Status: Recruiting
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
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.
Participants needed: 50
Trial details
Biological sex: FemaleType: ObservationalSponsor: BioMarin PharmaceuticalUpdated: Mar 24, 2026Locations: 4
Eligibility criteria
Subject (or a legally authorized representative) consent obtained prior to enrol... [+4]