Clinical Trial

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

Study acronym: PALomino
Recruiting
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-10-11; most recent amendment 2026-03-20.
Trial Details
NCT Number NCT05579548
Lead Sponsor BioMarin Pharmaceutical
Collaborators: Syneos Health
Conditions Phenylketonuria, Maternal
Enrollment 50 participants
Start Date 2022-11-22
Primary Completion 2032-10-04 (estimated)
Study Completion 2032-10-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-24