RecruitingNCT05734521

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

Sponsor

Sanofi

Enrollment

100 participants

Start Date

Oct 26, 2022

Study Type

OBSERVATIONAL

Conditions

Pregnancy Pompe Disease

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.

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called avalglucosidase alfa-NGPT (GZ402666) and a biological treatment called avalglucosidase alfa-NGPT (GZ402666) IV for people with pompe disease and pregnancy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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