Actively Recruiting
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
Led by BioMarin Pharmaceutical · Updated on 2026-03-24
50
Participants Needed
4
Research Sites
514 weeks
Total Duration
On this page
Sponsors
B
BioMarin Pharmaceutical
Lead Sponsor
S
Syneos Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legally authorized representative consent obtained before enrollment
- Confirmed ongoing pregnancy, including prospective or retrospective based on prenatal testing
- Diagnosed with phenylketonuria (PKU) according to local care standards
- Treated with pegvaliase starting from 2 weeks before the last menstrual period
- Agrees to let study staff contact healthcare providers for medical information
You will not qualify if you...
- Currently participating in a BioMarin sponsored interventional study involving investigational products, devices, or procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Syneos Health
Wilmington, North Carolina, United States, 28403
Actively Recruiting
2
Metabolics and Genetics in Calgary (MAGIC)
Calgary, Canada, T2E 7Z4
Actively Recruiting
3
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
4
Ospedale San Paolo
Milan, Italy, 20142
Actively Recruiting
Research Team
1
165-504 Program Director
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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