Avalglucosidase Alfa Pregnancy Study

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734521
• Other study ID #: OBS17641
• Status: Recruiting
• Start date: October 26, 2022
• Est. completion date: October 2032

Study information

• Verified date: February 2023
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Study Design Time Perspective: Retrospective and Prospective

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2032
• Est. primary completion date: October 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Glycogen Storage Disease Type II
• Pompe Disease
• Pregnancy

Intervention

Biological:
• avalglucosidase alfa-NGPT (GZ402666) IV
intravenous infusion
• avalglucosidase alfa-NGPT (GZ402666)
exposed via pregnancy and lactation

Locations

Country	Name	City	State
United States	Investigational site worldwide	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal complications	Prevalence of pregnancy/labor/delivery/postpartum maternal complications	through study completion, an average of 10 years
Primary	Pregnancy outcome	Prevalence of live births, spontaneous abortions (<20 weeks of gestation), elective terminations, ectopic pregnancies, early fetal deaths (20 to 27 weeks of gestation), late fetal deaths (=28 weeks of gestation), stillbirths and maternal deaths	through study completion, an average of 10 years
Primary	Infant outcome	Number of occurrences of major congenital anomalies, neonatal deaths, development delays (growth, motor, neurologic, behavioral) through first year of life.; Major congenital anomalies defined using the US Centers for Disease Control and Prevention (CDC) and growth and development assessments using CDC's Developmental Milestones 2021.	through study completion, an average of 10 years