Avalglucosidase Alfa Pregnancy Study

Effects of Investigational Medication During Pregnancy and Breastfeeding

Recruiting
Female
Phase N/A
100 participants needed
1 Location

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
  • 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.

Updated on 15 Jul 2024. Study ID: NCT05734521

This study investigates the safety of an investigational medication taken by women during pregnancy and breastfeeding. The study aims to understand any risks this medication may have on pregnancy, as well as any complications or side effects it may cause in the developing baby, newborn, and infant. The study will look at the growth and development of babies who were exposed to the medication during their first year of life.

Participants in the study will have their data collected over a period of about 10 years. This will help researchers gather information on the long-term effects of the medication. The study uses both retrospective and prospective methods, meaning it looks at past data and continues to collect new data moving forward.

  • Who can participate: Women and their children exposed to an investigational medication during pregnancy or breastfeeding can participate. Participants must have submitted a safety report or provided consent.
  • Study details: Participants will have their medical data collected and analyzed for up to 10 years. This involves tracking the growth and development of infants exposed to the investigational medication.

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