[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100330878":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":58,"collaborators":28,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":28,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":28,"enrollmentInfo":70,"targetDuration":28,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":28,"overallStatus":37,"whyStopped":28,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Symdeko","EXPERIMENTAL","Patients who have a mutation that responds to a CFTR corrector from in vitro study will be given Symdeko, depending on the in vitro response pattern",[13],"Drug: Symdeko",{"label":15,"type":10,"description":16,"interventionNames":17},"Ivacaftor","Patients who have mutation response to a potentiator of CFTR function will be given Ivacaftor monotherapy.. Patients with a mutation equivalent to wild type will be given Ivacaftor.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Orkambi","Patients who have a mutation that responds to a CFTR corrector from in vitro study will be given Orkambi, depending on the in vitro response pattern",[13],[23],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.",[15,19,9],[19,15],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Heather Hathorne, PhD","CONTACT","205-638-9568","hhathorne@peds.uab.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-86.80249,33.52066,{"lat":47,"lon":46},[50,51,55],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},{"name":52,"role":32,"phone":53,"phoneExt":28,"email":54},"Ginger Reeves, BS","205-638-5970","greeves@peds.uab.edu",{"name":56,"role":57,"phone":28,"phoneExt":28,"email":28},"George Solomon, MD","PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","George Solomon","Principal Investigator","100330878","early-phase-1-personalized-theratyping-trial-100330878",false,"NCT03587961","Personalized Theratyping Trial","Inclusion Criteria:\n\n* Diagnosis of CF\n* Age ≥6 y.o.\n* CFTR mutation that may respond to approved correctors\u002Fpotentiators in the opinion of the study investigators\n* Informed Consent\u002FAssent\n* Stable CF pulmonary regimen\n\nExclusion Criteria:\n\n* Exacerbation requiring antibiotic or steroids for \\>28 days before trial entry\n* Ongoing participation in a CFTR modulator study\n* Active smoking in the past 6 months\n* History of solid organ transplant\n* Any condition which precludes the use of CFTR modulators: e.g. advanced cirrhosis, End-stage Renal Disease (ESRD)\n* Any condition that precludes the patient from participation in the opinion of the investigator\n* Any meds that have significant drug-drug interactions or any other off label use of CFTR modulators","ALL","6 Years",{"count":71,"type":72},20,"ESTIMATED","INTERVENTIONAL",[75],"EARLY_PHASE1","The purpose of this study is to explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.",[78],"Cystic Fibrosis","2026-01-29",{"date":81,"type":82},"2026-02-02","ACTUAL",{"date":84,"type":82},"2019-08-01",{"date":86,"type":72},"2027-09-01",{"name":60,"class":6},1]