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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pregnancy outcome
研究概览
简要总结
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.
详细描述
Study Design Time Perspective: Retrospective and Prospective
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: avalglucosidase alfa-NGPT (GZ402666) IV (Biological)
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
干预措施: avalglucosidase alfa-NGPT (GZ402666) (Biological)
结局指标
主要结局
Pregnancy outcome
时间窗: through study completion, an average of 10 years
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
Infant outcome
时间窗: through study completion, an average of 10 years
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.
Maternal complications
时间窗: through study completion, an average of 10 years
Prevalence of pregnancy/labor/delivery/postpartum maternal complications
次要结局
未报告次要终点