NCT01046799已完成3 期
Prevention of HBV Reinfection After Liver Transplantation Using Entecavir Monotherapy After Short-term HBIg Administration: A Pilot Study
HepNet Study House, German Liverfoundation3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
研究概览
简要总结
The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver transplantation for hepatitis B induced endstage liver disease
- •absence of coinfection with HIV and HCV
- •female and male patients >= 18 years of age
排除标准
- •any evidence of other causes for endstage liver disease
- •patients that do not fulfill the criteria for liver transplantation
研究组 & 干预措施
Entecavir
Experimental
干预措施: Entecavir (Drug)
结局指标
主要结局
prevention of hepatitis B virus reinfection one year after liver transplantation with entecavir monotherapy
时间窗: one year
次要结局
- hepatitis Bs antigen negativity can be maintained by entecavir in the second year after HBV induced liver transplantation(two years)
研究者
研究点 (3)
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