[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100380557":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":22,"locations":23,"responsibleParty":250,"collaborators":22,"id":252,"slug":253,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":22,"eligibilityCriteria":258,"healthyVolunteers":259,"sex":260,"minAge":261,"maxAge":22,"enrollmentInfo":262,"targetDuration":22,"studyType":265,"phases":266,"briefSummary":268,"conditions":269,"keywords":22,"overallStatus":271,"whyStopped":22,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":280},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LUM\u002FIVA","EXPERIMENTAL","Participants weighing 7 to less than (\\\u003C) 9 kilograms (kg) received LUM 75 milligrams (mg)\u002FIVA 94 mg fixed-dose combination (FDC) every 12 hours (q12h) and those weighing 9 to \\\u003C14 kg received LUM 100 mg\u002FIVA 125 mg q12h in the treatment period of 96 weeks. Participants weighing greater than or equal to (\\>=)14 kg received LUM 150 mg\u002FIVA 188 mg FDC q12h in the treatment period of 96 weeks.",[13],"Drug: LUM\u002FIVA",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","LUM\u002FIVA granules for oral administration",[9],[20,21],"lumacaftor\u002Fivacaftor","VX-809\u002FVX-770",null,[24,37,47,57,67,77,87,97,107,117,127,136,146,156,165,175,185,194,204,214,224,234,242],{"facility":25,"status":22,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":22},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States","US",{"type":32,"coordinates":33},"Point",[34,35],-86.80249,33.52066,{"lat":35,"lon":34},{"facility":38,"status":22,"city":39,"state":40,"zip":41,"country":29,"countryCode":30,"cosmosGeoPoint":42,"geoPoint":46,"contacts":22},"Arkansas Children's Hospital","Little Rock","Arkansas","72202",{"type":32,"coordinates":43},[44,45],-92.28959,34.74648,{"lat":45,"lon":44},{"facility":48,"status":22,"city":49,"state":50,"zip":51,"country":29,"countryCode":30,"cosmosGeoPoint":52,"geoPoint":56,"contacts":22},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":32,"coordinates":53},[54,55],-104.83192,39.72943,{"lat":55,"lon":54},{"facility":58,"status":22,"city":59,"state":60,"zip":61,"country":29,"countryCode":30,"cosmosGeoPoint":62,"geoPoint":66,"contacts":22},"Yale New Haven Hospital","New Haven","Connecticut","06510",{"type":32,"coordinates":63},[64,65],-72.92816,41.30815,{"lat":65,"lon":64},{"facility":68,"status":22,"city":69,"state":70,"zip":71,"country":29,"countryCode":30,"cosmosGeoPoint":72,"geoPoint":76,"contacts":22},"Children's Healthcare of Atlanta","Atlanta","Georgia","30329",{"type":32,"coordinates":73},[74,75],-84.38798,33.749,{"lat":75,"lon":74},{"facility":78,"status":22,"city":79,"state":80,"zip":81,"country":29,"countryCode":30,"cosmosGeoPoint":82,"geoPoint":86,"contacts":22},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":32,"coordinates":83},[84,85],-87.65005,41.85003,{"lat":85,"lon":84},{"facility":88,"status":22,"city":89,"state":90,"zip":91,"country":29,"countryCode":30,"cosmosGeoPoint":92,"geoPoint":96,"contacts":22},"Riley Hospital for Children at Indiana University Health","Indianapolis","Indiana","46202",{"type":32,"coordinates":93},[94,95],-86.15804,39.76838,{"lat":95,"lon":94},{"facility":98,"status":22,"city":99,"state":100,"zip":101,"country":29,"countryCode":30,"cosmosGeoPoint":102,"geoPoint":106,"contacts":22},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":32,"coordinates":103},[104,105],-71.05977,42.35843,{"lat":105,"lon":104},{"facility":108,"status":22,"city":109,"state":110,"zip":111,"country":29,"countryCode":30,"cosmosGeoPoint":112,"geoPoint":116,"contacts":22},"Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"type":32,"coordinates":113},[114,115],-93.26384,44.97997,{"lat":115,"lon":114},{"facility":118,"status":22,"city":119,"state":120,"zip":121,"country":29,"countryCode":30,"cosmosGeoPoint":122,"geoPoint":126,"contacts":22},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":32,"coordinates":123},[124,125],-94.57857,39.09973,{"lat":125,"lon":124},{"facility":128,"status":22,"city":129,"state":120,"zip":130,"country":29,"countryCode":30,"cosmosGeoPoint":131,"geoPoint":135,"contacts":22},"Cardinal Glennon Children's Hospital - St. Louis University","St Louis","63104",{"type":32,"coordinates":132},[133,134],-90.19789,38.62727,{"lat":134,"lon":133},{"facility":137,"status":22,"city":138,"state":139,"zip":140,"country":29,"countryCode":30,"cosmosGeoPoint":141,"geoPoint":145,"contacts":22},"University of Rochester Medical Center","Rochester","New