[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"phenylketonuria-pku-and-hyperphenylalaninemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:phenylketonuria-pku-and-hyperphenylalaninemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100654647","acceptability-and-tolerance-market-research-of-a-slow-release-phenylalanine-free-protein-substitute-for-the-dietary-management-of-phenylketonuria-100654647",false,"NCT07802366","Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU","XPhe Piccos - Acceptability and Tolerance Market Research","XPhePiccosMR","Inclusion Criteria:\n\n* Diagnosis of PKU or HPA requiring a phenylalanine-free protein substitute.\n* Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days.\n* Subjects aged 3 years and above.\n* Written informed assent\u002Fconsent obtained from subject and\u002For parental caregiver, depending on subject age.\n\nExclusion Criteria:\n\n* Presence of serious concurrent illness.\n* Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.\n* Any subject having taken antibiotics over the previous 2 weeks leading up to the study.\n* Subjects less than 3 years of age","ALL","3 Years","18 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"NA","XPhePiccosMR is a prospective, single-arm, open label, observational study that aims to evaluate the acceptability and tolerability of XPhe Piccos, a slow-release, phenylalanine-free protein substitute in the form of tiny tablets, for use in the dietary management of phenylketonuria (PKU) in children aged three years and older.",[28,29,30,31,32,33,34,35,36,37,38,39],"Phenylketonuria (PKU) and Hyperphenylalaninemia","Brain Diseases, Metabolic, Inborn","Brain Disorder, Metabolic","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Amino Acid Metabolism, Inborn Errors","Metabolism, Inborn Errors","Genetic Disease, Inborn","Genetic Diseases, Inborn","Metabolic Diseases","Nutritional and Metabolic Diseases",[41,42,43,44,45],"PKU","HPA","protein substitute","7-day trial","slow release","NOT_YET_RECRUITING","2026-10-06",{"date":49,"type":50},"2026-10-09","ACTUAL",{"date":52,"type":22},"2026-10-15",{"date":54,"type":22},"2027-08-01",{"name":56,"class":57},"metaX Institut fuer Diatetik GmbH","INDUSTRY",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":5},"100635379","phecheck-validation-study-100635379","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","1 Year",{"count":67,"type":22},60,"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).",[28],[72,41,73,74],"Phenylketonuria","Hyperphenylalaninemia","Phenylalanine","RECRUITING","2026-08-24",{"date":78,"type":50},"2026-08-25",{"date":80,"type":50},"2026-08-20",{"date":82,"type":22},"2027-04-20",{"name":84,"class":57},"Aptatek BioSciences, Inc"]