CTIS2023-504307-88-00进行中（未招募）1 期
Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies - 80202135FNAIT3001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Female, =18 years of age at the time of informed consent, Pregnant and an estimated GA (based on ultrasound dating) between Week 13 to 16 at randomization, Has a history of =1 prior pregnancy with FNAIT (including neonatal platelet count <150×109/L), with none of them affected by fetal/neonatal ICH or severe hemorrhage based on medical records, Current pregnancy with presence of maternal anti-HPA-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal DNA in maternal blood, Health status considered stable by the investigator on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening
排除标准
- •Currently pregnant with multiple gestations (twins or more), History of severe preeclampsia in a previous pregnancy, History of severe FGR (EFW <3rd percentile) in a previous pregnancy, History of myocardial infarction, unstable ischemic heart disease, or stroke, Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the IB)
研究者
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