A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
Eligible age
All ages
Accepts
All genders
Locations
11 states
Healthy volunteers
No
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About this study
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.
Sponsor: BioMarin Pharmaceutical
You may qualify if…
- ✓ Subjects enrolled at US sites participating in the 165-501 study.
You may not qualify if…
- ✕ 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).
Where it's recruiting
Source: ClinicalTrials.gov · NCT06305234 · last updated 2026-03-24