NCT01750216已完成不适用
An Observational Study of Peginterferon-alfa-2a (Pegasys) and Ribavirin (Copegus) on Predictive Values of RVR on Sustained Virological Response (SVR) in Different Stage of Liver Fibrosis in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 主要终点
- Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1
研究概览
简要总结
This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of 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 genotype 1
- •Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
- •Confirmed serum positive HCV RNA
- •Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment
排除标准
- •Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
- •Co-infection with hepatitis B or HIV
- •Post-transplant patients
- •End stage renal disease (creatinine clearance < 15 ml/min)
- •Patients treated with immunotherapy
- •Pregnant women and male partners of women who are pregnant
- •Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter
结局指标
主要结局
Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1
时间窗: approximately 3 years
次要结局
- Safety: Incidence of adverse events(approximately 3 years)
- Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3)(approximately 3 years)
- Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1(approximately 3 years)
研究者
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