[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100333756":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":41,"locations":42,"responsibleParty":86,"collaborators":41,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":41,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":41,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":41,"overallStatus":108,"whyStopped":41,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Placebo","PLACEBO_COMPARATOR","Participants received placebo matched to LUM\u002FIVA in placebo-controlled period for 48 weeks.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Part 1: LUM\u002FIVA","EXPERIMENTAL","Participants weighing less than (\\\u003C)14 kilograms (kg) at screening received LUM 100 milligrams (mg)\u002FIVA 125 mg fixed-dose combination (FDC) every 12 hours (q12h) in placebo-controlled period for 48 weeks. Participants weighing greater than or equals to (\\>=)14 kg at screening received LUM 150 mg\u002FIVA 188 mg FDC q12h in placebo-controlled period for 48 weeks.",[19],"Drug: LUM\u002FIVA",{"label":21,"type":16,"description":22,"interventionNames":23},"Part 2: Overall LUM\u002FIVA","Participants who received either placebo or LUM\u002FIVA in placebo-controlled period administered LUM\u002FIVA (either LUM 100 mg\u002FIVA 125 mg FDC q12h or LUM 150 mg\u002FIVA 188 mg FDC q12h as per their body weight for participants \\\u003C6 years of age at week 48 and LUM 200 mg\u002FIVA 250 mg FDC q12h regardless of their body weight for participants \\>=6 years of age at week 48) in open-label period for 48 weeks.",[19],[25,33,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","LUM\u002FIVA","FDC tablets or granules for oral administration.",[21],[31,32],"Lumacaftor\u002FIvacaftor","VX-809\u002FVX-770",{"type":26,"name":27,"description":34,"armGroupLabels":35,"otherNames":36},"FDC granules for oral administration.",[15],[31,32],{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Placebo","Placebo matched to LUM\u002FIVA for oral administration.",[9],null,[43,54,62,70,78],{"facility":44,"status":41,"city":45,"state":41,"zip":41,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":41},"Charite Paediatric Pulmonology Department","Berlin","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],13.41053,52.52437,{"lat":52,"lon":51},{"facility":55,"status":41,"city":56,"state":41,"zip":41,"country":46,"countryCode":47,"cosmosGeoPoint":57,"geoPoint":61,"contacts":41},"Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin","Giessen",{"type":49,"coordinates":58},[59,60],8.67554,50.58727,{"lat":60,"lon":59},{"facility":63,"status":41,"city":64,"state":41,"zip":41,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":41},"Hannover Medical School","Hanover",{"type":49,"coordinates":66},[67,68],9.73322,52.37052,{"lat":68,"lon":67},{"facility":71,"status":41,"city":72,"state":41,"zip":41,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":41},"Heidelberg Cystic Fibrosis Center","Heidelberg",{"type":49,"coordinates":74},[75,76],8.69079,49.40768,{"lat":76,"lon":75},{"facility":79,"status":41,"city":80,"state":41,"zip":41,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":41},"Universitatsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin","Lübeck",{"type":49,"coordinates":82},[83,84],10.68729,53.86893,{"lat":84,"lon":83},{"type":87,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100333756","phase-2-a-study-to-explore-the-impact-of-lumacaftorivacaftor-on-disease-progression-in-subjects-aged-2-through-5-years-with-cystic-fibrosis-homozygous-for-f508del-100333756",true,"NCT03625466","A Study to Explore the Impact of Lumacaftor\u002FIvacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del","An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor\u002FIvacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del","Key Inclusion Criteria:\n\n* Subjects with confirmed diagnosis of CF.\n* Homozygous for F508del (F\u002FF).\n* Subjects who weigh ≥8 kg without shoes and wearing light clothing at the Screening Visit.\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 subject.\n* Solid organ or hematological transplantation.\n* History of any illness or comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study.\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","2 Years","5 Years",{"count":100,"type":101},51,"ACTUAL","INTERVENTIONAL",[104],"PHASE2","This study will explore the impact of lumacaftor\u002Fivacaftor (LUM\u002FIVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F\u002FF).",[107],"Cystic Fibrosis","COMPLETED","2022-10-06",{"date":111,"type":101},"2022-11-02",{"date":113,"type":101},"2018-08-10",{"date":115,"type":101},"2021-10-07",{"name":5,"class":6},5]