[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sonya Heltshe\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100401577","study-to-evaluate-biological--clinical-effects-of-significantly-corrected-cftr-function-in-infants--young-children-100401577",false,"NCT04509050","Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children","A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study)","BEGIN","Inclusion Criteria:\n\n* Part A:\n\n  * Less than 10 years of age at the first study visit.\n  * Documentation of a CF diagnosis.\n\nPart B:\n\n* Participated in Part A OR less than 7 years of age at the first study visit.\n* Documentation of a CF diagnosis.\n* CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor).\n* Physician intent to prescribe ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor.\n\nExclusion Criteria:\n\n* Part A and Part B:\n* Use of an investigational drug within 28 days prior to and including the first study visit.\n* Use of ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor within the 28 days prior to and including the first study visit.\n* Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.","ALL","10 Years",{"count":20,"type":21},210,"ESTIMATED","OBSERVATIONAL","This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).",[25],"Cystic Fibrosis",[25,27,28,29,30,31,32],"CF","CFTR Modulator","triple combination therapy","elexacaftor","tezacaftor","ivacaftor","RECRUITING","2026-07-06",{"date":36,"type":37},"2026-07-08","ACTUAL",{"date":39,"type":37},"2020-11-18",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Sonya Heltshe","OTHER",35,""]