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

NCT05579548 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Phenylketonuria, Maternal

Interventions

DRUG

Pegvaliase

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director, MD · BioMarin Pharmaceutical

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2032-10-04
Completion
2032-10-04
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579548 on ClinicalTrials.gov