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临床试验/NCT01732081
NCT01732081Unknown不适用

Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
to determine factors associated with the outcome of chronic HBV infection

研究概览

简要总结

It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

排除标准

  • Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
  • Decompensated cirrhosis
  • History of liver transplantation
  • History of hepatocellular carcinoma (HCC)

结局指标

主要结局

to determine factors associated with the outcome of chronic HBV infection

时间窗: 10 years

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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