NCT01200225已完成不适用
Prospective Observational Study to Asses the Insulin Resistance (IR) and Its Impact on Sustained Virological Response in a Cohort of HCV-infected Patients Treated With Pegasys and Copegus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,155
- 主要终点
- Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)
研究概览
简要总结
This prospective observational study will assess the insulin resistance and its impact on sustained virological response in patients with hepatitis C treated with Pegasys and Copegus. Data will be collected from each patient during the up to 72 weeks of treatment and for 24 weeks of treatment-free follow-up.
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
- •Adult patients, >/= 18 years of age
- •Chronic hepatitis C (detectable HCV RNA)
- •Initiation of treatment with Pegasys and Copegus
排除标准
- •Participation in a clinical trial during the study
结局指标
主要结局
Effect of insulin resistance, defined as HOMA index > 2, on sustained virological response (HCV RNA assessed by Polymerase Chain Reaction assay)
时间窗: 42 months
次要结局
- Quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)(42 months)
- Safety: Incidence of adverse events(42 months)
- Host-, virus- and treatment-related factors influencing virological response and sustained virological response(42 months)
- Parameters of metabolic syndrome(42 months)
- Management of insulin resistance(42 months)
- Patient characteristics(42 months)
研究者
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