NCT06449651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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 42
- 主要终点
- Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
- •Has a history of greater than or equal to (>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (<) 150×10^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records
- •Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
- •Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
- •For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit
排除标准
- •Currently pregnant with multiple gestations (twins or more)
- •History of severe preeclampsia 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 Investigator Brochure (IB))
- •Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
研究组 & 干预措施
Placebo
Placebo Comparator
Maternal participants will receive placebo IV.
干预措施: Placebo (Drug)
Nipocalimab
Active Comparator
Maternal participants will receive nipocalimab Intravenously (IV).
干预措施: Nipocalimab (Drug)
结局指标
主要结局
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
时间窗: Up to 1 week post birth
Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count \<30\*10\^9/L will be reported.
次要结局
- Neonate/Fetus With Adjudicated Bleeding(Up to 1 Week post birth)
- Platelet Count at Birth in a Neonate(At birth)
- Neonate/Fetus with Outcome of Death(Up to 1 Week post birth)
- Platelet Count at Birth <10×10^9/L in a Neonate(At birth)
- Number of Platelet Transfusion(s) in Neonate/Fetus(Up to 1 Week post birth)
- Platelet Count at Birth <30×10^9/ L In a Neonate(At birth)
- Platelet Count at Birth <50×10^9/L In a Neonate(At birth)
- Platelet Count at Birth <150×10^9/L In a Neonate(At birth)
- Nadir Platelet Count of a Neonate Over the First Week Post Birth(Upto 1 Week post birth)
- Neonate/Fetus Requiring Platelet Transfusion(s)(Up to 1 Week post birth)
- Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus(Up to 1 Week post birth)
- Neonate/Fetus With Adjudicated Severe Bleeding(Up to 1 week post birth)
- Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia(Up to 1 Week post birth)
- Maternal Participants With Treatment-Emergent Adverse Event (TEAE)(From randomization up to 24 weeks postpartum)
- Maternal Participants With Serious Adverse Event (SAE)(From randomization up to 24 weeks postpartum)
- Maternal Participants With Adverse Event of Special Interest (AESI)(From randomization up to 24 weeks postpartum)
- Maternal Participants with TEAE Leading to Discontinuation of Study Intervention(Up to Week 104)
- Neonate/Infant with TEAE(Up to Week 104)
- Neonate/Infant with SAE(Up to Week 104)
- Neonate/Infant with AESI(Up to Week 104)
- Fetus/Neonate With TEAE of Bleeding(Up to Week 104)
- Neonate With TEAE of Infection(Up to Week 104)
- Infant Development as Measured by Bayley Scales at Week 52 and Week 104(At Week 52 and 104)
- Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum(Up to Week 24)
研究者
研究点 (42)
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