Avalglucosidase Alfa Pregnancy Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Study Design Time Perspective: Retrospective and Prospective ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05734521
Study type	Observational
Source	Sanofi
Contact	Trial Transparency email recommended (Toll free for US & Canada)
Phone	800-633-1610
Email	Contact-US@sanofi.com
Status	Recruiting
Phase
Start date	October 26, 2022
Completion date	October 2032

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