NCT05734521

Avalglucosidase Alfa Pregnancy Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Study Design Time Perspective: Retrospective and Prospective

Conditions

• Pompe Disease
• Pregnancy

Interventions

Type	Name	Description
BIOLOGICAL	avalglucosidase alfa-NGPT (GZ402666) IV	intravenous infusion
BIOLOGICAL	avalglucosidase alfa-NGPT (GZ402666)	exposed via pregnancy and lactation

Timeline

• Start date: 2022-10-26
• Primary completion: 2032-10-31
• Completion: 2032-10-31
• First posted: 2023-02-21
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study