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

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Trial Status Recruiting

Trial Identifier

NCT05579548

Condition

Phenylketonuria, Phenylketonuria, Maternal

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial 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 Criteria

Birth Sex

Female

Age

Any

Healthy Volunteers

No

Drug/Treatment:

Pegvaliase

Study Type:

Observational

Number of Participants:

50

Study Started:

2022-11-22

Study Updated:

2024-05-03

Trial Locations

  • Syneos Health

    Wilmington, North Carolina, United States

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, , Germany

  • Ospedale San Paolo

    Milano, , Italy

Inclusion Criteria

  • 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 Criteria

• Currently participating in a BioMarin sponsored interventional study of any investigational product, device, or procedur

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