NCT01671046已完成不适用
Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 主要终点
- Correlation of liver elasticity evolution with viral kinetics
研究概览
简要总结
This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.
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 infection (mono-infection or co-infection with human immunodeficiency virus [HIV])
- •Detectable level of hepatitis C RNA
- •Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines
- •Last liver biopsy performed no later than 3 months prior to enrolment to study
排除标准
- •Co-infection with hepatitis B virus
- •Previous treatment with pegylated interferon and ribavirin
- •Participation in another clinical study in the last 12 months prior to study start
结局指标
主要结局
Correlation of liver elasticity evolution with viral kinetics
时间窗: 24 months
Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start
时间窗: 24 months
次要结局
- Correlation of hepatic steatosis score with sustained virological response(24 months)
- Correlation of liver fibrosis stages with sustained virological response (SVR)(24 months)
- Safety: incidence of adverse events(24 months)
- Hepatic transient elastography (M-transducer)(24 months)
- Hepatic transient elastography (XL-transducer)(24 months)
- Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients(24 months)
- Correlation of patients characteristics with sustained virological response(24 months)
- Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy(24 months)
研究者
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