NCT03125408终止不适用
Clinical Utility of the DxN HCV Assay as an Aid in the Management of HCV-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
- 210
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response (SVR)
研究概览
简要总结
The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in the intended use population.
详细描述
Same as brief
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 measurable HCV-RNA at baseline (prior to treatment start)
- •Subject is genotype 2 or 3 and plans to undergo treatment with Peginterferon (PEG) plus Ribavirin (RBV) or Sofosbuvir (SOF) plus RIB
- •Subject is genotype 1 and plans to undergo treatment with Telaprevir (TEL) or SOF plus PEG+RBV or, SOF plus Ledipasivr (LED)
- •Subject is able to under information given, and willing and able to voluntarily give their consent to participate in study including signing consent form.
排除标准
- •Co-infection with HIV or Hepatitis B (HBV)
- •Prior participation in study
- •Current participation in an investigation drug or device study
结局指标
主要结局
Sustained Virologic Response (SVR)
时间窗: Up to 9 months
Defined as unquantifiable HCV Viral load after discontinuation of therapy
次要结局
未报告次要终点
研究者
研究点 (1)
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