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.
Phenylketonuria (PKU)
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.
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
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University of Colorado, Aurora, Colorado, United States, 80045
Northwestern University, Chicago, Illinois, United States, 60611
Tulane University School of Medicine, New Orleans, Louisiana, United States, 70112
Oregon Health & Science University, Portland, Oregon, United States, 97239
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213
UT Southwestern Medical Center, Dallas, Texas, United States, 75390
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
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BioMarin Pharmaceutical,
Medical Director, MD, STUDY_DIRECTOR, BioMarin Pharmaceutical
2033-11-18