MedTrace Logo

Avalglucosidase Alfa Pregnancy Study

NCT05734521 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

  • Pompe Disease
  • Pregnancy

Interventions

BIOLOGICAL

avalglucosidase alfa-NGPT (GZ402666) IV

intravenous infusion

BIOLOGICAL

avalglucosidase alfa-NGPT (GZ402666)

exposed via pregnancy and lactation

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2032-10-31
Completion
2032-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734521 on ClinicalTrials.gov