NCT01513850已完成3 期
A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- HBV(HBsAg) recurrence
研究概览
简要总结
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
详细描述
A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg Positive candidate for HBV-related liver transplant
- •Primary, single organ recipients
- •written informed consent
排除标准
- •acute renal failure, Serum creatinin >1.5*ULN
- •severe cardiac disease or other significant disease
- •HAV, HCV or HIV positive
- •Immunoglobulin A deficiency.
- •History of hypersensitivity to Human Immunoglobulin.
- •History of cancer within 5 years. (without HCC)
- •History of alcohol or/and drug abuse.
- •History organ transplantation.
- •Within 30 days, participation in another clinical trial and use of an investigational product.
- •Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.
研究组 & 干预措施
Hepabulin IV
Experimental
干预措施: Hepabulin IV (Drug)
结局指标
主要结局
HBV(HBsAg) recurrence
时间窗: 52 weeks
次要结局
- viral Marker of HBV(52 weeks)
- Time to recurrence(52 weeks)
- Survival(52 weeks)
研究者
研究点 (1)
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