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临床试验/NCT01293279
NCT01293279已完成不适用

HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 997 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
997
试验地点
1
主要终点
Hepatitis C viral and host genotypes

研究概览

简要总结

The primary objective of this study is to estimate the distributions of HCV viral/human genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at the time the study is conducted.

详细描述

A sample of 1000 Han ethnic Chinese male or female who are ≥ 18 years old with a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study is to estimate the distributions of HCV Viral genotyping(ie, genotype 1 through 6 and their known subtypes), and host genotypes, both inosine triphosphatase (ITPA) gene, and IL28B. This study also collects other data including patients' demographic and clinical characteristics. There is no active antiviral treatments and no follow-up in this study.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female
  • Han ethnic
  • ≥ 18 years old
  • recent confirmation of anti-HCV-antibody positive and HCV RNA positive 30 days prior to the recruitment
  • antiviral or interferon treatment naive

排除标准

  • < 18 years old
  • not Han ethnic
  • treated by antiviral before this study

结局指标

主要结局

Hepatitis C viral and host genotypes

时间窗: Confirmation of an HCV infection 30 days prior to the recruitment

To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients

次要结局

  • Hepatitis C RNA levels(Confirmation of an HCV infection 30 days prior to the recruitment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lai Wei

Professor

Peking University People's Hospital

研究点 (1)

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