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
- 否
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
Chang Wook Kim
C.W. Kim
Uijeongbu St. Mary Hospital
研究点 (1)
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