[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100295397":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":22,"locations":23,"responsibleParty":227,"collaborators":22,"id":229,"slug":230,"hasResults":231,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":22,"eligibilityCriteria":235,"healthyVolunteers":236,"sex":237,"minAge":238,"maxAge":22,"enrollmentInfo":239,"targetDuration":22,"studyType":242,"phases":243,"briefSummary":245,"conditions":246,"keywords":22,"overallStatus":248,"whyStopped":22,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LUM\u002FIVA","EXPERIMENTAL","LUM\u002FIVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg\u002FIVA 125 mg granules or LUM 150 mg\u002FIVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg\u002FIVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.",[13],"Drug: LUM\u002FIVA",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants received LUM\u002FIVA every q12h.",[9],[20,21],"VX-809\u002FVX-770","lumacaftor\u002Fivacaftor",null,[24,37,47,57,67,77,87,97,107,117,127,136,145,155,165,175,185,195,207,217],{"facility":25,"status":22,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":22},"Stanford University","Palo Alto","California","94305","United States","US",{"type":32,"coordinates":33},"Point",[34,35],-122.14302,37.44188,{"lat":35,"lon":34},{"facility":38,"status":22,"city":39,"state":40,"zip":41,"country":29,"countryCode":30,"cosmosGeoPoint":42,"geoPoint":46,"contacts":22},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":32,"coordinates":43},[44,45],-104.83192,39.72943,{"lat":45,"lon":44},{"facility":48,"status":22,"city":49,"state":50,"zip":51,"country":29,"countryCode":30,"cosmosGeoPoint":52,"geoPoint":56,"contacts":22},"Ann & Robert Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":32,"coordinates":53},[54,55],-87.65005,41.85003,{"lat":55,"lon":54},{"facility":58,"status":22,"city":59,"state":60,"zip":61,"country":29,"countryCode":30,"cosmosGeoPoint":62,"geoPoint":66,"contacts":22},"Riley Hospital for Children at Indiana University Health","Indianapolis","Indiana","46202",{"type":32,"coordinates":63},[64,65],-86.15804,39.76838,{"lat":65,"lon":64},{"facility":68,"status":22,"city":69,"state":70,"zip":71,"country":29,"countryCode":30,"cosmosGeoPoint":72,"geoPoint":76,"contacts":22},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":32,"coordinates":73},[74,75],-71.05977,42.35843,{"lat":75,"lon":74},{"facility":78,"status":22,"city":79,"state":80,"zip":81,"country":29,"countryCode":30,"cosmosGeoPoint":82,"geoPoint":86,"contacts":22},"Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minn","Minneapolis","Minnesota","55404",{"type":32,"coordinates":83},[84,85],-93.26384,44.97997,{"lat":85,"lon":84},{"facility":88,"status":22,"city":89,"state":90,"zip":91,"country":29,"countryCode":30,"cosmosGeoPoint":92,"geoPoint":96,"contacts":22},"Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":32,"coordinates":93},[94,95],-94.57857,39.09973,{"lat":95,"lon":94},{"facility":98,"status":22,"city":99,"state":100,"zip":101,"country":29,"countryCode":30,"cosmosGeoPoint":102,"geoPoint":106,"contacts":22},"The Lung & Cystic Fibrosis Center at Women's & Children's Hospital of Buffalo","Buffalo","New York","14222",{"type":32,"coordinates":103},[104,105],-78.87837,42.88645,{"lat":105,"lon":104},{"facility":108,"status":22,"city":109,"state":110,"zip":111,"country":29,"countryCode":30,"cosmosGeoPoint":112,"geoPoint":116,"contacts":22},"University of North Carolina Hospitals","Chapel Hill","North Carolina","27514",{"type":32,"coordinates":113},[114,115],-79.05584,35.9132,{"lat":115,"lon":114},{"facility":118,"status":22,"city":119,"state":120,"zip":121,"country":29,"countryCode":30,"cosmosGeoPoint":122,"geoPoint":126,"contacts":22},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":32,"coordinates":123},[124,125],-84.51439,39.12711,{"lat":125,"lon":124},{"facility":128,"status":22,"city":129,"state":120,"zip":130,"country":29,"countryCode":30,"cosmosGeoPoint":131,"geoPoint":135,"contacts":22},"University Hospitals Cleveland Medical Center\u002FRainbow Babies and Children's Hospital","Cleveland","44106",{"type":32,"coordinates":132},[133,134],-81.69541,41.4995,{"lat":134,"lon":133},{"facility":137,"status":22,"city":138,"state":120,"zip":139,"country":29,"countryCode":30,"cosmosGeoPoint":140,"geoPoint":144,"contacts":22},"Nationwide Children's Hospital","Columbus","43205",{"type":32,"coordinates":141},[142,143],-82.99879,39.96118,{"lat":143,"lon":142},{"facility":146,"status":22,"city":147,"state":148,"zip":149,"country":29,"countryCode":30,"cosmosGeoPoint":150,"geoPoint":154,"contacts":22},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":32,"coordinates":151},[152,153],-75.16362,39.95238,{"lat":153,"lon":152},{"facility":156,"status":22,"city":157,"state":158,"zip":159,"country":29,"countryCode":30,"cosmosGeoPoint":160,"geoPoint":164,"contacts":22},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":32,"coordinates":161},[162,163],-79.93275,32.77632,{"lat":163,"lon":162},{"facility":166,"status":22,"city":167,"state":168,"zip":169,"country":29,"countryCode":30,"cosmosGeoPoint":170,"geoPoint":174,"contacts":22},"Texas