Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C

Kyushu University2 个研究点分布在 1 个国家目标入组 1,251 人开始时间: 2004年12月1日最近更新: 2009年8月11日

适应症

试验速览

阶段: 不适用
发起方: Kyushu University
入组人数: 1,251
试验地点: 2
主要终点: antiviral effect by PEG-IFN alpha-2b plus RBV treatment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).

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: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July
•All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.

排除标准

•Clinical or biochemical evidence of hepatic decompensation.
•Advanced cirrhosis identified by large esophageal varices (F2 or F3).
•History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
•Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.
•Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
•Excessive active alcohol consumption > 60 g/day or drug abuse.
•Severe psychiatric disease.
•Antiviral or corticosteroid therapy within 12 months prior to the enrollment.

结局指标

主要结局

antiviral effect by PEG-IFN alpha-2b plus RBV treatment

时间窗: 24-weeks follow-up after the end of treatment

次要结局

the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment(during PEG-IFN alpha-2b plus RBV treatment (48 weeks))

研究者

发起方

Kyushu University

申办方类型

Other

研究点 (2)

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