Avalglucosidase Alfa Pregnancy Study

Investigating 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.

Updated on 21 Feb 2023. Study ID: NCT05734521

This study investigates the safety of an investigational medication when used during pregnancy and breastfeeding. The purpose is to understand the risks associated with the medication on pregnancy outcomes, maternal health, and the development of the baby. The study will collect data on any complications or side effects that may occur in the mother or child due to exposure to the medication during these critical periods.

Participants in the study will have data collected about them and their children. This includes monitoring the growth and development of infants who were exposed to the investigational medication, up to at least the first year of life. The study will gather information over a long period to ensure a comprehensive understanding of any potential risks.

  • Who can participate: Women who have used the investigational medication during pregnancy or breastfeeding can participate. They must have been exposed to the investigational medication during pregnancy and/or lactation and have a safety report submitted to the Sanofi Global Pharmacovigilance department or consented to join the Pompe Pregnancy Sub-registry.
  • Study details: Participants will have their health and the health of their children monitored and recorded. The study focuses on collecting safety data to assess any health impacts from the investigational medication.
  • Study Timelines: The study will last approximately 10 years.

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