JPRN-UMIN000005992已完成未知
Efficacy of entecavir as an adjuvant therapy for hepatocellular carcinoma derived from HBV infection: a prospective trial - ETV-HCC
Tokyo University Hospital0 个研究点目标入组 40 人开始时间: 2011年7月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)the pregnancy and the nursing. (2)Women with childbearing age who is impossible to undergo appropriate contraception. (3) The women who are positive by an examination of pregnancy with less than 72 hours before administration start or at screening. (4)The patients with bleeding varicose vein, the hepatic encephalopathy now, and need treatment. (5) The patients with other liver diseases by an anamnesis, liver biopsy or a laboratory study. (6) CP score 13 or more in the patients with cirrhosis. (7) Absolute non-curative resection case. (8) Recurrent case within 24 months after the HCC radical operation. (9) HIV infection (10)Pancreatitis within 24 weeks before study drug administration start. (11)The patients who were judged when alcoholism did not enable appropriate medication or raised the risk of hepatotoxicity and the pancreatitis. (12)The patients with difficulty in conducting a clinical trial by other serious conditions. (13)Serum creatinine levels exceed the twice the normal value upper limit, or eGFR<30mL/min or less. (14) Hemoglobin < 7.5 g/dL. (15) Platelet count < 50,000/mm3. (16) A granulocyte count < 1,500/ mm3. (17) The patients with allergic history by the nucleoside analog. (18)The patients who received immunosuppressive therapy within four weeks before therapeutic drug administration start. (19)The patients who received the IFN within 12 weeks before study. (20) The patients using ETV before. (21) The patients received the hepatitis B therapeutic drug (lamivudine) of the nucleoside analog. (22) The case that we continued surgery until just before that more than three months, and was given nucleic acid analog. (23) The patients who cannot be given it orally. (24) The patients who have difficulty in puncture of peripheral vessels. (25) The patients who are restricted forcibly by a legal reason or a mental disease, a physical disease (including the infection). (26) In addition, the patients that attending staff of this study judged that administration was inappropriate.
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