Collection of Plasma Samples From Individuals Initiating Therapy With Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 88
- 主要终点
- Association between virologic response at Week 24 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
研究概览
简要总结
This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.
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
- •The subject is chronically infected with HBV.The subject is treatment naïve and is initiating HBV antiviral therapy with either entecavir or tenofovir as indicated in the FDA approved label
- •The subject will be considered treatment naïve if he/she had <12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
- •The subject is at least 18 years of age at the time of enrollment
- •Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
- •The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)
排除标准
- •Subject is in one of the following patient populations:
- •Acute HBV infection
- •Patients who are HBV immune tolerant
- •Human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) co-infection
- •Solid organ or bone marrow transplant recipients
- •Renal failure or dialysis
- •Evidence or history of hepatic decompensation
- •Evidence or history of hepatocellular carcinoma
- •Underlying liver disease other than HBV
- •Receiving chemotherapy, immunosuppressive agents
- •Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
- •Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study
结局指标
主要结局
Association between virologic response at Week 24 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
时间窗: Week 48 (from start of therapy)
Virologic response is defined as HBV DNA levels less than the lower limit of quantitation at the assessed time point. Association will be measured as an odds ratio.
Association between virologic response at Week 12 (assessed using the Aptima HBV Quant assay) and virologic response at Week 48 (assessed using an FDA-approved HBV quant assay).
时间窗: Week 48 (from start of therapy)
Virologic response is defined as HBV DNA levels less than the lower limit of quantitation at the assessed time point. Association will be measured as an odds ratio.
次要结局
未报告次要终点