NCT01139203Unknown不适用
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- serological markers of HBV
研究概览
简要总结
Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients into the transplant waiting list with HBV-related liver disease.
- •HBsAg-positive.
- •serum HBV-DNA negative.
- •no HCV, HDV and HIV co-infection.
- •without renal dysfunction.
- •No lamivudine, adefovir and entecavir drug allergy history.
- •no HBV-YMDD mutation for patients who have a long-term use of lamivudine.
排除标准
- •patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
- •HBsAg-negative.
- •serum HBV-DNA positive.
- •HCV, HDV and HIV co-infection.
- •patients with severe renal dysfunction or failure.
- •lamivudine, adefovir and entecavir drug allergy history.
- •HBV-YMDD mutation for patients who have a long-term use of lamivudine.
研究组 & 干预措施
lamivudine
Active Comparator
干预措施: lamivudine adefovir entecavir HBIG (Drug)
lamivudine and adefovir
Active Comparator
干预措施: lamivudine adefovir entecavir HBIG (Drug)
entecavir
Active Comparator
干预措施: lamivudine adefovir entecavir HBIG (Drug)
结局指标
主要结局
serological markers of HBV
时间窗: every three month after liver transplantation
Serological markers of HBV include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA.
次要结局
未报告次要终点
研究者
研究点 (1)
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