[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376612":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":30,"locations":31,"responsibleParty":233,"collaborators":30,"id":235,"slug":236,"hasResults":237,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":30,"eligibilityCriteria":241,"healthyVolunteers":242,"sex":243,"minAge":244,"maxAge":30,"enrollmentInfo":245,"targetDuration":30,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":30,"overallStatus":254,"whyStopped":30,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ELX\u002FTEZ\u002FIVA","EXPERIMENTAL","Participants greater than or equal to (≥) 6 years and less than (\\\u003C) 12 years of age and weighing \\\u003C30 kilograms (kg) received ELX (elexacaftor) 100 milligram (mg) once daily (qd) \u002FTEZ (tezacaftor) 50 mg qd\u002FIVA (ivacaftor) 75 mg every 12 hours (q12h) and those weighing (≥) 30 kg received ELX 200 mg qd\u002FTEZ 100 mg qd\u002FIVA 150 mg in the treatment period for up to 192 weeks. Participants ≥12 years of age received ELX 200 mg qd\u002F TEZ 100 mg qd\u002FIVA 150 mg q12h in the treatment period for up to 192 weeks.",[13,14],"Drug: ELX\u002FTEZ\u002FIVA","Drug: IVA",[16,23],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Fixed-dose combination (FDC) tablet for oral administration",[9],[21,22],"VX-445\u002FVX-661\u002FVX-770","elexacaftor\u002Ftezacaftor\u002Fivacaftor",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"IVA","Mono tablet for oral administration.",[9],[28,29],"VX-770","ivacaftor",null,[32,45,55,65,75,85,95,105,115,125,134,144,154,164,174,182,192,200,210,215,225],{"facility":33,"status":30,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":30},"Children's Hospital of Orange County","Orange","California","92868","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-117.85311,33.78779,{"lat":43,"lon":42},{"facility":46,"status":30,"city":47,"state":48,"zip":49,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":54,"contacts":30},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":40,"coordinates":51},[52,53],-104.83192,39.72943,{"lat":53,"lon":52},{"facility":56,"status":30,"city":57,"state":58,"zip":59,"country":37,"countryCode":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":30},"Ann & Robert Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":40,"coordinates":61},[62,63],-87.65005,41.85003,{"lat":63,"lon":62},{"facility":66,"status":30,"city":67,"state":68,"zip":69,"country":37,"countryCode":38,"cosmosGeoPoint":70,"geoPoint":74,"contacts":30},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":40,"coordinates":71},[72,73],-71.05977,42.35843,{"lat":73,"lon":72},{"facility":76,"status":30,"city":77,"state":78,"zip":79,"country":37,"countryCode":38,"cosmosGeoPoint":80,"geoPoint":84,"contacts":30},"Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"type":40,"coordinates":81},[82,83],-93.26384,44.97997,{"lat":83,"lon":82},{"facility":86,"status":30,"city":87,"state":88,"zip":89,"country":37,"countryCode":38,"cosmosGeoPoint":90,"geoPoint":94,"contacts":30},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"type":40,"coordinates":91},[92,93],-94.57857,39.09973,{"lat":93,"lon":92},{"facility":96,"status":30,"city":97,"state":98,"zip":99,"country":37,"countryCode":38,"cosmosGeoPoint":100,"geoPoint":104,"contacts":30},"Northwell Health- Long Island Jewish Medical Center","New Hyde Park","New York","11040",{"type":40,"coordinates":101},[102,103],-73.68791,40.7351,{"lat":103,"lon":102},{"facility":106,"status":30,"city":107,"state":108,"zip":109,"country":37,"countryCode":38,"cosmosGeoPoint":110,"geoPoint":114,"contacts":30},"Clinical Research of Charlotte","Charlotte","North Carolina","28277",{"type":40,"coordinates":111},[112,113],-80.84313,35.22709,{"lat":113,"lon":112},{"facility":116,"status":30,"city":117,"state":118,"zip":119,"country":37,"countryCode":38,"cosmosGeoPoint":120,"geoPoint":124,"contacts":30},"Rainbow Babies and Children's Hospital\u002FUniversity Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":40,"coordinates":121},[122,123],-81.69541,41.4995,{"lat":123,"lon":122},{"facility":126,"status":30,"city":127,"state":118,"zip":128,"country":37,"countryCode":38,"cosmosGeoPoint":129,"geoPoint":133,"contacts":30},"Nationwide Children's