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Summary
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.
Official title: A Descriptive Safety Study Based on Data Collected From Women and Their Offspring Exposed to Nexviazyme/Nexviadyme (Avalglucosidase Alfa-ngpt/Avalglucosidase Alfa) During Pregnancy and/or Lactation in the Postmarketing Setting
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2022-10-26
Completion Date
2032-10-31
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
avalglucosidase alfa-NGPT (GZ402666) IV
intravenous infusion
avalglucosidase alfa-NGPT (GZ402666)
exposed via pregnancy and lactation
Locations (1)
Investigational site worldwide
Bridgewater, New Jersey, United States