NCT02877199已完成不适用
Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Proportion of patients with positive anti-E1E2 antibody level at treatment initiation
研究概览
简要总结
The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •HCV patients with compensated cirrhosis (Child-Pugh A)
- •HCV genotype 1
- •non-responders to a previous course of interferon (IFN)/ribavirin
- •receiving boceprevir or telaprevir
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with positive anti-E1E2 antibody level at treatment initiation
时间窗: Baseline (initiation of treatment)
Anti-E1E2 antibody levels were determined as previously described (Ndongo et al. Hepatology 2010;52:1531-42) using optical densities obtained after dilution of patients' serum samples at 1/250 and 1/500. Samples with anti-E1E2 levels above 950 (OD value× 1000) were considered positive.
次要结局
- Kinetic of Quantification of hepatitis C viral load (HCV RNA)(baseline (initiation of treatment), at week 4, 12, 24, 36, 48 of therapy, at 12 weeks after the end of treatment.)
研究者
研究点 (1)
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