[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331928":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":35,"locations":36,"responsibleParty":303,"collaborators":35,"id":305,"slug":306,"hasResults":307,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":35,"eligibilityCriteria":311,"healthyVolunteers":312,"sex":313,"minAge":314,"maxAge":315,"enrollmentInfo":316,"targetDuration":35,"studyType":319,"phases":320,"briefSummary":322,"conditions":323,"keywords":35,"overallStatus":325,"whyStopped":35,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: LUM\u002FIVA","EXPERIMENTAL","Participants weighing 7 to less than (\\\u003C)10 kilograms (kg) at screening received LUM 75 milligrams (mg)\u002FIVA 94 mg fixed-dose combination (FDC) every 12 hours (q12h) and those weighing 10 to \\\u003C14 kg at screening received LUM 100 mg\u002FIVA 125 mg q12h for 15 days. Participants weighing greater than or equal to (\\>=)14 kg at screening received LUM 150 mg\u002FIVA 188 mg FDC q12h for 15 days.",[13,14],"Drug: LUM","Drug: IVA",{"label":16,"type":10,"description":17,"interventionNames":18},"Part B: LUM\u002FIVA","Participants weighing 7 to \\\u003C9 kg at screening received LUM 75 mg\u002FIVA 94 mg FDC q12h and those weighing 9 to \\\u003C14 kg received LUM 100 mg\u002FIVA 125 mg q12h for 24 weeks. Participants weighing \\>=14 kg at screening received LUM 150 mg\u002FIVA 188 mg FDC q12h for 24 weeks. Doses were adjusted upwards for changes in weight.",[13,14],[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","LUM","Fixed Dose Combination (FDC) granules (LUM\u002FIVA).",[9,16],[26,27],"lumacaftor","VX-809",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"IVA","FDC granules (LUM\u002FIVA).",[9,16],[33,34],"ivacaftor","VX-770",null,[37,50,60,70,80,90,100,110,120,130,140,150,160,170,179,189,199,208,218,228,238,247,257,267,277,287,295],{"facility":38,"status":35,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":35},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-86.80249,33.52066,{"lat":48,"lon":47},{"facility":51,"status":35,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":35},"Arkansas Children's Hospital","Little Rock","Arkansas","72202",{"type":45,"coordinates":56},[57,58],-92.28959,34.74648,{"lat":58,"lon":57},{"facility":61,"status":35,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":35},"Stanford University","Palo Alto","California","94304",{"type":45,"coordinates":66},[67,68],-122.14302,37.44188,{"lat":68,"lon":67},{"facility":71,"status":35,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":35},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":45,"coordinates":76},[77,78],-104.83192,39.72943,{"lat":78,"lon":77},{"facility":81,"status":35,"city":82,"state":83,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":35},"Yale New Haven Medical Center","New Haven","Connecticut","06511",{"type":45,"coordinates":86},[87,88],-72.92816,41.30815,{"lat":88,"lon":87},{"facility":91,"status":35,"city":92,"state":93,"zip":94,"country":42,"countryCode":43,"cosmosGeoPoint":95,"geoPoint":99,"contacts":35},"Nemours \u002F Alfred I. duPont Hospital for Children","Wilmington","Delaware","19803",{"type":45,"coordinates":96},[97,98],-75.54659,39.74595,{"lat":98,"lon":97},{"facility":101,"status":35,"city":102,"state":103,"zip":104,"country":42,"countryCode":43,"cosmosGeoPoint":105,"geoPoint":109,"contacts":35},"Children's Healthcare of Atlanta","Atlanta","Georgia","30329",{"type":45,"coordinates":106},[107,108],-84.38798,33.749,{"lat":108,"lon":107},{"facility":111,"status":35,"city":112,"state":113,"zip":114,"country":42,"countryCode":43,"cosmosGeoPoint":115,"geoPoint":119,"contacts":35},"Ann & Robert Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":45,"coordinates":116},[117,118],-87.65005,41.85003,{"lat":118,"lon":117},{"facility":121,"status":35,"city":122,"state":123,"zip":124,"country":42,"countryCode":43,"cosmosGeoPoint":125,"geoPoint":129,"contacts":35},"Riley Hospital for Children at Indiana University Health","Indianapolis","Indiana","46202",{"type":45,"coordinates":126},[127,128],-86.15804,39.76838,{"lat":128,"lon":127},{"facility":131,"status":35,"city":132,"state":133,"zip":134,"country":42,"countryCode":43,"cosmosGeoPoint":135,"geoPoint":139,"contacts":35},"Johns Hopkins Hospital","Baltimore","Maryland","21287",{"type":45,"coordinates":136},[137,138],-76.61219,39.29038,{"lat":138,"lon":137},{"facility":141,"status":35,"city":142,"state":143,"zip":144,"country":42,"countryCode":43,"cosmosGeoPoint":145,"geoPoint":149,"contacts":35},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":45,"coordinates":146},[147,148],-71.05977,42.35843,{"lat":148,"lon":147},{"facility":151,"status":35,"city":152,"state":153,"zip":154,"country":42,"countryCode":43,"cosmosGeoPoint":155,"geoPoint":159,"contacts":35},"Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"type":45,"coordinates":156},[157,158],-93.26384,44.97997,{"lat":158,"lon":157},{"facility":161,"status":35,"city":162,"state":163,"zip":164,"country":42,"countryCode":43,"cosmosGeoPoint":165,"geoPoint":169,"contacts":35},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":45,"coordinates":166},[167,168],-94.57857,39.09973,{"lat":168,"lon":167},{"facility":171,"status":35,"city":172,"state":163,"zip":173,"country":42,"countryCode":43,"cosmosGeoPoint":174,"geoPoint":178,"contacts":35},"Cardinal