NCT02000063已完成不适用
Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Long-term effects of HCV clearance
研究概览
简要总结
A single long-term follow up assessment of an established multi-centre, prospective longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes 4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.
详细描述
The study aims are:
- To evaluate the effect of successful prior treatment or spontaneous clearance of recently acquired HCV infection on long-term quality of life, social functioning, injecting behaviour, mental health and liver health.
- To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired chronic HCV infection.
- To determine predictors of HCV re-infection following recently acquired HCV infection treatment.
- To determine frequency and predictors of new mixed and superinfections in ATAHC subjects with persistent viraemia.
- To add to a tissue repository of serum and PBMCs from well-characterised patients treated for recently acquired HCV infection to allow future examination of the role of other variables that may potentially impact on the prognosis and outcomes of early HCV treatment.
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
- •Previous enrolment in the Australian Trial of Acute Hepatitis C Virus Infection (ATAHC) Study.
- •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
Long-term effects of HCV clearance
时间窗: 4 to 8 years from initial infection
Health related quality of life (measured by SF-12) Social functioning (measured by OTI survey) Injecting behaviour Mental health (measured by DASS and MINI) Liver health (measured by FibroScan and biochemical markers)
次要结局
- Incidence of HCV re-infection(4 to 8 years from initial infection)
研究者
研究点 (3)
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