Avalglucosidase Alfa Pregnancy Study

Safety of Investigational Medication During Pregnancy and Lactation

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.

This study investigates the safety of an investigational medication when used by women during pregnancy and lactation. The purpose is to collect data on the effects of the medication on pregnancy outcomes, maternal health, and the developing child. Outcomes in infants exposed to the medication will be assessed, including their growth and development through at least the first year of life.

Participants will have their data collected to observe any potential complications or adverse effects associated with the investigational medication. This study will gather information both retrospectively and prospectively, meaning it will include past and future data collection. The study aims to provide a comprehensive understanding of the medication's impact over approximately 10 years.

  • Who can participate: Women who were exposed to the investigational medication during pregnancy or lactation and have submitted a safety report, or those who have consented to join the Pompe Pregnancy Sub-registry, can participate. There are no exclusion criteria for this study.
  • Study details: Participants will have their health and the health of their infants monitored through data collection. This involves providing information about their exposure to the investigational medication and any related health outcomes.
  • Study timelines: The study will last 10 years.
Updated on 14 Jan 2026. Study ID: NCT05734521

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