NCT02125071已完成不适用
An Exploratory Clinical Trial to Evaluate the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation
Dong-Gu Kim1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- anti-HBs titer
研究概览
简要总结
An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≤18 years old
- •Patients who understand the informed consent form and signed the form voluntarily
- •Patients who underwent liver transplantation due to HBV related disease and will be treated for prevention of hepatitis B relapse after liver transplantation
排除标准
- •Multi-organ recipient or reimplantation
- •IgA Deficiency
- •Serious nephropathy
- •Serious cardiovascular system failure within 6 months
- •Ischemic or hemolytic anemia
- •Condition of immunosuppression and immunodeficiency
- •Hypersensitivity or allergic to blood products
- •HIV or HCV positive
- •Participation to other clinical trial within 3 months
- •Pregnancy or breast feeding
- •Those who the investigator determines inappropriate to participate
结局指标
主要结局
anti-HBs titer
时间窗: up to 6 months
The anti-HBs titer is measured on the day of LT, day 1, week 1, week 4, week 12 and week 24, to determine the pharmacokinetic characteristic of Hepabig I.V. injection
次要结局
未报告次要终点
研究者
Dong-Gu Kim
MD, Phd
Seoul St. Mary's Hospital
研究点 (1)
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