A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
NCT ID: NCT05579548
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-11-22
2032-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant Women with PKU
This study will enroll pregnant women diagnosed with PKU who have been treated with pegvaliase from 2 weeks prior to LMP or at any time during pregnancy.
Pegvaliase
Pregnant women exposed to pegvaliase within 2 weeks prior to LMP.
Interventions
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Pegvaliase
Pregnant women exposed to pegvaliase within 2 weeks prior to LMP.
Eligibility Criteria
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Inclusion Criteria
* Confirmation of ongoing pregnancy. Subjects with unknown outcomes will be classified as prospective pregnancies; subjects who have undergone prenatal testing (eg, targeted ultrasound, amniocentesis) regardless of findings will be classified as retrospective pregnancies
* Diagnosed with PKU per local standard of care
* Documentation that the subject was treated with pegvaliase at any point starting from 2 weeks prior to the date of LMP
* Agrees to permit the Investigator (ie, CRP, CCA, PI) to contact the subject's HCPs (eg, PCP, PKU-treating physician, OB, nurse, midwife) and the infant's HCP (eg, pediatrician, neonatologist) for medical information
Exclusion Criteria
FEMALE
No
Sponsors
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Syneos Health
OTHER
BioMarin Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
BioMarin Pharmaceutical
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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165-504
Identifier Type: -
Identifier Source: org_study_id
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