Safety Study of Avalglucosidase Alfa Use During Pregnancy and Lactation in Women with Pompe Disease and Their Infants

What this Trial Is About

Researchers are collecting safety data worldwide on women and their babies who have been exposed to avalglucosidase alfa during pregnancy and breastfeeding. The study aims to understand the potential risks of avalglucosidase alfa on pregnancy outcomes, maternal health issues, and any adverse effects on the developing fetus, newborn, and infant. This observational study looks at both past and current exposures to gather comprehensive safety information. The study focuses on pregnant women diagnosed with Pompe disease who have received avalglucosidase alfa either during pregnancy or lactation, as well as infants born to parents with Pompe disease who were exposed to the drug. Avalglucosidase alfa is given through intravenous infusion, and exposure is tracked through reports submitted to the study sponsor and patient registries. There are no comparison groups since this is an observational safety study. Participants will be followed for about 10 years to collect data on maternal complications, pregnancy outcomes, and infant health. Infant growth and development will be closely monitored for at least the first year of life. The study relies on safety reports and registry data to assess the long-term effects of avalglucosidase alfa exposure during pregnancy and breastfeeding.

Avalglucosidase Alfa Pregnancy Study