Avalglucosidase Alfa Pregnancy Study

Study on 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/or lactation. The purpose is to assess any risks associated with the investigational medication on pregnancy, as well as potential complications and adverse effects in the developing fetus, neonate, and infant.

Participants will have their data collected over approximately 10 years. The study will assess outcomes in infants, including growth and development, through at least the first year of life. The study uses both retrospective and prospective approaches to gather this information.

  • Who can participate: Women exposed to the investigational medication during pregnancy and/or lactation, who have submitted a safety report or consented to the sub-registry, can participate.
  • Study details: Participants will provide data on their health and their offspring's health for 10 years, including assessments of infant growth in the first year.
  • Study timelines: The study will last approximately 10 years.
Updated on 15 Jul 2024. Study ID: NCT05734521

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