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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
Who can join
All ages · Women
Full eligibility criteria
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.
About the study
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.
What is being tested
- avalglucosidase alfa-NGPT (GZ402666) IV (biological)
- avalglucosidase alfa-NGPT (GZ402666) (biological)
Sponsor: Sanofi · Participants: 100 · Started: Oct 26, 2022
Contact the study team
- Trial Transparency email recommended (Toll free for US & Canada) · Phone: 800-633-1610
Official record on ClinicalTrials.gov — NCT05734521
Locations in the U.S.
| New Jersey | Investigational site worldwide, Bridgewater |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.