A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 770
- 试验地点
- 42
- 主要终点
- Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.
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
- None
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
- •18~65 years
- •Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
- •HCV RNA≥2000IU/mL, anti-HCV positive at screening
- •Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
- •Signed informed consent
排除标准
- •Pregnant or lactating women
- •Mental or psychology disorder
- •ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal)
- •Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
- •Co-infection with HIV, HAV, HBV, HEV
- •Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L)
- •Hepatocarcinoma or suffering from any other malignant tumor
- •Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
- •Significant function damage in any major organs (e.g: heart, lung, kidney)
- •Involved in other investigation within the previous 3 months
- •Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)
研究组 & 干预措施
A1(Genotype2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
干预措施: Ypeginterferon alfa-2b (Drug)
A2(Genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 800mg/day
干预措施: Pegasys (Drug)
B1(Non-genotype 2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
干预措施: Ypeginterferon alfa-2b (Drug)
B2(Non-genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
干预措施: Pegasys (Drug)
结局指标
主要结局
Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy)
时间窗: 24 weeks after the end of therapy
次要结局
- Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml)(at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3)