A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Biogen
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Major Congenital Malformations (MCMs)
研究概览
简要总结
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will have taken BIIB141 at any time during pregnancy and/or while breastfeeding or pumping up through the first year after delivery. Participants can join this study on their own or they may be enrolled by their regular doctors. This study is also known as the "SKYCLARYS (Omaveloxolone) Pregnancy and Lactation Surveillance Program."
The main objective of this study is to learn more about how BIIB141 may affect pregnancy, as well as any effects on the health of the mother and of the baby during its first year of life.
The main question researchers want to answer in this study is:
· Does taking BIIB141 during pregnancy or breastfeeding lead to any major birth defects?
Researchers will also learn more about:
- Does taking BIIB141 during pregnancy or breastfeeding lead to any minor birth defects?
- Does taking BIIB141 during pregnancy or breastfeeding affect the following:
- Gestational diabetes, a disease that can happen during pregnancy that affects how your body uses sugar
- Pre-eclampsia, a pregnancy-related high blood pressure disease
- Unborn baby being small for its expected age (usually in weeks)
- Loss of an unborn baby
- Live birth
- Premature birth
- Loss of a newborn
- Growth or developmental delays in the baby
- Serious illness in the baby resulting in hospitalization
- Serious infections in the baby, or ones in babies with a weakened immune system
This study will be done as follows:
- Participants will join the study after signing an informed consent form, also known as an ICF.
- During the study, health information from the participants' regular visits to their doctor will be collected based on whether participant joined the study while pregnant or after the baby is born.
- Each participant will be in the study for up to 1 year after the birth of their child, unless they decide to leave early. Overall, this study is expected to last at least 10 years.
详细描述
The objective is to conduct a worldwide descriptive study to collect prospective and retrospective data in women exposed to omaveloxolone during pregnancy and/or lactation to assess risk associated with pregnancy, the maternal complications, and adverse effects on the developing fetus, neonate, and infant (through at least the first year of life) in the post-marketing setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Exposure to omaveloxolone for FA at any time during pregnancy (from 12 days prior to conception to pregnancy outcome) and/or at any time during lactation (up to 1 year of infant age or weaning, whichever comes first).
排除标准
- •- Not having exposure to omaveloxolone for FA.
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Omaveloxolone
Participants with FA who were exposed to omaveloxolone at any time during pregnancy (from 12 days prior to conception through the end of pregnancy outcome), and/or at any time during lactation (up to 1 year of infant age or weaning, whichever comes first).
干预措施: Omaveloxolone (Drug)
结局指标
主要结局
Number of Major Congenital Malformations (MCMs)
时间窗: Up to 10 years
A MCM is defined as 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 participant; and typically requires medical intervention.
次要结局
- Number of Minor Congenital Malformations(Up to 10 years)
- Number of Participants With Gestational Diabetes(Up to 9 months)
- Number of Participants With Pre-eclampsia(Up to 9 months)
- Number of Fetal Loss(Up to 9 months)
- Number of Spontaneous Abortions(Up to 9 months)
- Number of Stillbirths(Up to 9 months)
- Number of Elective or Therapeutic Abortion(Up to 9 months)
- Number of Live Births(Up to 9 months)
- Number of Preterm Births(Up to 9 months)
- Number of Small for Gestational Age (SGA)(Up to 9 months)
- Number of Neonatal Deaths(Within 28 days postdelivery)
- Number of Infant Deaths(Up to approximately 1 year)
- Number of Infants with Abnormal Postnatal Growth and Development(Up to approximately 1 year)
- Number of Infant Hospitalization due to Serious Illness(Up to 1 year)
- Number of Infant Serious or Opportunistic Infections(Up to 1 year)