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Early Prediction of Successful Treatment for Chronic Hepatitis C Virus Infection in Taiwan

2008年11月20日 更新者：National Taiwan University Hospital

Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). Recently, treatment with peginterferon alfa plus ribavirin has become the standard of care for patients with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only 40-50%. In contrast, genotype 1 Taiwanese patients have superior SVR rates than those in Western countries. Despite the overall improved response to this combination therapy, more than 75% of patients suffer from treatment-related adverse events and the costs remain high, which make individualized therapy of paramount importance to maximize treatment response and minimize adverse events.

HCV viral kinetics with interferon-based therapies have been studied recently to evaluate patient responses. Early viral kinetics shown to have favorable SVR rates, which make shorter treatment duration possible. However, different viral kinetics were found through ethnicity. Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV infection who received peginterferon alfa plus ribavirin therapy has shown superior early viral kinetics to those in Caucasian patients. Based on the favorable SVR rates in treating Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for these patients.

研究概览

地位

未知

条件

干预/治疗

详细说明

Hepatitis C virus (HCV) infection is a global health problem, which may lead to chronic hepatitis, cirrhosis, hepatic decompensation and hepatocellular carcinoma (HCC). [1,2] Recently, treatment with peginterferon alfa plus ribavirin has become the standard of care for patients with chronic hepatitis C. While genotype 2 patients can have higher sustained virologic response (SVR) rates to 80-90%, genotype 1 patients generally have low SVR rates of only 40-50%. [3-5] In contrast, genotype 1 Taiwanese patients have superior SVR rates that those in Western countries. [6,7] Despite the overall improved response to this combination therapy, more than 75% of patients suffer from treatment-related adverse events and the costs remain high, [8,9] which make individualized therapy of paramount importance to maximize treatment response and minimize adverse events.

HCV viral kinetics with interferon-based therapies have been studied recently to evaluate patient responses. [10-14] Early viral kinetics shown to have favorable SVR rates, which make shorter treatment duration possible. [15-18] However, different viral kinetics were found through ethnicity. [19-23] Recently, a pilot study to evaluate the viral kinetics of 6 Taiwanese patients with HCV infection who received peginterferon alfa plus ribavirin therapy has shown superior early viral kinetics to those in Caucasian patients. [24] Based on the favorable SVR rates in treating Taiwanese patients with chronic hepatitis C, the investigators aimed to conduct a large confirmatory study to evaluate the viral kinetics and try to define the optimal treatment for these patients.

研究类型

观察性的

注册 (预期的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Ramat-Gan、以色列
        • 招聘中
        • Faculty of Life Sciences, Bar-Ilan University
        • 首席研究员：
          • Avidan Uriel Neumann, MD, PhD
  • 台湾
      • Douliou、台湾
        • 招聘中
        • National Taiwan University Hospital, Yun-Lin branch
      • Taichung、台湾
        • 招聘中
        • Taichung Veterans General Hospital
        • 首席研究员：
          • Sheng-Shun Yang, MD
      • Taipei、台湾、100
        • 招聘中
        • National Taiwan University Hospital
        • 副研究员：
          • Chen-Hua Liu, MD
        • 副研究员：
          • Chun-Jen Liu, MD,PhD
      • Taipei、台湾
        • 招聘中
        • Far Eastern Memorial Hospital
      • Taipei、台湾
        • 招聘中
        • Buddhist Tzu Chi General Hospital
      • Taipei、台湾
        • 招聘中
        • Ren-Ai Branch, Taipei Municipal Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients with chronic hepatitis C virus infection who receive pegylated interferon plus ribavirin for an overall of 24-48 weeks

描述

Inclusion Criteria:

  • Treatment naïve
  • Over 18 years old
  • Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
  • Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with dynamic range 600~< 500,000 IU/ml
  • Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
  • A liver biopsy consistent with the diagnosis of chronic hepatitis C

Exclusion Criteria:

  • Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
  • Neutropenia (neutrophil count < 1,500 per cubic milliliter)
  • Thrombocytopenia (platelet < 90,000 per cubic milliliter)
  • Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Chronic alcohol abuse (daily consumption > 20 gram per day)
  • Decompensated liver disease (Child-Pugh class B or C)
  • Serum creatinine level more than 1.5 times the upper limit of normal
  • Autoimmune liver disease
  • Neoplastic disease
  • An organ transplant
  • Immunosuppressive therapy
  • Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
  • Evidence of drug abuse
  • Unwilling to have contraception
  • Unwilling to receive serial blood sampling during the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
1
Patients with chronic hepatitis C who receive pegylated interferon plus ribavirin for 24 weeks (genotype 1 or 2) and for 48 weeks (genotype 1)
药品：Pegylated interferon alfa and ribavirin

Pegylated interferon alfa-2a 180 ug/week or pegylated interferon alfa-2b 1.5 ug/kg/week Ribavrin 800-1200 mg/day (genotype 1: < 75 kg 1000 mg/day, >=75 kg 1200 mg/day; genotype 2: 800 mg/day)

HCV genotype: baseline (Day 0) HCV RNA (real time PCR test): baseline (Day 0), Day 1 (4,8,12 hours after pegylated interferon + ribavirin), Day 2 (24,36 hours), Day 3(48 hours), Day 4 (72 hours), Day 5 (96 hours), Week 2,4,6,8,12,16,20,24, and 28,32,36,40,44,48,72 (for genotype 1 with 48 weeks of treatment), and 48 (for genotype 1 or 2 with 24 weeks of treatment)

其他名称：
  • Pegasys 加 Robatrol
  • Peg-Intron plus Rebetol

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Sustained virologic response (SVR)
大体时间：1~1.5 years
1~1.5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Taiwan University Hospital

合作者

National Science Council, Taiwan

调查人员

  • 首席研究员：Chen-Hua Liu, MD、National Taiwan University Hospital
  • 学习椅：Jia-Horng Kao, MD, PhD、National Taiwan University Hospital
  • 首席研究员：Avidan Uriel Neumann, PhD、Faculty of Life Sciences, Bar-Ilan University, Ramat-Gan, Israel

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年1月1日

初级完成 (预期的)

2008年10月1日

研究完成 (预期的)

2008年12月1日

研究注册日期

首次提交

2007年10月10日

首先提交符合 QC 标准的

2007年10月10日

首次发布 (估计)

2007年10月12日

研究记录更新

最后更新发布 (估计)

2008年11月21日

上次提交的符合 QC 标准的更新

2008年11月20日

最后验证

2008年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 200709053R

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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