York","14642",{"type":32,"coordinates":142},[143,144],-77.61556,43.15478,{"lat":144,"lon":143},{"facility":147,"status":22,"city":148,"state":149,"zip":150,"country":29,"countryCode":30,"cosmosGeoPoint":151,"geoPoint":155,"contacts":22},"NC TraCS Institute - CTRC University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":32,"coordinates":152},[153,154],-79.05584,35.9132,{"lat":154,"lon":153},{"facility":157,"status":22,"city":158,"state":149,"zip":159,"country":29,"countryCode":30,"cosmosGeoPoint":160,"geoPoint":164,"contacts":22},"Wake Forest University Baptist Medical Center","Winston-Salem","27157",{"type":32,"coordinates":161},[162,163],-80.24422,36.09986,{"lat":163,"lon":162},{"facility":166,"status":22,"city":167,"state":168,"zip":169,"country":29,"countryCode":30,"cosmosGeoPoint":170,"geoPoint":174,"contacts":22},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":32,"coordinates":171},[172,173],-84.51439,39.12711,{"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 Medical Center of Dallas","Dallas","Texas","75235",{"type":32,"coordinates":181},[182,183],-96.80667,32.78306,{"lat":183,"lon":182},{"facility":186,"status":22,"city":187,"state":178,"zip":188,"country":29,"countryCode":30,"cosmosGeoPoint":189,"geoPoint":193,"contacts":22},"Cook Children's Medical Center","Fort Worth","76104",{"type":32,"coordinates":190},[191,192],-97.32085,32.72541,{"lat":192,"lon":191},{"facility":195,"status":22,"city":196,"state":197,"zip":198,"country":29,"countryCode":30,"cosmosGeoPoint":199,"geoPoint":203,"contacts":22},"University of Utah \u002F Primary Children's Medical Center","Salt Lake City","Utah","84132",{"type":32,"coordinates":200},[201,202],-111.89105,40.76078,{"lat":202,"lon":201},{"facility":205,"status":22,"city":206,"state":207,"zip":208,"country":29,"countryCode":30,"cosmosGeoPoint":209,"geoPoint":213,"contacts":22},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":32,"coordinates":210},[211,212],-122.33207,47.60621,{"lat":212,"lon":211},{"facility":215,"status":22,"city":216,"state":217,"zip":218,"country":29,"countryCode":30,"cosmosGeoPoint":219,"geoPoint":223,"contacts":22},"University of Wisconsin Hospital and Clinics","Madison","Wisconsin","53792",{"type":32,"coordinates":220},[221,222],-89.40123,43.07305,{"lat":222,"lon":221},{"facility":225,"status":22,"city":226,"state":22,"zip":22,"country":227,"countryCode":228,"cosmosGeoPoint":229,"geoPoint":233,"contacts":22},"McGill University Health Centre, Glen Site, Montreal Children's Hospital","Montreal","Canada","CA",{"type":32,"coordinates":230},[231,232],-73.58781,45.50884,{"lat":232,"lon":231},{"facility":235,"status":22,"city":236,"state":22,"zip":22,"country":227,"countryCode":228,"cosmosGeoPoint":237,"geoPoint":241,"contacts":22},"The Hospital for Sick Children","Toronto",{"type":32,"coordinates":238},[239,240],-79.39864,43.70643,{"lat":240,"lon":239},{"facility":243,"status":22,"city":244,"state":22,"zip":22,"country":227,"countryCode":228,"cosmosGeoPoint":245,"geoPoint":249,"contacts":22},"British Columbia's Children's Hospital","Vancouver",{"type":32,"coordinates":246},[247,248],-123.11934,49.24966,{"lat":248,"lon":247},{"type":251,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100380557","phase-3-long-term-safety-of-lumacaftorivacaftor-in-participants-with-cystic-fibrosis-who-are-homozygous-for-f508del-and-12-to-24-months-of-age-at-treatment-initiation-100380557",true,"NCT04235140","Long-term Safety of Lumacaftor\u002FIvacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to \u003C24 Months of Age at Treatment Initiation","A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor\u002FIvacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to \u003C24 Months of Age at Treatment Initiation","Key Inclusion Criteria:\n\n* Participants From Study VX16-809-122 Part B (Study 122)\n\n  * Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study 122B\n* Participants Not From Study 122\n\n  * Subjects will be 1 to less than 2 years of age\n  * Homozygous for the F508del mutation (F\u002FF)\n\nKey Exclusion Criteria:\n\n* Any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject\n* Solid organ or hematological transplantation\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","12 Months",{"count":263,"type":264},52,"ACTUAL","INTERVENTIONAL",[267],"PHASE3","This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to \\\u003C24 months of age at initiation of Lumacaftor\u002FIvacaftor (LUM\u002FIVA) treatment.",[270],"Cystic Fibrosis","COMPLETED","2024-08-20",{"date":274,"type":264},"2024-09-19",{"date":276,"type":264},"2020-02-24",{"date":278,"type":264},"2023-08-22",{"name":5,"class":6},23]