{ "Observational Study of Palynziq (Pegvaliase) During Pregnancy and Breastfeeding", "This is an observational study looking at the effects of Palynziq (pegvaliase) on pregnant women with Phenylketonuria (PKU), a genetic condition, and on their babies. Researchers want to understand the outcomes for mothers and infants when the mother has been treated with Palynziq within two weeks before her last menstrual period. The study aims to track pregnancy outcomes and how babies develop over 10 years. Women who are pregnant and have been prescribed pegvaliase by their doctor can join. The study is currently unclear about its recruitment status and plans to enroll 50 participants.", "design": "This is an observational study, meaning researchers will watch and collect information without giving any specific treatment. It is a global, multicenter study planning to enroll 50 participants.", "commitments": "You would enroll through a call center, and data would be collected from your healthcare providers for at least 3 months before your last menstrual period. Data will also be collected during your pregnancy and your baby's first year of life, for a total participation of up to approximately 21 months.", "compensation": "Not stated in the trial record.", "follow_up": "Your pregnancy outcome and infant development will be measured for up to 10 years after the last menstrual period.", }

Study design

Not specified.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.