临床试验/NCT01376154

NCT01376154已完成不适用

Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

GlaxoSmithKline0 个研究点目标入组 342 人开始时间: 2006年6月最近更新: 2017年5月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 342
主要终点: Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Other

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer

排除标准

•Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet
•Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet

研究组 & 干预措施

Subjects prescribed lamivudine tablet

Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period

干预措施: Lamivudine (Drug)

结局指标

主要结局

Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet

时间窗: 6 months or more

次要结局

未报告次要终点

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

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