Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 535
- 试验地点
- 3
- 主要终点
- Sustained virological response (SVR)
研究概览
简要总结
The Chinese patients with chronic hepatitis C have a different genetic background, which had been demonstrated to significantly influence their responses to pegylated interferon and ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6 infection were treated with pegylated interferon and ribavirin. Their response was compared amongst different genotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA is positive
- •Treatment naive
- •Come from China
排除标准
- •Active substance abuse
- •Poorly controlled psychiatric disease
- •HBsAg positive
- •Anti-HIV positive
- •Suffering from other significant concurrent medical conditions including chronic liver diseases
研究组 & 干预措施
Genotype 6
Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
干预措施: 48-weeks course (Drug)
Genotype 6
Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
干预措施: Ribavirin (Drug)
Genotype 1
Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
干预措施: 48-weeks course (Drug)
Genotype 1
Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
干预措施: Ribavirin (Drug)
Genotype 2/3
Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks
干预措施: Peginterferon alfa2a (Drug)
Genotype 2/3
Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained virological response (SVR)
时间窗: 24 weeks after the end of treatment
Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment
次要结局
- Sick leave in patients treated for 24 or 48 weeks treatment(48 weeks)
- Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment(24 weeks after the end of treatment)
研究者
Cai Qingxian
Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University