Children's Hospital","Houston","Texas","77030",{"type":32,"coordinates":171},[172,173],-95.36327,29.76328,{"lat":173,"lon":172},{"facility":176,"status":22,"city":177,"state":178,"zip":179,"country":29,"countryCode":30,"cosmosGeoPoint":180,"geoPoint":184,"contacts":22},"Children's Hospital of the King's Daughters","Norfolk","Virginia","23507",{"type":32,"coordinates":181},[182,183],-76.28522,36.84681,{"lat":183,"lon":182},{"facility":186,"status":22,"city":187,"state":188,"zip":189,"country":29,"countryCode":30,"cosmosGeoPoint":190,"geoPoint":194,"contacts":22},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":32,"coordinates":191},[192,193],-122.33207,47.60621,{"lat":193,"lon":192},{"facility":196,"status":22,"city":197,"state":198,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":22},"British Columbia's Children's Hospital","Vancouver","British Columbia","V6H 3N1","Canada","CA",{"type":32,"coordinates":203},[204,205],-123.11934,49.24966,{"lat":205,"lon":204},{"facility":208,"status":22,"city":209,"state":210,"zip":211,"country":200,"countryCode":201,"cosmosGeoPoint":212,"geoPoint":216,"contacts":22},"The Hospital for Sick Children","Toronto","Ontario","M5G 1X8",{"type":32,"coordinates":213},[214,215],-79.39864,43.70643,{"lat":215,"lon":214},{"facility":218,"status":22,"city":219,"state":220,"zip":221,"country":200,"countryCode":201,"cosmosGeoPoint":222,"geoPoint":226,"contacts":22},"McGill University Health Centre, Glen Site, Montreal Children's Hospital","Montreal","Quebec","H4A 3J1",{"type":32,"coordinates":223},[224,225],-73.58781,45.50884,{"lat":225,"lon":224},{"type":228,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100295397","phase-3-a-rollover-safety-study-of-lumacaftorivacaftor-in-subjects-aged-2-years-and-older-with-cystic-fibrosis-homozygous-for-the-f508del-cftr-mutation-100295397",true,"NCT03125395","A Rollover Safety Study of Lumacaftor\u002FIvacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation","A Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor\u002FIvacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation","Inclusion Criteria:\n\nSubjects entering the Treatment Cohort must meet the following criteria:\n\n* Completed 24 weeks of LUM\u002FIVA treatment and the Safety Follow-up Visit in Study VX15-809-115 Part B (Study 115B, NCT02797132)\n* Willing to remain on a stable CF medication regimen through the Safety Follow-up Visit\n\nSubjects entering the Observational Cohort must meet 1 of the following criteria:\n\n* Completed 24 weeks of LUM\u002FIVA treatment and the Safety Follow-up Visit in Study 115B, but do not want to enroll in the Treatment Cohort.\n* Received at least 4 weeks of LUM\u002FIVA treatment and completed visits up to Week 24 and the Safety Follow-up Visit, if required, of Study 115B but are not taking LUM\u002FIVA at the end of the Study 115B Treatment Period (i.e., Week 24) because of a drug interruption and either did not receive Vertex approval to enroll in the Treatment Cohort or do not want to enroll in the Treatment Cohort.\n* Permanently discontinued LUM\u002FIVA in Study 115B after receiving at least 4 weeks of treatment and remained in the study from the time of treatment discontinuation through the Week 24 Visit and Safety Follow-up Visit, if required.\n\nExclusion Criteria (Treatment Cohort Only):\n\n* Prematurely discontinued LUM\u002FIVA treatment in Study 115B.\n* History of any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering LUM\u002FIVA to the subject\n* History of drug intolerance or other serious reactions to LUM\u002FIVA in Study 115B that would pose an additional risk to the subject in the opinion of investigator, and which should be discussed with the Vertex medical monitor.\n* Subjects with a history of allergy or hypersensitivity to LUM\u002FIVA.\n* Liver function test (LFT) abnormality meeting criteria for LUM\u002FIVA treatment interruption at the completion of Study 115B, for which no convincing alternative etiology is identified.\n* QTc value at the completion of Study 115B that would pose an additional risk to the subject in the opinion of investigator, and which should be discussed with the Vertex medical monitor\n* History of poor compliance with LUM\u002FIVA and\u002For procedures in Study 115B as deemed by the investigator.\n* Participation in an investigational drug trial (including studies investigating LUM and\u002For IVA) other than Study 115B.",false,"ALL","2 Years",{"count":240,"type":241},57,"ACTUAL","INTERVENTIONAL",[244],"PHASE3","A Rollover Safety Study of Lumacaftor\u002FIvacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for F508del.",[247],"Cystic Fibrosis","COMPLETED","2020-07-15",{"date":251,"type":241},"2020-08-07",{"date":253,"type":241},"2017-05-12",{"date":255,"type":241},"2019-07-17",{"name":5,"class":6},20]