Avalglucosidase Alfa Pregnancy Study
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 →
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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