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
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
Inclusion Criteria5
- Subject (or a legally authorized representative) consent obtained prior to enrollment. Consent will be obtained in compliance with any country-specific regulations or requirements
- 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 Criteria1
- Currently participating in a BioMarin sponsored interventional study of any investigational product, device, or procedure
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Interventions
DRUGPegvaliase
Pregnant women exposed to pegvaliase within 2 weeks prior to LMP.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05579548