Avalglucosidase Alfa Pregnancy Study

Recruiting now

Conditions studied: Pompe Disease, Pregnancy

In brief

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.

Key facts

Study ID

NCT05734521

Run by

Sanofi

People needed

100

Starts

2022-10-26

Expected to finish

2032-10-31

Last updated by the study team

2026-01-16

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational site worldwide — Bridgewater, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.