Avalglucosidase Alfa Pregnancy Study
Recruiting
Observational Study
Pompe Disease
Pregnancy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Female
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
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 a…
Trial Locations
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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 pregna…
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
CONTACT