Avalglucosidase Alfa Pregnancy Study

Investigating Safety of Investigational Medication in 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 in women and their offspring during pregnancy and lactation. It focuses on understanding potential risks associated with exposure to the medication during these critical periods.

The study evaluates outcomes such as growth and development in infants exposed to the investigational medication. This study evaluates comprehensive safety data over a long-term period.

  • Who can participate: Women exposed to the investigational medication during pregnancy or lactation who have submitted a safety report or provided informed consent can participate.
  • Study details: Participants will provide data on their experiences and the health of their offspring. This includes monitoring growth and development outcomes.
  • Study timelines: The study will last 10 years.
Updated on 14 Jan 2026. Study ID: NCT05734521

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