NCT05734521Recruiting

Avalglucosidase Alfa Pregnancy Study

Sanofi

Start Date

10/26/2022

Completion Date

10/31/2032

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

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation for whom an Individual Case Safety Report (ICSR) has been submitted to the Sanofi Global Pharmacovigilance (PV) department, and/or, * Women exposed to avalglucosidase alfa during pregnancy and/or lactation who have provided informed consent to enroll in the Pompe Pregnancy Sub-registry. Exclusion Criteria: There are no exclusion criteria in this study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Interventions

BIOLOGICAL

avalglucosidase alfa-NGPT (GZ402666) IV

BIOLOGICAL

avalglucosidase alfa-NGPT (GZ402666)

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Conditions

Pompe DiseasePregnancy

Locations

Investigational site worldwide

Bridgewater, New Jersey 08807

United States