Safety study of avalglucosidase alfa during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect data on the safety of avalglucosidase alfa in women and their offspring during pregnancy and lactation. It will assess potential risks and complications associated with the drug for both mothers and their developing children. The study will follow participants for at least 10 years, evaluating outcomes in exposed infants, including their growth and development through the first year of life. Data will be gathered retrospectively and prospectively to provide a comprehensive understanding of the drug's effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Investigational site worldwide
  Bridgewater, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.