avalglucosidase alfa-NGPT (GZ402666): exposed via pregnancy and lactation
Study 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.
Eligibility
Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Maternal complications — through study completion, an average of 10 years Prevalence of pregnancy/labor/delivery/postpartum maternal complications
Pregnancy outcome — through study completion, an average of 10 years Prevalence of live births, spontaneous abortions (\<20 weeks of gestation), elective terminations, ectopic pregnancies, early fetal deaths (20 to 27 weeks of gestation), late fetal deaths (≥28 weeks of gestation), stillbirths and maternal deaths
Infant outcome — through study completion, an average of 10 years Number of occurrences of major congenital anomalies, neonatal deaths, development delays (growth, motor, neurologic, behavioral) through first year of life.
Major congenital anomalies defined using the US Centers for Disease Control and Prevention (CDC) and growth and development assessments using CDC's Developmental Milestones 2021.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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