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Study identifier: NCT05813678 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)

Condition: Phenylketonuria (PKU)  ·  Sponsor: BioMarin Pharmaceutical

PhaseN/A
Planned participants450
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

This is a 10-year multi-center, global, observational study to further characterize the safety profile of pegvaliase, including hypersensitivity reactions, long-term safety and tolerability, and the effectiveness of the additional risk minimization measures (aRMMs) (European Union (EU) only) in subjects receiving pegvaliase for the treatment of PKU. Subjects 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 (incident-users) or have previously started treatment with pegvaliase at the date of enrollment (prevalent-users) are eligible for participation in this study.

This description comes directly from the study's public registry record.

Talk to the study team

165-501 Program Director  ·  1-800-983-4587  ·  medinfo@bmrn.com

Medical Director, MD  ·  1-800-983-4587  ·  medinfo@bmrn.com

Always discuss trial participation with your own doctor first.

Locations (26)

University of ColoradoAurora, Colorado, United StatesRecruiting
Emory UniversityAtlanta, Georgia, United StatesRecruiting
Northwestern UniversityChicago, Illinois, United StatesRecruiting
Indiana University School of MedicineIndianapolis, Indiana, United StatesRecruiting
Tulane University Medical CenterNew Orleans, Louisiana, United StatesRecruiting
Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Oregon Health and Science UniversityPortland, Oregon, United StatesRecruiting
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania, United StatesRecruiting
Vanderbilt University Medical SchoolNashville, Tennessee, United StatesRecruiting
University of Texas Southwestern Medical CenterDallas, Texas, United StatesRecruiting
University of UtahSalt Lake City, Utah, United StatesRecruiting
Medical College of WisconsinMilwaukee, Wisconsin, United StatesRecruiting

+ 14 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05813678