Avalglucosidase Alfa Pregnancy Study
Brief description of 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.
Detailed description of study
Study Design Time Perspective: Retrospective and Prospective
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pompe Disease, Pregnancy
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Gender: Female
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.
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