WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,329
- 试验地点
- 2
- 主要终点
- Major congenital malformation
研究概览
简要总结
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
详细描述
The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable. The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are routinely documented in patients' medical records during the course of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry. The design of this pregnancy registry follows current FDA guidance for designing and implementing pregnancy exposure registries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman of any age
- •Consent to participate
- •Authorization for her HCP(s) to provide data to the registry
- •For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy)
- •For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy
- •Exclusion Criterion:
- •Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)
排除标准
- 未提供
研究组 & 干预措施
Pitolisant-exposed participants with narcolepsy
Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
干预措施: Pitolisant (Drug)
Comparator-exposed participants with narcolepsy
Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to comparator products at any time during pregnancy
干预措施: Comparator Products (Drug)
Pitolisant-exposed participants without narcolepsy
Pregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy
干预措施: Pitolisant (Drug)
Comparator-exposed participants without narcolepsy
Pregnant women without a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to a comparator product at any time during pregnancy
干预措施: Comparator Products (Drug)
结局指标
主要结局
Major congenital malformation
时间窗: Enrollment through the infant's first year of life
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.
次要结局
- Eclampsia(Enrollment through pregnancy outcome)
- Preterm birth(Enrollment through the infant's first year of life)
- Pre-eclampsia(Enrollment through pregnancy outcome)
- Minor congenital malformation(Enrollment through the infant's first year of life)
- Spontaneous abortion(Enrollment through pregnancy outcome)
- Small for gestational age(Enrollment through the infant's first year of life)
- Elective termination(Enrollment through pregnancy outcome)
- Postnatal growth deficiency(Enrollment through the infant's first year of life)
- Stillbirth(Enrollment through pregnancy outcome)
- Infant development deficiency(Enrollment through the infant's first year of life)