Safety study of avalglucosidase alfa during pregnancy
A Descriptive Safety Study Based on Data Collected From Women and Their Offspring Exposed to Nexviazyme/Nexviadyme (Avalglucosidase Alfa-ngpt/Avalglucosidase Alfa) During Pregnancy and/or Lactation in the Postmarketing Setting
This study is looking at how safe the drug avalglucosidase alfa is for pregnant women and their babies during pregnancy and breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | Female |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 1 site (Bridgewater, New Jersey) |
| Trial ID | NCT05734521 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women who have been exposed to avalglucosidase alfa during pregnancy or lactation and have consented to participate.
Not a fit: Patients who have not been exposed to avalglucosidase alfa during pregnancy or lactation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety information for pregnant women with Pompe disease using avalglucosidase alfa.
How similar studies have performed: While this study focuses on a specific population, similar observational studies have provided valuable safety data for other medications during pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bridgewater, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.