clinical trial · NCT05734521

Avalglucosidase Alfa Pregnancy Study

$SNY →·—·recruiting·n = 100

Pompe DiseasePregnancyavalglucosidase alfa-NGPT (GZ402666) IVavalglucosidase alfa-NGPT (GZ402666)

brief 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.

started

Oct 26, 2022

primary completion

Oct 31, 2032

completion

Oct 31, 2032

last updated

Jan 16, 2026

detailed description

Study Design Time Perspective: Retrospective and Prospective

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

full record on clinicaltrials.gov ↗

sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol