Status:
RECRUITING
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
Lead Sponsor:
BioMarin Pharmaceutical
Conditions:
Phenylketonuria (PKU)
Eligibility:
All Genders
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
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).
Key Trial Info
Start Date :
January 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 18 2033
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06305234
Start Date
January 20 2024
End Date
November 18 2033
Last Update
March 24 2026
Active Locations (11)
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1
University of Colorado
Aurora, Colorado, United States, 80045
2
Emory University
Atlanta, Georgia, United States, 30322
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Riley Children's Hospital/ Indiana University Health
Indianapolis, Indiana, United States, 46202