Hospital","Columbus","43205",{"type":40,"coordinates":130},[131,132],-82.99879,39.96118,{"lat":132,"lon":131},{"facility":135,"status":30,"city":136,"state":137,"zip":138,"country":37,"countryCode":38,"cosmosGeoPoint":139,"geoPoint":143,"contacts":30},"Oregon Health & Science University","Portland","Oregon","97239",{"type":40,"coordinates":140},[141,142],-122.67621,45.52345,{"lat":142,"lon":141},{"facility":145,"status":30,"city":146,"state":147,"zip":148,"country":37,"countryCode":38,"cosmosGeoPoint":149,"geoPoint":153,"contacts":30},"Texas Children's Hospital","Houston","Texas","77030",{"type":40,"coordinates":150},[151,152],-95.36327,29.76328,{"lat":152,"lon":151},{"facility":155,"status":30,"city":156,"state":157,"zip":158,"country":37,"countryCode":38,"cosmosGeoPoint":159,"geoPoint":163,"contacts":30},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":40,"coordinates":160},[161,162],-122.33207,47.60621,{"lat":162,"lon":161},{"facility":165,"status":30,"city":166,"state":30,"zip":30,"country":167,"countryCode":168,"cosmosGeoPoint":169,"geoPoint":173,"contacts":30},"Queensland Children's Hospital","South Brisbane","Australia","AU",{"type":40,"coordinates":170},[171,172],153.02049,-27.48034,{"lat":172,"lon":171},{"facility":175,"status":30,"city":176,"state":30,"zip":30,"country":167,"countryCode":168,"cosmosGeoPoint":177,"geoPoint":181,"contacts":30},"The Children's Hospital at Westmead","Westmead",{"type":40,"coordinates":178},[179,180],150.98768,-33.80383,{"lat":180,"lon":179},{"facility":183,"status":30,"city":184,"state":30,"zip":30,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":191,"contacts":30},"The Hospital for Sick Children","Toronto","Canada","CA",{"type":40,"coordinates":188},[189,190],-79.39864,43.70643,{"lat":190,"lon":189},{"facility":193,"status":30,"city":194,"state":30,"zip":30,"country":185,"countryCode":186,"cosmosGeoPoint":195,"geoPoint":199,"contacts":30},"British Columbia's Children's Hospital","Vancouver",{"type":40,"coordinates":196},[197,198],-123.11934,49.24966,{"lat":198,"lon":197},{"facility":201,"status":30,"city":202,"state":30,"zip":30,"country":203,"countryCode":204,"cosmosGeoPoint":205,"geoPoint":209,"contacts":30},"Children's Health Ireland at Crumlin","Dublin","Ireland","IE",{"type":40,"coordinates":206},[207,208],-6.24889,53.33306,{"lat":208,"lon":207},{"facility":211,"status":30,"city":202,"state":30,"zip":30,"country":203,"countryCode":204,"cosmosGeoPoint":212,"geoPoint":214,"contacts":30},"Children's Health Ireland at Temple Street",{"type":40,"coordinates":213},[207,208],{"lat":208,"lon":207},{"facility":216,"status":30,"city":217,"state":30,"zip":30,"country":218,"countryCode":219,"cosmosGeoPoint":220,"geoPoint":224,"contacts":30},"Birmingham Children's Hospital - NHS Foundation Trust","Birmingham","United Kingdom","UK",{"type":40,"coordinates":221},[222,223],-1.89983,52.48142,{"lat":223,"lon":222},{"facility":226,"status":30,"city":227,"state":30,"zip":30,"country":218,"countryCode":219,"cosmosGeoPoint":228,"geoPoint":232,"contacts":30},"Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital","London",{"type":40,"coordinates":229},[230,231],-0.12574,51.50853,{"lat":231,"lon":230},{"type":234,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100376612","phase-3-evaluation-of-long-term-safety-and-efficacy-of-elxteziva-tc-combination-therapy-in-participants-with-cystic-fibrosis-who-are-6-years-of-age-and-older-100376612",true,"NCT04183790","Evaluation of Long-term Safety and Efficacy of ELX\u002FTEZ\u002FIVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older","A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of ELX\u002FTEZ\u002FIVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older","Key Inclusion Criteria:\n\n* Completed study drug treatment in parent study (VX18-445-106 Part B, NCT03691779), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study\n\nKey Exclusion Criteria:\n\n* History of study drug intolerance in parent study\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","6 Years",{"count":246,"type":247},64,"ACTUAL","INTERVENTIONAL",[250],"PHASE3","The study evaluates the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in participants with cystic fibrosis (CF).",[253],"Cystic Fibrosis","COMPLETED","2025-05-01",{"date":257,"type":247},"2025-05-18",{"date":259,"type":247},"2020-02-17",{"date":261,"type":247},"2024-02-24",{"name":5,"class":6},21]