NCT02065999已完成不适用
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy.
研究概览
简要总结
This is a multi-centre prospective longitudinal cohort study with the aim of collecting and storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs for hepatitis C therapy.
详细描述
- To analyse for resistance-associated HCV variants in DAA-naïve HCV patients using population and ultra-deep pyrosequencing (UDPS). Resistance associated variants will be analysed by qualitative and quantitative methods both pre-treatment and on-treatment.
- To determine whether in the absence of drug pressure there is variation in the prevalence of naturally occurring resistance associated variants.
- To correlate the presence and frequency of baseline resistance-associated variants with the response to therapy with DAA-based triple therapy regimens for HCV.
- To identify predictors of emergent DAA resistance and treatment failure during therapy with DAA-based combination strategies, including virological, clinical and immunological factors.
- To characterize the natural history of HCV resistance associated variants that are selected during antiviral therapy after the withdrawal of treatment.
- To establish a cohort of DAA-treatment failure patients suitable for re-treatment studies.
- To establish a tissue repository of serum and PBMCs from well-characterized patients treated with DAA-based triple therapy to allow future examination of the role of other variables that may potentially impact on the outcomes of DAA based therapy and development of RAVs.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C infection
- •Commencing or expected to commence DAA-based HCV treatment within the next year
- •IFN treatment-naïve or IFN treatment-experienced
- •Provision of written, informed consent
排除标准
- •In the opinion of the investigator that the patient is not able to provide informed consent
- •Inability or unwillingness to comply with study collection requirements
结局指标
主要结局
Prevalence of HCV resistance associated variants (RAVs) and the incidence of RAVs arising during therapy.
时间窗: Baseline
Descriptive statistics will be used to describe RAVs using standard international nomenclature and presented in table form. Baseline clinical and demographic data on subjects will be presented, as will rates of treatment failure and reasons for failure.
次要结局
- Factors associated with treatment failure due to virological breakthrough / relapse.(Baseline)
研究者
研究点 (1)
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