NCT06333652招募中2 期
Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Alternative Complement Pathway Biomarkers at time of delivery
研究概览
简要总结
The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals with < 34 0/7 weeks of gestation.
- •Individuals with severe preeclampsia or HELLP features.
排除标准
- •Pregnant female patients presenting with disseminated intravascular coagulopathy (DIC).
- •Individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to Ravulizumab, inability or unwillingness to sign informed consent.
研究组 & 干预措施
Revulizumab Treatment
Experimental
Subjects will receive an single-dose infusion of Ravulizumab.
干预措施: Ravulizumab (Drug)
结局指标
主要结局
Alternative Complement Pathway Biomarkers at time of delivery
时间窗: Baseline
Concentration in serum of biomarkers: sMAC, Bb, and C5 at time of delivery
次要结局
- Hospitalization length in the postpartum period(Approximately 3-5 days, it may vary)
- Meningococcal infection after use of ravulizumab(72 hours up to 3 weeks after Ravulizumab infusion)
- Clinical biomarkers of severe features of preeclampsia and HELLP syndrome(72 hours after Ravulizumab infusion)
- Pregnancy duration(Approximately 40 weeks)
研究者
Maria Lourdes Gonzalez Suarez
Principal Investigator
Mayo Clinic
研究点 (2)
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