NCT03236584Unknown3 期
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial
Uijeongbu St. Mary Hospital0 个研究点目标入组 76 人开始时间: 2015年9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
- 76
- 主要终点
- SVR
研究概览
简要总结
Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir 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) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval
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
lamivudine adefovir
Active Comparator
干预措施: lamivudine plus adefovir combination (Drug)
tenofovir
Experimental
干预措施: Tenofovir Disoproxil Fumarate (Drug)
结局指标
主要结局
SVR
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
相似试验
Unknown
3 期
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus TenofovirProportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48NCT03236610Uijeongbu St. Mary Hospital112
撤回
4 期
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招募中
不适用
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trialchronic hepatitis BJPRN-UMIN000021793Department of Hepatology, Osaka Metropolitan University90
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TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus DNAChronic Hepatitis BNCT01732367Keimyung University Dongsan Medical Center171
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