2023-504307-88-00招募中3 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 17
- 主要终点
- Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth <30×10⁹/l in a fetus/neonate.
研究概览
简要总结
To evaluate the superiority of nipocalimab compared with placebo in reducing the risk of severe FNAIT
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 (or the legal age of consent if above 18 years of agein local region) to 45 years at the time of informed consent.
- •Pregnant and an estimated GA (based on ultrasound dating) from Week 13^0/7 to 18^6/7 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 (birth weight <3rd percentile for GA) 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)
结局指标
主要结局
Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth <30×10⁹/l in a fetus/neonate.
Adverse outcome of death or adjudicated severe bleeding in utero up to the first week post birth, or platelet count at birth <30×10⁹/l in a fetus/neonate.
次要结局
- Platelet count at birth in a neonate
- Adjudicated bleeding in utero up to the first week post birth in a fetus/neonate
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (17)
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