A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 38
- 主要终点
- Efficacy
研究概览
简要总结
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.
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
- •Age: 18~65 years.
- •Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
- •Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C.
- •HCV RNA≥2000IU/ml.
排除标准
- •Pregnant or lactating women.
- •Mental disorder or physical disability.
- •WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm
- •Received interferon treatment within the previous 6 months or shew no response to interferon.
- •Co-infection with HIV, HAV, HBV, HEV.
- •Evidence of hepatic decompensation.
- •Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- •History of hypothyroidism or current treatment for thyroid disease.
- •Diabetes mellitus.
- •Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.
研究组 & 干预措施
Group 1
Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
干预措施: Ypeginterferon alfa-2b (Drug)
Group 2
Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
干预措施: Ypeginterferon alfa-2b (Drug)
Group 3
Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
干预措施: Ypeginterferon alfa-2b (Drug)
Group 4
Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
Efficacy
时间窗: week 12
Proportion of patients with HCV RNA undetectable at week 12.
次要结局
- Efficacy(Week 4, 12, 24, 48 and 72)