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A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)

Recruitingn/aAges any - anyAllBioMarin Pharmaceutical
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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).
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What it tests

  • Pegvaliase
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Where

11 sites
University of Colorado
Aurora, United States
Emory University
Atlanta, United States
Northwestern University
Chicago, United States
Riley Children's Hospital/ Indiana University Health
Indianapolis, United States
Tulane University School of Medicine
New Orleans, United States
Boston Children's Hospital
Boston, United States
Oregon Health & Science University
Portland, United States
University of Pittsburgh Medical Center
Pittsburgh, United States

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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