Yükleniyor... / Loading...
This study looks at the combination of Lumacaftor and Ivacaftor in people with cystic fibrosis who are homozygous for the F508del mutation in the CFTR gene (carrying this mutation in both copies), with Ivacaftor alone and placebo used for comparison. It enrolled patients aged 12 and older with lung function in a defined range. The study was carried out 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.
+49
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 * Homozygous for the F508del CFTR mutation * Forced expiratory volume in 1 second (FEV1) greater than or equal to (\>=) 40 percent (%) and less than or equal to (=\<) 90% of predicted normal for age, sex, and height * Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit Exclusion Criteria: * An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug * History of solid organ or hematological transplantation * History of alcohol or drug abuse in the past year * Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening * Use of strong inhibitors, moderate inducers or strong inducers of Cytochrome P450 3A (CYP3A) within 14 days before Day 1 of dosing