Avalglucosidase Alfa Pregnancy Study

Purpose

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.

Conditions

  • Pompe Disease
  • Pregnancy

Eligibility

Eligible Ages
All ages
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Pregnant women exposed to avalglucosidase alfa Pregnant women with a confirmed diagnosis of Pompe disease and avalglucosidase alfa exposure during the pregnancy and/or lactation
  • Biological: avalglucosidase alfa-NGPT (GZ402666) IV
    intravenous infusion
    Other names:
    • NEXVIAZYME
Infants born to mother/father exposed to avalglucosidase alfa Infants born to mother/father with a confirmed diagnosis of Pompe disease and exposed to avalglucosidase alfa
  • Biological: avalglucosidase alfa-NGPT (GZ402666)
    exposed via pregnancy and lactation
    Other names:
    • NEXVIAZYME

Recruiting Locations

Investigational site worldwide
Bridgewater, New Jersey 08807

More Details

NCT ID
NCT05734521
Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com

Detailed Description

Study Design Time Perspective: Retrospective and Prospective

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center