A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
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.
- EligibilityCriteria: Inclusion Criteria:  Subjects enrolled at US sites participating in the 165-501 study.  Exclusion Criteria:  Legal incapacity or limited legal capacity without legal guardian representation. Subject is unable or unwilling to provide informed consent for the additional interventional burden of the study (blood sampling). - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Subjects enrolled at US sites participating in the 165-501 study. - SamplingMethod: Non-Probability Sample