[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100270217":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":18,"locations":23,"responsibleParty":186,"collaborators":18,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":18,"eligibilityCriteria":194,"healthyVolunteers":195,"sex":196,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":18,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":210,"whyStopped":18,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumacaftor\u002FIvacaftor (LUM\u002FIVA)","EXPERIMENTAL","Part A (\\\u003C14 kg): Participants weighing less than (\\\u003C) 14 kilograms (kg) at screening received LUM 100 milligram (mg)\u002FIVA 125 mg fixed-dose combination every 12 hours for 15 days in Part A.\n\nPart A (\\>=14 kg): Participants weighing greater than or equal to (\\>=) 14 kg at screening received LUM 150 mg\u002FIVA 188 mg fixed-dose combination every 12 hours for 15 days in Part A.\n\nPart B (\\\u003C14 kg): Participants weighing \\\u003C14 kg at screening received LUM 100 mg\u002FIVA 125 mg fixed-dose combination every 12 hours for 24 weeks in Part B.\n\nPart B (\\>=14 kg): Participants weighing \\>=14 kg at screening received LUM 150 mg\u002FIVA 188 mg fixed-dose combination every 12 hours for 24 weeks in Part B.",[13],"Drug: LUM\u002FIVA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","LUM\u002FIVA",null,[9],[21,22],"Orkambi","VX-809+VX-770",[24,35,43,51,59,67,75,83,91,99,107,114,121,129,137,145,153,161,171,179],{"facility":18,"status":18,"city":25,"state":26,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":18},"Palo Alto","California","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-122.14302,37.44188,{"lat":33,"lon":32},{"facility":18,"status":18,"city":36,"state":37,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":38,"geoPoint":42,"contacts":18},"Aurora","Colorado",{"type":30,"coordinates":39},[40,41],-104.83192,39.72943,{"lat":41,"lon":40},{"facility":18,"status":18,"city":44,"state":45,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":46,"geoPoint":50,"contacts":18},"Chicago","Illinois",{"type":30,"coordinates":47},[48,49],-87.65005,41.85003,{"lat":49,"lon":48},{"facility":18,"status":18,"city":52,"state":53,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":54,"geoPoint":58,"contacts":18},"Indianapolis","Indiana",{"type":30,"coordinates":55},[56,57],-86.15804,39.76838,{"lat":57,"lon":56},{"facility":18,"status":18,"city":60,"state":61,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":62,"geoPoint":66,"contacts":18},"Boston","Massachusetts",{"type":30,"coordinates":63},[64,65],-71.05977,42.35843,{"lat":65,"lon":64},{"facility":18,"status":18,"city":68,"state":69,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":70,"geoPoint":74,"contacts":18},"Minneapolis","Minnesota",{"type":30,"coordinates":71},[72,73],-93.26384,44.97997,{"lat":73,"lon":72},{"facility":18,"status":18,"city":76,"state":77,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":78,"geoPoint":82,"contacts":18},"Kansas City","Missouri",{"type":30,"coordinates":79},[80,81],-94.57857,39.09973,{"lat":81,"lon":80},{"facility":18,"status":18,"city":84,"state":85,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":86,"geoPoint":90,"contacts":18},"Buffalo","New York",{"type":30,"coordinates":87},[88,89],-78.87837,42.88645,{"lat":89,"lon":88},{"facility":18,"status":18,"city":92,"state":93,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":94,"geoPoint":98,"contacts":18},"Chapel Hill","North Carolina",{"type":30,"coordinates":95},[96,97],-79.05584,35.9132,{"lat":97,"lon":96},{"facility":18,"status":18,"city":100,"state":101,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":102,"geoPoint":106,"contacts":18},"Cincinnati","Ohio",{"type":30,"coordinates":103},[104,105],-84.51439,39.12711,{"lat":105,"lon":104},{"facility":18,"status":18,"city":108,"state":101,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":109,"geoPoint":113,"contacts":18},"Cleveland",{"type":30,"coordinates":110},[111,112],-81.69541,41.4995,{"lat":112,"lon":111},{"facility":18,"status":18,"city":115,"state":101,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":116,"geoPoint":120,"contacts":18},"Columbus",{"type":30,"coordinates":117},[118,119],-82.99879,39.96118,{"lat":119,"lon":118},{"facility":18,"status":18,"city":122,"state":123,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":124,"geoPoint":128,"contacts":18},"Philadelphia","Pennsylvania",{"type":30,"coordinates":125},[126,127],-75.16362,39.95238,{"lat":127,"lon":126},{"facility":18,"status":18,"city":130,"state":131,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":132,"geoPoint":136,"contacts":18},"Charleston","South