of the drug VX-661 combined with Ivacaftor compared with placebo in patients with cystic fibrosis. It included patients who were homozygous for the F508del CFTR mutation with a confirmed diagnosis. It was conducted in Phase 3 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.
Inclusion Criteria: * Homozygous for the F508del CFTR mutation, genotype to be confirmed at the Screening Visit * Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis * Forced expiratory volume at one second (FEV1) ≥40% and ≤90% of predicted normal for age, sex, and height during screening * Stable CF disease as judged by the investigator * Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit Exclusion Criteria: * History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. * An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug) * Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Day 1) * Sexually active participants of reproductive potential who are not willing to follow the contraception requirements