A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response
试验速览
- 阶段
- 4 期
- 入组人数
- 164
- 试验地点
- 8
- 主要终点
- Sustained virologic response (SVR)
研究概览
简要总结
This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
详细描述
In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
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
- •Age older than 18 years old
- •Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- •Detectable serum quantitative HCV-RNA
- •HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
- •Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
排除标准
- •Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
- •History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- •Decompensated liver disease (Child-Pugh class B or C)
- •Neoplastic disease within 5 years
- •Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- •Women with ongoing pregnancy or breast feeding
- •Hgb < 11 g/dL in women or < 12 g/dL in men at screening
- •Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
- •Serum creatinine level > 1.5 times the upper limit of normal at screening
- •Serum alpha-fetoprotein > 100 ng/mL
- •History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- •History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •History of a severe seizure disorder or current anticonvulsant use
- •Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study
研究组 & 干预措施
A. 24 weeks in RVR patients.
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.
干预措施: Peginterferon alfa-2a and Ribavirin (Drug)
B. 16 weeks in RVR patients.
Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.
干预措施: Peginterferon alfa-2a and Ribavirin (Drug)
结局指标
主要结局
Sustained virologic response (SVR)
时间窗: 24 weeks post-treatment (week 40 or week 48)
次要结局
- AEs(up to 24 weeks after last treatment visit)
- laboratory parameters(up to 24 weeks after last treatment visit)
- vital signs(up to 24 weeks after last treatment visit)
研究者
Ki Tae Yoon
Assistant Professor
Pusan National University Yangsan Hospital