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Avalglucosidase Alfa Pregnancy Study

Recruitingn/aAges any - anyFemaleSanofi
NCT05734521 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • avalglucosidase alfa-NGPT (GZ402666) IV
  • avalglucosidase alfa-NGPT (GZ402666)
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Where

1 site
Investigational site worldwide
Bridgewater, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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