Multicenter Study on Efficacy of New Therapeutic Schedules With Peg-Interferon alpha2b and Ribavirin in Patients With Genotype 3 Chronic HCV( Hepatitis C Virus) Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 7
- 主要终点
- Sustained virological response (SVR)
研究概览
简要总结
The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.
详细描述
Patients are randomized to standard length of treatment or to a variable duration: 12 weeks for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable HCV RNA at week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive HCV patients
- •HCVRNA positive
- •Normal TSH
- •ANA <1:160
排除标准
- •Portal hypertension
- •Renal failure
- •HBsAg or HIV
- •Alcohol consumption >30 g/day
- •Active IV drug use
- •Chronic systemic diseases
研究组 & 干预措施
B 1 I or II
In the variable treatment group, patients with a virologic response at week 4 will receive treatment for 12 weeks and those without a virologic response at 4 weeks treatment for 36 weeks. Patients without RVR will be treated for 24 or 36 weeks and labelled (B1I) or (B1II, respectively Intervention: different durations of treatment for patients without RVR
干预措施: Peg Interferon alpha2b + Ribavirin (Drug)
结局指标
主要结局
Sustained virological response (SVR)
时间窗: 6 months after the end of treatment
The primary measure of efficacy will be HCV RNA not detectable in the serum 24 weeks after the end of therapy (SVR). In addition, virological response at the end of treatment and relapse rates will be calculated for each groups. Two analyses will be performed: 1) intention-to-treat analysis; 2) per-protocol analysis.
次要结局
未报告次要终点