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

Recruiting Observational Study
Phenylketonuria (PKU)
No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Any
Study type
Observational
Participants needed
450 (estimated)
Sponsor
BioMarin Pharmaceutical · Industry
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About This Trial
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 m…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of PKU per local standard of care * Currently receiving or planned to receive pegvaliase treatment within 30 days after the date of enrollment, including subjects who previously received pegvaliase as part of the clinical development program and have compl…
Contacts

165-501 Program Director

1-800-983-4587

medinfo@bmrn.com

CONTACT

Medical Director, MD

1-800-983-4587

medinfo@bmrn.com

CONTACT