ACTRN12614001224617进行中（未招募）4 期
A randomized clinical trial to study whether telbivudine can decrease the hepatitis B virus reactivation in patients with hepatocellular carcinoma and HBV-DNA < 2000 IU/ml after liver resection.
ZHOU Wei-ping0 个研究点目标入组 200 人开始时间: 2014年11月21日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1) Age 18 to 70 years;
- •2) Positive test for Hepatitis B surface antigen (HBsAg)
- •3) Serum hepatitis B virus-deoxyribonucleic acid (HBV-DNA) level lower than 2000IU/ml;
- •4) Serum ALT levels are below the upper limit of normal (ULN);
- •5) Resectable tumour with Barcelona Clinic Liver Cancer (BCLA) stage 0 or A;
- •6)Good liver function with Child-Pugh Class A, with no history of encephalopathy, ascites refractory to diuretics, esophago-gastricvaricesor variceal bleeding;
- •7) Good kidney function (a serum creatinine level < 133 umol/L and creatinine clearance >60 ml/min);
- •8) The preoperative diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
排除标准
- •1)Positive tests for antibody to hepatitis C virus (HCV-Ab) or human immunodeficiency virus;
- •2)extrahepatic metastasis;
- •3)radiologic evidence of invasion into the major portal/hepatic venous branches;
- •4)previous treatment of HCC;
- •5)previous history of antiviral therapy;
- •6)previous history of cancer and chemotherapy
- •7)previous history of immunosuppressive therapy
研究者
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