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

Conditions

• Phenylketonuria, Maternal

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Pegvaliase — DRUG
  Pregnant women exposed to pegvaliase within 2 weeks prior to LMP.

Study Details

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.

Key Dates

Start date

Nov 22, 2022

Status verified

Mar 2026

Primary completion

Oct 4, 2032

Completion

Oct 4, 2032

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Pregnancy outcome and infant development for women who have been treated with Palynziq (pegvaliase) within 2 weeks of their last menstrual period [ Time Frame: 10 years ]

Central Contacts

• 165-504 Program Director
  1-800-983-4587
  [email protected]

Locations (1)

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