[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aptatek BioSciences, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100635379","phecheck-validation-study-100635379",false,"NCT07551921","PheCheck™ Validation Study","Inclusion Criteria:\n\n* 1 year or older and able to have a fingerstick blood collected\n* Being monitored for Phenylketonuria (classical PKU, mild PKU, variant PKU, or hyperphenylalaninemia)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous enrollment in the study and has completed 3 study visits\n* Inability to read and understand instructions","ALL","1 Year",{"count":18,"type":19},60,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or hyperphenylalaninemia. The main objective is comparing the concentration of phenylalanine (Phe) in capillary blood with the reference method (DBS).",[23],"Phenylketonuria (PKU) and Hyperphenylalaninemia",[25,26,27,28],"Phenylketonuria","PKU","Hyperphenylalaninemia","Phenylalanine","RECRUITING","2026-08-24",{"date":32,"type":33},"2026-08-25","ACTUAL",{"date":35,"type":33},"2026-08-20",{"date":37,"type":19},"2027-04-20",{"name":39,"class":40},"Aptatek BioSciences, Inc","INDUSTRY",2,""]