Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 8
- 主要终点
- Sustained Virologic Response (SVR)
研究概览
简要总结
This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Interferon and rivavirin
All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of >75 kg) daily.
干预措施: peginterferon alfa-2a (Drug)
Interferon and rivavirin
All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of >75 kg) daily.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Virologic Response (SVR)
时间窗: 24 weeks after therapy is discontinued
The primary end point of therapy was an SVR that was definied as the absences of detectable HCV RNA in serum 24 weeks after therapy was stopped.
次要结局
未报告次要终点