NCT05734521Recruiting
Avalglucosidase Alfa Pregnancy Study
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
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 3 Feb 2023
- Start date
- 26 Oct 2022
- Primary completion date
- 31 Oct 2032
- Lead sponsor
- Sanofi
- Diseases
- Pompe disease
- NCT number
- NCT05734521
What you commit to
- Study type: Observational
- Planned participants: 100
- From 26 Oct 2022 to the primary completion date, 31 Oct 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational site worldwide Coordinator of this site? Confirm its status | Bridgewater | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.