NCT03008616终止2 期
A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects With Severe Preeclampsia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 36
- 主要终点
- Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
研究概览
简要总结
This study evaluates the use of AMAG-423 (Digoxin Immune Fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fetal gestational age 23 0/7 to 31 6/7 weeks
- •Treated with expectant management
- •Meets modified ACOG criteria for severe preeclampsia
- •Willing and able to provide written, informed consent
排除标准
- •Decision to deliver within 24 hours has been made
- •Weight > 150 kg
- •Eclampsia
- •Significant antecedent obstetrical problems
- •Clinically significant fetal anomaly or chromosomal abnormalities
- •Chronic renal disease
- •Active hepatic disease, antiphospholipid antibody syndrome, or lupus
- •Unstable medical or psychiatric disorder
- •Need for use of digitalis like products
- •History of anaphylactic allergic reactions
- •Prior use of antibodies/fab fragments from sheep
- •Serum creatinine ≥ 2.0 mg/dL
- •Platelet count < 50,000
- •Pulmonary edema
- •Estimated fetal weight < 5th percentile
研究组 & 干预措施
AMAG-423 (digoxin immune fab)
Active Comparator
AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
干预措施: AMAG-423 (digoxin immune fab) (Biological)
Placebo
Placebo Comparator
Normal saline, 30 minute IV infusion, every 6 hours x 4 days
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
时间窗: 36 weeks corrected gestational age
Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age
次要结局
- Change from baseline in serum creatinine(From treatment initiation to 24 hours post first dose)
- Incidence of pulmonary edema(From treatment initiation until completion of treatment phase (up to 4 days))
- Proportion of mothers with modified early obstetric warning score >= 3 at 24 hours post first dose(24 hours post first dose)
- Delivery latency(From treatment initiation until delivery)
- Anti-hypertensive use during treatment(From treatment initiation until completion of treatment phase (up to 4 days))
研究者
研究点 (36)
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