[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100410390":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":10,"locations":10,"responsibleParty":25,"collaborators":10,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":10,"eligibilityCriteria":33,"healthyVolunteers":30,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":10,"studyType":40,"phases":10,"briefSummary":41,"conditions":42,"keywords":44,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":10},{"fullName":5,"class":6},"Carmel Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"F508del homozygous adult CF patients",null,"F508del homozygous adult CF patients who commenced treatment with LUM-IVA",[13],"Drug: Lumacaftor, Ivacaftor Drug Combination",[15],{"type":16,"name":17,"description":10,"armGroupLabels":18,"otherNames":19},"DRUG","Lumacaftor, Ivacaftor Drug Combination",[9],[20],"Orkambi",[22],{"name":23,"affiliation":5,"role":24},"Karin Yaacoby-Bianu, MD","PRINCIPAL_INVESTIGATOR",{"type":24,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Karin Yaakobi Bianu","Senior physician, Pediatric Pulmonology Unit and CF Center","100410390","real-life-evaluation-of-the-multi-organ-effects-of-lumacaftorivacaftor-on-f508del-homozygous-cystic-fibrosis-patients-100410390",false,"NCT04623879","Real Life Evaluation of the Multi-organ Effects of Lumacaftor\u002FIvacaftor on F508del Homozygous Cystic Fibrosis Patients.","Inclusion Criteria:\n\n* Subjects who meet all of the following inclusion criteria will be eligible for this study:\n\n  1. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, and other study procedures.\n  2. Subjects (males and females), will be aged 18 years or older\n  3. Confirmed diagnosis of CF\n  4. Homozygous for the F508del-CFTR mutation.\n  5. Willing to remain on a stable CF medication regimen through 12 months.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be eligible for this study:\n\n  1. 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 subject.\n\n     For example:\n\n     • History of cirrhosis with portal hypertension, and\u002For history of risk factors for Torsade de Pointes (e.g., familial long QT syndrome, hypokalemia, heart failure, left ventricular hypertrophy, bradycardia, myocardial infarction, cardiomyopathy, history of arrhythmia \\[ventricular and atrial fibrillation\\]), obesity, acute neurologic events.\n  2. Any of the following abnormal laboratory values at Screening:\n\n     * Abnormal liver function defined as any 2 or more of the following: ≥3 × upper limit of normal (ULN) aspartate aminotransferase (AST), ≥3 × ULN alanine aminotransferase (ALT), ≥3 × ULN gamma-glutamyl transpeptidase (GGT), ≥3 × ULN alkaline phosphatase (ALP), or ≥2 × ULN total bilirubin\n     * Abnormal liver function defined as any increase of ≥5 × ULN AST or ALT\n     * Abnormal renal function defined as glomerular filtration rate ≤50 mL\u002Fmin\u002F1.73 m2\n  3. 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).\n  4. History of solid organ or hematological transplantation.\n  5. History or evidence of cataract, lens opacity, Y-suture, or lamellar rings determined to be clinically significant by the ophthalmologist during the ophthalmologic examination during the Screening Period.\n  6. History of alcohol or drug abuse in the past year, including but not limited to cannabis, cocaine, and opiates, as deemed by the investigator.\n  7. Pregnant or nursing females: Females of childbearing potential must have a negative pregnancy test at Screening and Day 1.","ALL","18 Years","99 Years",{"count":38,"type":39},13,"ACTUAL","OBSERVATIONAL","Background: Lumacaftor\u002FIvacaftor (LUM-IVA), a CFTR corrector-potentiator combination, was found to improve lung function and reduce pulmonary exacerbations (PEx). However, cystic fibrosis (CF) is a multi-organ disease and therefore there is a need for more information on the systemic effects of CFTR modulators.\n\nAim: To evaluate pancreatic function, bone metabolism and respiratory changes through a year of LUM-IVA treatment.\n\nMethods: A prospective real world, one-year study on F508del homozygous adult CF patients who commenced treatment with LUM-IVA. Visits were scheduled on the first day of treatment and every 3 months evaluating: symptoms, Body Mass Index (BMI), spirometry, laboratory tests and Quality of life. At baseline and at 12 months, the patients underwent sweat test, oral glucose tolerance test (OGTT), chest CT and dual-energy X-ray absorptiometry (DEXA).",[43],"Cystic Fibrosis",[45,46,47,48],"CFTR modulators","Lumacaftor\u002F Ivacaftor","Bone metabolism","Pancreatic function","COMPLETED","2021-02-02",{"date":52,"type":39},"2021-02-03",{"date":54,"type":39},"2016-12-29",{"date":56,"type":39},"2020-02-26",{"name":5,"class":6}]