A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
Recruiting
- Conditions
- Phenylketonuria (PKU)
- Registration Number
- NCT06305234
- Lead Sponsor
- BioMarin Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Inclusion Criteria:<br><br> - Subjects enrolled at US sites participating in the 165-501 study.<br><br>Exclusion Criteria:<br><br> - Legal incapacity or limited legal capacity without legal guardian representation.<br><br> - Subject is unable or unwilling to provide informed consent for the additional<br> interventional burden of the study (blood sampling).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate immunologic and inflammatory responses associated with occurrences of
- Secondary Outcome Measures
Name Time Method Evaluation of immunologic and/or inflammatory responses over time;Evaluation of immunologic responses over time