Actively Recruiting
Avalglucosidase Alfa Pregnancy Study
Led by Sanofi · Updated on 2026-01-16
100
Participants Needed
1
Research Sites
522 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal complications and adverse effects in the developing fetus, neonate, and infant. * Outcomes in exposed infants, including growth and development, will be assessed through at least the first year of life. * Data will be collected for approximately 10 years.
CONDITIONS
Official Title
Avalglucosidase Alfa Pregnancy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and their babies exposed to avalglucosidase alfa during pregnancy and/or breastfeeding with a safety report submitted to Sanofi Global Pharmacovigilance, and/or
- Women exposed to avalglucosidase alfa during pregnancy and/or breastfeeding who agree to enroll in the Pompe Pregnancy Sub-registry
You will not qualify if you...
- There are no exclusion criteria in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Investigational site worldwide
Bridgewater, New Jersey, United States, 08807
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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