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Study identifier: NCT05579548 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding

Condition: Phenylketonuria, Maternal  ·  Sponsor: BioMarin Pharmaceutical

PhaseN/A
Planned participants50
Who can joinFemale, N/A to no upper limit
Healthy volunteersNo

About this study

This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and breastfeeding.

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

Talk to the study team

165-504 Program Director  ·  1-800-983-4587  ·  medinfo@bmrn.com

Always discuss trial participation with your own doctor first.

Locations (4)

Syneos HealthWilmington, North Carolina, United StatesRecruiting
Metabolics and Genetics in Calgary (MAGIC)Calgary, CanadaRecruiting
Universitaetsklinikum Hamburg EppendorfHamburg, GermanyRecruiting
Ospedale San PaoloMilan, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT05579548