Avalglucosidase Alfa Pregnancy Study for Pompe Disease
This is an observational study looking at the safety of avalglucosidase alfa (a medicine for Pompe disease) when used during pregnancy and breastfeeding. Researchers want to understand any risks of avalglucosidase alfa for pregnant women and their babies. They will collect information on complications for the mother, the outcome of the pregnancy, and the health of the baby, including their growth and development for at least the first year of life. This study is open to women who have been exposed to avalglucosidase alfa during pregnancy or breastfeeding, and their babies. Data will be collected for about 10 years.
- Study design
- This is a worldwide, observational study that will collect information from 100 women and their offspring. It will look at past and future data.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for approximately 10 years to assess maternal complications, pregnancy outcomes, and infant outcomes.
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Avalglucosidase Alfa Pregnancy Study
At a glance
Conditions
NCT05734521
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Investigational site worldwide
Bridgewater, New Jerseyno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Clinical Sciences & Operations · STUDY_DIRECTOR · Sanofi
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- Maternal complicationsthrough study completion, an average of 10 years
Prevalence of pregnancy/labor/delivery/postpartum maternal complications
- Pregnancy outcomethrough study completion, an average of 10 years
Prevalence of live births, spontaneous abortions (\<20 weeks of gestation), elective terminations, ectopic pregnancies, early fetal deaths (20 to 27 weeks of gestation), late fetal deaths (≥28 weeks of gestation), stillbirths and maternal deaths
- Infant outcomethrough study completion, an average of 10 years
Number of occurrences of major congenital anomalies, neonatal deaths, development delays (growth, motor, neurologic, behavioral) through first year of life. Major congenital anomalies defined using the US Centers for Disease Control and Prevention (CDC) and growth and development assessments using CDC's Developmental Milestones 2021.