NCT03123159终止不适用
Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Sustained Virologic Response (SVR)
研究概览
简要总结
The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.
详细描述
Same as brief summary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or older
- •Subject has serological evidence of chronic HBV infection, and measurable HBV-DNA and ALT at baseline
- •Subject will undergo treatment with tenofovir or entecavir for a minimum of 48 weeks
排除标准
- •Co-infection with HIV or HCV at enrollment
- •Subject has decompensated liver disease or liver cancer
- •Prior participation in study
- •Current or planned participation in an investigational drug or device study
结局指标
主要结局
Sustained Virologic Response (SVR)
时间窗: Up to 48 weeks
Defined as unquantifiable HBV Viral load at 48 weeks of treatment.
次要结局
未报告次要终点
研究者
研究点 (10)
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