RecruitingNCT05579548

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

Sponsor

BioMarin Pharmaceutical

Enrollment

50 participants

Start Date

Nov 22, 2022

Study Type

OBSERVATIONAL

Conditions

Phenylketonuria, Maternal

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.

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pegvaliase for people with phenylketonuria, maternal. The study is currently recruiting participants at 4 locations. People eligible for this study include women.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPegvaliase

Pregnant women exposed to pegvaliase within 2 weeks prior to LMP.

Locations(4)

Syneos Health

Wilmington, North Carolina, United States

Metabolics and Genetics in Calgary (MAGIC)

Calgary, Canada

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Ospedale San Paolo

Milan, Italy

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NCT05579548