临床试验/NCT01776814

NCT01776814Unknown不适用

Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

Gachon University Gil Medical Center1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2013年2月最近更新: 2013年1月28日

适应症

试验速览

阶段: 不适用
发起方: Gachon University Gil Medical Center
入组人数: 100
试验地点: 1
主要终点: virologic response

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•18 < Age < 70
•HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)
•HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)

排除标准

•With HCV or other liver disease
•With kidney disease
•decompensated liver cirrhosis
•with hepatocellular carcinoma
•refuse this clinical trials

结局指标

主要结局

virologic response

时间窗: changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir

Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir

次要结局

reduction of alanine transaminase(changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir)

研究者

发起方

Gachon University Gil Medical Center

申办方类型

Other

责任方

Principal Investigator

主要研究者

Ju Seung Kim, MD

principle investigator

Gachon University Gil Medical Center

研究点 (1)

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