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This study evaluated the medicine Ivacaftor, compared with placebo, in cystic fibrosis patients aged 12 and older who carry the G551D mutation in at least one allele. It was open to patients with confirmed cystic fibrosis and lung function (FEV1) between 40% and 90% of predicted. Sponsored by Vertex Pharmaceuticals Incorporated, the study 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: * Confirmed diagnosis of cystic fibrosis (CF) and G551D mutation in at least 1 allele * Forced expiratory volume in 1 second (FEV1) of 40% to 90% (inclusive) of predicted normal for age, gender, and height at Screening. * No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator * Willing to use highly effective birth control methods during the study Exclusion Criteria: * History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject * Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1 of the study * History of alcohol, medication or illicit drug abuse within one year prior to Day 1 * Abnormal liver function ≥ 3x the upper limit of normal * Abnormal renal function at Screening * History of solid organ or hematological transplantation * Pregnant, planning a pregnancy, breast-feeding, or unwilling to follow contraception requirements * Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening * Use of inhaled hypertonic saline treatment * Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4)