Post-marketing Clinical Trial of Pegasys® 180μg for Subcutaneous Injection in Patients With Chronic Hepatitis C. General Clinical Study in Interferon (IFN)-Treated and IFN-untreated Chronic Hepatitis C Patients, Except for Those Infected With High Viral Load of Genotype 1b
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Sustained viral response as undetectable level of HCV-RNA
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL).
In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Quantitative serum HCV-RNA is positive except for high viral load of genotype 1b (≥ 100 KIU/mL)
- •Observation of serum ALT elevation above upper limit of normal
- •Chronic hepatitis is evaluated as the negative result (< 0) calculated by the method of "formula for discrimination between chronic hepatitis and liver cirrhosis."
排除标准
- •Observation of white blood cells ≦ 3000/mm3; neutrophils ≦ 1500/mm3; platelets ≦ 90,000/mm3; or hemoglobin ≦ 10 g/dL.
- •Observation of the following situations and disease: severe renal disease, hepatitis B co-infection, de-compensated liver disease, liver cirrhosis, hepatocellular carcinoma, poorly controlled psychiatric disease, seizure disorders, immunologically mediated disease, severe cardiac disease, poorly uncontrolled hypertension, poorly controlled diabetes, chronic pulmonary disease, retinopathy, malignant tumor, and organ transplant
研究组 & 干预措施
1
Interferon (IFN)-Treated
干预措施: Pegasys® (Drug)
2
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1
干预措施: Pegasys® (Drug)
3
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
干预措施: Pegasys® (Drug)
4
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
干预措施: Pegasys® (Drug)
结局指标
主要结局
Sustained viral response as undetectable level of HCV-RNA
时间窗: week 24 from the end of treatment
次要结局
- Biochemical response as normal level of ALT(week 24 from the end of treatment)
- Viral response as undetectable level of HCV-RNA(at the end of treatment)