Glennon Children's Hospital - St. Louis University","St Louis","63104",{"type":45,"coordinates":175},[176,177],-90.19789,38.62727,{"lat":177,"lon":176},{"facility":180,"status":35,"city":181,"state":182,"zip":183,"country":42,"countryCode":43,"cosmosGeoPoint":184,"geoPoint":188,"contacts":35},"University of Rochester Medical Center","Rochester","New York","14642",{"type":45,"coordinates":185},[186,187],-77.61556,43.15478,{"lat":187,"lon":186},{"facility":190,"status":35,"city":191,"state":192,"zip":193,"country":42,"countryCode":43,"cosmosGeoPoint":194,"geoPoint":198,"contacts":35},"University of North Carolina Hospitals","Chapel Hill","North Carolina","27514",{"type":45,"coordinates":195},[196,197],-79.05584,35.9132,{"lat":197,"lon":196},{"facility":200,"status":35,"city":201,"state":192,"zip":202,"country":42,"countryCode":43,"cosmosGeoPoint":203,"geoPoint":207,"contacts":35},"Wake Forest University School of Medicine - Brenner Children's Hospital","Winston-Salem","27157",{"type":45,"coordinates":204},[205,206],-80.24422,36.09986,{"lat":206,"lon":205},{"facility":209,"status":35,"city":210,"state":211,"zip":212,"country":42,"countryCode":43,"cosmosGeoPoint":213,"geoPoint":217,"contacts":35},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":45,"coordinates":214},[215,216],-84.51439,39.12711,{"lat":216,"lon":215},{"facility":219,"status":35,"city":220,"state":221,"zip":222,"country":42,"countryCode":43,"cosmosGeoPoint":223,"geoPoint":227,"contacts":35},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":45,"coordinates":224},[225,226],-75.16362,39.95238,{"lat":226,"lon":225},{"facility":229,"status":35,"city":230,"state":231,"zip":232,"country":42,"countryCode":43,"cosmosGeoPoint":233,"geoPoint":237,"contacts":35},"Children's Medical Center of Dallas","Dallas","Texas","75235",{"type":45,"coordinates":234},[235,236],-96.80667,32.78306,{"lat":236,"lon":235},{"facility":239,"status":35,"city":240,"state":231,"zip":241,"country":42,"countryCode":43,"cosmosGeoPoint":242,"geoPoint":246,"contacts":35},"Cook Children's Medical Center","Fort Worth","76104",{"type":45,"coordinates":243},[244,245],-97.32085,32.72541,{"lat":245,"lon":244},{"facility":248,"status":35,"city":249,"state":250,"zip":251,"country":42,"countryCode":43,"cosmosGeoPoint":252,"geoPoint":256,"contacts":35},"University of Utah \u002F Primary Children's Medical Center","Salt Lake City","Utah","84132",{"type":45,"coordinates":253},[254,255],-111.89105,40.76078,{"lat":255,"lon":254},{"facility":258,"status":35,"city":259,"state":260,"zip":261,"country":42,"countryCode":43,"cosmosGeoPoint":262,"geoPoint":266,"contacts":35},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":45,"coordinates":263},[264,265],-122.33207,47.60621,{"lat":265,"lon":264},{"facility":268,"status":35,"city":269,"state":270,"zip":271,"country":42,"countryCode":43,"cosmosGeoPoint":272,"geoPoint":276,"contacts":35},"University of Wisconsin Hospital and Clinics","Madison","Wisconsin","53792",{"type":45,"coordinates":273},[274,275],-89.40123,43.07305,{"lat":275,"lon":274},{"facility":278,"status":35,"city":279,"state":35,"zip":35,"country":280,"countryCode":281,"cosmosGeoPoint":282,"geoPoint":286,"contacts":35},"McGill University Health Centre, Glen Site, Montreal Children's Hospital","Montreal","Canada","CA",{"type":45,"coordinates":283},[284,285],-73.58781,45.50884,{"lat":285,"lon":284},{"facility":288,"status":35,"city":289,"state":35,"zip":35,"country":280,"countryCode":281,"cosmosGeoPoint":290,"geoPoint":294,"contacts":35},"The Hospital for Sick Children","Toronto",{"type":45,"coordinates":291},[292,293],-79.39864,43.70643,{"lat":293,"lon":292},{"facility":296,"status":35,"city":297,"state":35,"zip":35,"country":280,"countryCode":281,"cosmosGeoPoint":298,"geoPoint":302,"contacts":35},"British Columbia's Children's Hospital","Vancouver",{"type":45,"coordinates":299},[300,301],-123.11934,49.24966,{"lat":301,"lon":300},{"type":304,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100331928","phase-3-safety-and-pharmacokinetic-study-of-lumacaftorivacaftor-in-participants-1-to-less-than-2-years-of-age-with-cystic-fibrosis-homozygous-for-f508del-100331928",true,"NCT03601637","Safety and Pharmacokinetic Study of Lumacaftor\u002FIvacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del","A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor\u002FIvacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del","Key Inclusion Criteria:\n\n* Participants will be 1 to less than 2 years of age on day 1 of the relevant part of the study\n* Homozygous for F508del (F\u002FF)\n\nKey Exclusion 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 participants\n* Solid organ or hematological transplantation\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","12 Months","23 Months",{"count":317,"type":318},61,"ACTUAL","INTERVENTIONAL",[321],"PHASE3","This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F\u002FF).",[324],"Cystic Fibrosis","COMPLETED","2022-12-14",{"date":328,"type":318},"2023-01-06",{"date":330,"type":318},"2018-09-07",{"date":332,"type":318},"2021-10-29",{"name":5,"class":6},27]