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临床试验/NCT04593355
NCT04593355已完成不适用

HCV Epidemiological Survey of Chinese in Northeast Rural Area Which Have Injection History

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 6,068 人开始时间: 2009年12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
6,068
试验地点
1
主要终点
Blood Anti-HCV

研究概览

简要总结

The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese population.

详细描述

Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million patients. More importantly, many of those patients with chronic hepatitis C eventually develop cirrhosis and hepatocellular carcinoma(HCC).Our survey found the rate of hepatitis c infection in northeastern China without intervention is 34.3%, due to the abuse of caffeine sodium benzoate. This population has the similar mode of transmission, which is a fine study of the natural outcome hepatitis C. We plan to carry out epidemiological studies for this population, review of the influencing factors of the disease, and analyze the host factors that can effect the prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged from 20 to 65

排除标准

  • Has history of decompensated liver diseases
  • Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
  • Has a history of autoimmune hepatitis
  • History of a severe seizure disorder or current anticonvulsant use
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
  • History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

结局指标

主要结局

Blood Anti-HCV

时间窗: Baseline

Co-infection status are analyzed.

次要结局

  • HCV genotype(Baseline)
  • Fibrosis stage(Baseline)
  • Alcohol ,smoking condition(Baseline)
  • Blood HCV RNA Copies(Baseline)
  • Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)(Baseline)
  • Regular blood test(Baseline)
  • Drug abuse history(Baseline)

研究者

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

Junqi Niu

Vice-President of First Hospital of Jilin University

The First Hospital of Jilin University

研究点 (1)

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