Avalglucosidase Alfa Pregnancy Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorSanofi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
avalglucosidase alfa-NGPT (GZ402666) IV
Biological/Vaccineintravenous infusion
avalglucosidase alfa-NGPT (GZ402666)
Biological/Vaccineexposed via pregnancy and lactation
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Pregnant women exposed to avalglucosidase alfa1 intervention
Group B: Infants born to mother/father exposed to avalglucosidase alfa1 intervention
Trial outcomes
Primary outcomes
1
Maternal complications
Prevalence of pregnancy/labor/delivery/postpartum maternal complications
Time frame
through study completion, an average of 10 years2
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
Time frame
through study completion, an average of 10 years3
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.
Time frame
through study completion, an average of 10 years Source ClinicalTrials.gov