Actively Recruiting
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
Led by BioMarin Pharmaceutical · Updated on 2026-03-24
200
Participants Needed
11
Research Sites
512 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects enrolled at US sites participating in the 165-501 study.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Riley Children's Hospital/ Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Actively Recruiting
6
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
8
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
9
Vanderbilt University Medical School
Nashville, Tennessee, United States, 37235
Actively Recruiting
10
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
Children's Wisconsin/Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
1
165-503 Program Director
CONTACT
M
Medical Director, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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