[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539545":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":24,"responsibleParty":139,"collaborators":7,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":7,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":7,"maxAge":7,"enrollmentInfo":149,"targetDuration":7,"studyType":152,"phases":7,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"BioMarin Pharmaceutical","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Pegvaliase","Must be enrolled in the 165-501 PALace study. 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Center","Dallas","Texas","75390",{"type":34,"coordinates":125},[126,127],-96.80667,32.78306,{"lat":127,"lon":126},{"facility":130,"status":27,"city":131,"state":132,"zip":133,"country":31,"countryCode":32,"cosmosGeoPoint":134,"geoPoint":138,"contacts":7},"Children's Wisconsin\u002FMedical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":34,"coordinates":135},[136,137],-87.90647,43.0389,{"lat":137,"lon":136},{"type":140,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100539545","a-long-term-post-marketing-study-of-immune-response-in-patients-receiving-palynziq-treatment-for-pku-palisade-100539545",false,"NCT06305234","A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)","A Multi-Center, Prospective, Longitudinal, Study Evaluating Immunologic, Inflammatory, and Laboratory Parameters Associated With Long-Term Palynziq® (Pegvaliase) Treatment in Subjects With Phenylketonuria (PKU) in the United States","Inclusion Criteria:\n\n* Subjects enrolled at US sites participating in the 165-501 study.\n\nExclusion Criteria:\n\n* Legal incapacity or limited legal capacity without legal guardian representation.\n* Subject is unable or unwilling to provide informed consent for the additional interventional burden of the study (blood sampling).","ALL",{"count":150,"type":151},200,"ESTIMATED","OBSERVATIONAL","This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503.",[155],"Phenylketonuria (PKU)",[157,158,159,160,161,162,163,164],"PKU","Phenylketonuria","Palynziq","pegvaliase","observational","safety study","immunogenicity assessment","inflammatory assessment","2026-03-20",{"date":167,"type":168},"2026-03-24","ACTUAL",{"date":170,"type":168},"2024-01-20",{"date":172,"type":151},"2033-11-18",{"name":5,"class":6},11]