Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- The proportion of patients achieving sustained virological response (SVR)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.
详细描述
A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all of below
- •adults aged 18-70 years
- •serum anti-HCV antibody (+)
- •HCV RNA detectable by PCR
- •compensated liver disease (Child-Pugh class A)
排除标准
- •any of below
- •HCV genotype other than 1, 2, or 3
- •acute hepatitis C
- •decompensated cirrhosis or hepatocellular carcinoma
- •other liver disease such as hepatitis A or B, or autoimmune hepatitis
- •HIV Ab(+)
- •severe depression or other psychiatric disease
- •previous organ transplantation
- •absolute neutrophil count (ANC) < 1,000 cells/mm3 or platelet count < 75,000 cells/mm3, or hemoglobin (Hb) < 13 g/dL for men, <12 g/dL for women
研究组 & 干预措施
Korean CHC
Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008.
干预措施: Peginterferon alfa-2a plus ribavirin for HCV genotype 1 (Drug)
Korean CHC
Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008.
干预措施: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3 (Drug)
结局指标
主要结局
The proportion of patients achieving sustained virological response (SVR)
时间窗: at 24 weeks after cessation of treatment
SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment
次要结局
- The proportion of patients achieving early virological response (EVR)(at 12 weeks of treatment)
- the proportion of patients achieving complete EVR (cEVR)(at 12 weeks of treatment)
- The proportion of patients achieving end-of-treatment response (ETR)(at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3)
研究者
Young-Suk Lim
Professor
Asan Medical Center