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Recruiting NCT05734521

Avalglucosidase Alfa Pregnancy Study

— Observational Pompe Disease Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: avalglucosidase alfa-NGPT (GZ402666) IV, avalglucosidase alfa-NGPT (GZ402666).
Who it may be relevant to
Registry conditions: Pompe Disease, Pregnancy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

Study Design Time Perspective: Retrospective and Prospective

Interventions

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

Primary outcome measures

  • Maternal complications [Time frame: through study completion, an average of 10 years]
  • Pregnancy outcome [Time frame: through study completion, an average of 10 years]
  • Infant outcome [Time frame: through study completion, an average of 10 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Investigational site worldwide — Bridgewater

Identifiers

NCT: NCT05734521 · OBS17641

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