[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604378":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":89,"collaborators":92,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":27,"enrollmentInfo":108,"targetDuration":27,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":44,"whyStopped":27,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Arkansas Children's Hospital Research Institute","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Single Arm","Participants may be enrolled in an observational one-visit study for association of concentration with side effects. Participants may proceed to a single arm study if they have side effects to assess the feasibility of adjusting dose to maintain concentrations within an estimated effective range. Once within the range, dosing is no longer adjusted. Side effects will be evaluated as described in the protocol.",[12,13],"Drug: Elexacaftor \u002F Ivacaftor \u002F Tezacaftor","Other: therapeutic drug monitoring",[15,23],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Elexacaftor \u002F Ivacaftor \u002F Tezacaftor","This study will examine different dosing strategies and outcomes for triple combination CFTR modulator therapy using the drug(s) elexacaftor, tezacaftor, and\u002For ivacaftor in patients with cystic fibrosis.",[9],[21,22],"Triple Combination CFTR Modulator Therapy","ETI - Elexacaftor\u002FTezacaftor\u002FIvacaftor",{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"therapeutic drug monitoring","Participants who consent to the therapeutic drug monitoring study will have their dose adjusted to remain within estimated effective concentrations.",[9],null,[29],{"name":30,"affiliation":5,"role":31},"Jennifer S Guimbellot, Medical Degree and License","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":27,"email":36},"CONTACT","501-364-5365","jguimbellot@uams.edu",{"name":38,"role":34,"phone":39,"phoneExt":27,"email":40},"Michelle Gillespie","501-364-3377","GillespieM@archildrens.org",[42,59,76],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-86.80249,33.52066,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":27,"phoneExt":27,"email":27},"Stefanie Krick, MD",{"facility":60,"status":44,"city":61,"state":62,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Arkansas Children's Hospital","Little Rock","Arkansas","72205",{"type":51,"coordinates":65},[66,67],-92.28959,34.74648,{"lat":67,"lon":66},[70,72,75],{"name":71,"role":34,"phone":39,"phoneExt":27,"email":40},"Michelle Gillespie, Research Coordinator",{"name":73,"role":34,"phone":27,"phoneExt":27,"email":74},"Bianca Johnson, Supervisor Pulmonary Research, MPH","JohnsonB2@archildrens.org",{"name":30,"role":31,"phone":27,"phoneExt":27,"email":27},{"facility":77,"status":44,"city":78,"state":79,"zip":80,"country":48,"countryCode":49,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University of Washington","Seattle","Washington","98195",{"type":51,"coordinates":82},[83,84],-122.33207,47.60621,{"lat":84,"lon":83},[87],{"name":88,"role":34,"phone":27,"phoneExt":27,"email":27},"Kathleen Ramos, MD",{"type":31,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Jennifer Guimbellot","Principal Investigator - MD",[93,96],{"name":94,"class":95},"National Institutes of Health (NIH)","NIH",{"name":97,"class":95},"National Heart, Lung, and Blood Institute (NHLBI)","100604378","phase-4-ensuring-access-to-optimal-therapy-in-cf-the-enact-study-100604378",false,"NCT07148739","Ensuring Access to Optimal Therapy in CF: The ENACT Study","Ensuring Access to Optimal Therapy in Cystic Fibrosis: The ENACT Study","ENACT","Inclusion Criteria:\n\n* documentation of CF diagnosis per CFF diagnostic criteria and known CFTR genotype\n* age 2 years and older\n* ability to provide written informed consent and\u002For assent (by subject and\u002For legal guardian)\n* on a stable dose of triple combination CFTR modulator therapy for at least two weeks prior to Visit 1\n* clinically stable lung disease, defined as no documented acute decrease in FEV1 \\> 10%, OR use of additional antibiotics (intravenous \\[IV\\] or oral \\[PO\\]) within 4 weeks prior to screening\n\nExclusion Criteria:\n\n* recent significant unintentional weight loss, as determined by the investigator, in the 4 weeks prior to screening\n* pregnant or breastfeeding female\n* history of alcohol or substance abuse in the 6 months prior to screening\n* participation in a study involving an investigational intervention within 28 days (or 5 half-lives, whichever is longer) prior to screening\n* in the opinion of the Investigator, medical or psychiatric illness, or other conditions that would interfere with participation","ALL","3 Years",{"count":109,"type":110},100,"ESTIMATED","INTERVENTIONAL",[113],"PHASE4","This clinical trial is examining the action and effects of several new drugs in the treatment of cystic fibrosis in children. In addition, several genetic factors are examined. The hope is that the ability to determine prior to treatment those individuals who will or will not respond to existing therapies will avoid needless risk of side effects and the high cost of a potentially ineffective treatment regimen. Understanding the way these drugs work in the body and the best way to study them is critical to expanding the use of these drugs to all patients with cystic fibrosis (CF).",[116],"Cystic Fibrosis (CF)",[118,119,120,121,122,123,124],"Cystic Fibrosis","CF","CFTR modulator","Pediatric CF patients","Elexacaftor","Tezacaftor","Ivacaftor","2026-05-29",{"date":127,"type":128},"2026-06-02","ACTUAL",{"date":130,"type":128},"2025-06-10",{"date":132,"type":110},"2030-12",{"name":5,"class":6},3]