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临床试验/NCT03236610
NCT03236610Unknown3 期

Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized Open-label Controlled Trial

Uijeongbu St. Mary Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
112
试验地点
1
主要终点
SVR at week 48

研究概览

简要总结

Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM(rtL180M and/or M204V/I) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months

排除标准

  • Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

研究组 & 干预措施

tenofovir plus entecavir

Active Comparator

干预措施: tenofovir plus entecavir combination (Drug)

tenofovir

Experimental

干预措施: tenofovir monotherapy (Drug)

结局指标

主要结局

SVR at week 48

时间窗: 48 week

Proportion of patients with a sustained virological response (serum HBV DNA \<20 IU/mL) at week 48

次要结局

未报告次要终点

研究者

发起方
Uijeongbu St. Mary Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Wook Kim

C.W. Kim

Uijeongbu St. Mary Hospital

研究点 (1)

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