NCT01886248Unknown2 期
Antithrombin-III for Patients With Hepatic Veno-occlusive Diseases Following Hematopoietic Stem Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- AT-III level before 5th dose of AT-III
研究概览
简要总结
To evaluate efficacy and safety of AT-III treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. The following criteria will be used.
- •Two of the following
- •Serum total bilirubin > 2.0 mg/dL
- •Hepatomegaly or right upper quadrant pain of liver origin
- •Unexplained weight gain of>2% over baseline because of fluid accumulation
- •Patients with pathologic diagnosis.
- •Patients with informed consent
排除标准
- •Pregnant or nursing women.
- •Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- •Psychiatric disorder that would preclude compliance.
- •Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- •History of anaphylactic reaction to the study drug
研究组 & 干预措施
Antithrombin-III Human 500IU
Experimental
Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU
Units required (IU)/kg = 50 + [(desired-baseline AT-III level) x weight (kg) / 1.4]
干预措施: Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU (Drug)
结局指标
主要结局
AT-III level before 5th dose of AT-III
时间窗: up to 14 days
次要结局
- AT-III level before 9th dose(up to 14 days)
研究者
研究点 (1)
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