NCT03805581已完成2 期
A Phase II Study to Determine the Safety of Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients with grade III/IV allergic reaction to defibrotide
研究概览
简要总结
This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).
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
- 2 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCD-associated ACS with the presence of any two or more of the following signs not explained by other etiologies: Fever, Chest pain, Cough, Dyspnea, Tachypnea for age, Pulmonary infiltrate on CXR and/or Chest CT scan, Decreased O2 saturation with or without oxygen supplement;
- •Age 2 to 40 years of age;
- •Homozygous Hemoglobin S Disease, Hemoglobin SC Disease or Hemoglobin S 0/+ thalassemia;
- •Informed consent/assent;
- •Consent of patient/parent within ≤72 hours after inpatient admission for SCD-associated ACS.
- •Females of childbearing age will have a negative pregnancy test.
排除标准
- •Current Grade III or IV hemorrhage;
- •Previous hypersensitivity reaction to defibrotide;
- •Current systemic anti-coagulant therapy and/or fibrinolytic therapy;
- •Consent of patient/parent greater than 72 hours of inpatient admission for SCD-associated ACS;
- •No signed informed consent
研究组 & 干预措施
Interventional
Experimental
Defibrotide 6.25 mg/kg IV q6h
干预措施: Defibrotide (Drug)
结局指标
主要结局
Number of patients with grade III/IV allergic reaction to defibrotide
时间窗: 30 days
All patients will be monitored for allergic reaction probably or definitely related to defibrotide administration.
Number of patients with grade III/IV hemorrhage
时间窗: 30 days
All patients will be monitored for hemorrhage probably or definitely related to defibrotide.
次要结局
- Number of patients with improvement in clinical signs of Acute Chest Syndrome(30 days)
研究者
研究点 (1)
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