Avalglucosidase Alfa Pregnancy Study
Study on Safety of Investigational Medication During Pregnancy and Lactation
Study Overview
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.
Study Details
Study Design Time Perspective: Retrospective and Prospective
Eligibility Criteria
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.
This study investigates the safety of an investigational medication when used by women during pregnancy and breastfeeding. It aims to understand the potential risks to both the mother and the developing baby. The study will look at any complications during pregnancy and any effects on the baby, including growth and development during the first year of life.
Participants will be asked to provide information about their health and their baby's health. This includes any medical issues that arise during pregnancy or after birth. The study will collect data over a period of 10 years to ensure comprehensive safety information.
- Who can participate: Women who have been exposed to the investigational medication during pregnancy or breastfeeding and have submitted an Individual Case Safety Report (ICSR), or those who have given consent to join the study. There are no age restrictions.
- Study Details: Participants will provide health information about themselves and their babies. The study will track the baby's growth and development for at least the first year. Data collection will continue for approximately 10 years.
- Study Timelines: The study will last 10 years.
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