The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 14
- 主要终点
- Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a
研究概览
简要总结
- Randomized controlled multicenter study
- The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
- IL28B polymorphism in Koreans with CHC
详细描述
The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.
-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).
So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.
There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.
-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hepatitis C (anti HCV+, HCV RNA +)
- •Genotype 1
- •over 18 year-old
- •Pregnancy test negative if women of childbearing age
排除标准
- •pregnant women or breast feeding women
- •systemic chemotherapy or steroid therapy before 6 months of trial
- •Coinfection with HAV, HBV, and HIV
- •Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis
- •Hepatocellular carcinoma
- •Evidence of decompensation such as variceal bleeding,ascites, encephalopathy
- •ANC less than 1500, platelet less than 90k
- •Cr more than 1.5 of UNL
- •Severe psychiatric problem
- •Poorly controlled thyroid disease
- •Severe retinopathy
研究组 & 干预措施
80% dosage group of peginterferon alfa 2a
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
干预措施: peginterferon alfa 2a (pegasys) (Drug)
100% dosage group of peginterferon alfa 2a
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
干预措施: peginterferon alfa-2a (pegasys) (Drug)
结局指标
主要结局
Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a
时间窗: post treatment 24 weeks
We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
次要结局
- IL28B Polymorphism Effect on SVR(post treatment 24 weeks)
研究者
Jung Hyun Kwon
Assistant professor
The Catholic University of Korea