Carolina",{"type":30,"coordinates":133},[134,135],-79.93275,32.77632,{"lat":135,"lon":134},{"facility":18,"status":18,"city":138,"state":139,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":140,"geoPoint":144,"contacts":18},"Houston","Texas",{"type":30,"coordinates":141},[142,143],-95.36327,29.76328,{"lat":143,"lon":142},{"facility":18,"status":18,"city":146,"state":147,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":148,"geoPoint":152,"contacts":18},"Norfolk","Virginia",{"type":30,"coordinates":149},[150,151],-76.28522,36.84681,{"lat":151,"lon":150},{"facility":18,"status":18,"city":154,"state":155,"zip":18,"country":27,"countryCode":28,"cosmosGeoPoint":156,"geoPoint":160,"contacts":18},"Seattle","Washington",{"type":30,"coordinates":157},[158,159],-122.33207,47.60621,{"lat":159,"lon":158},{"facility":18,"status":18,"city":162,"state":163,"zip":18,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":18},"Vancouver","British Columbia","Canada","CA",{"type":30,"coordinates":167},[168,169],-123.11934,49.24966,{"lat":169,"lon":168},{"facility":18,"status":18,"city":172,"state":173,"zip":18,"country":164,"countryCode":165,"cosmosGeoPoint":174,"geoPoint":178,"contacts":18},"Toronto","Ontario",{"type":30,"coordinates":175},[176,177],-79.39864,43.70643,{"lat":177,"lon":176},{"facility":18,"status":18,"city":180,"state":18,"zip":18,"country":164,"countryCode":165,"cosmosGeoPoint":181,"geoPoint":185,"contacts":18},"Montreal",{"type":30,"coordinates":182},[183,184],-73.58781,45.50884,{"lat":184,"lon":183},{"type":187,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100270217","phase-3-safety-and-pharmacokinetic-study-of-lumacaftorivacaftor-in-subjects-aged-2-through-5-years-with-cystic-fibrosis-homozygous-for-f508del-100270217",true,"NCT02797132","Safety and Pharmacokinetic Study of Lumacaftor\u002FIvacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del","A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor\u002FIvacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation","Inclusion Criteria:\n\n* Subjects who weigh ≥8 kilogram (kg) without shoes and wearing light clothing at the Screening Visit\n* Subjects with confirmed diagnosis of CF at the Screening Visit\n* Subjects who are homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation\n\nExclusion Criteria:\n\n* Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject\n* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1\n* A standard 12-lead ECG demonstrating QTc \\>450 millisecond (msec) at the Screening Visit.\n* History of solid organ or hematological transplantation.\n* Ongoing or prior participation in an investigational drug study (including studies investigating LUM and\u002For IVA) within 30 days of the Screening Visit.\n* History of cataract\u002Flens opacity or evidence of cataract\u002Flens opacity determined to be clinically significant by a licensed ophthalmologist during the ophthalmologic examination at the Screening Visit",false,"ALL","2 Years","5 Years",{"count":200,"type":201},62,"ACTUAL","INTERVENTIONAL",[204],"PHASE3","This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor\u002Fivacaftor (LUM\u002FIVA) in subjects 2 through 5 years of age (inclusive) with cystic fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in Part B, if they meet the eligibility criteria.",[207],"Cystic Fibrosis",[209],"CF","COMPLETED","2018-09-30",{"date":213,"type":201},"2018-10-30",{"date":215,"type":201},"2016-05",{"date":217,"type":201},"2017-09",{"name":5,"class":6},20]