Real World Study of Chronic Viral Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Virologic responses(for both chronic hepatitis B and C)
研究概览
简要总结
This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.
详细描述
Chronic viral hepatitis is defined as infectious liver disease caused by persistent virus infection for more than six months. Sustained viral replication and ongoing liver inflammation can eventually lead to liver fibrosis/cirrhosis or even hepatocellular carcinoma. Chronic viral hepatitis infection causes at least 80% of all liver cancers.
Though chronic viral hepatitis is a major global health concern, there is still a lack of evidence in high quality about the management of chronic viral hepatitis and the long-term outcome of patients. The concept of real-world data and research has been officially introduced into China since 2010. Real-world evidence, based on real-world data, can help practitioners have better understanding of the characteristics of the patients with different treatment strategies.
This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of patients.
- •Evidence of persistent virus infection for greater than six months [hepatitis C virus(HCV) RNA positive, hepatitis B surface antigen(HBsAg) or hepatitis B virus(HBV) DNA positive]
排除标准
- •Serious psychiatric history, especially depression.
- •Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness.
- •Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
- •Patients with malignant tumors (excluding those cured).
结局指标
主要结局
Virologic responses(for both chronic hepatitis B and C)
时间窗: 24 weeks after treatment initiation
Sustained virological response （Able to sustain an undetectable viral load for a period）
Serological responses(for chronic hepatitis B only)
时间窗: 48 weeks after treatment initiation
Hepatitis B e antigen (HBeAg) seroconversion(HBeAg loss and presence of anti-HBe) and hepatitis B surface antigen(HBsAg) seroconversion (HBsAg loss and presence of anti-HBs)
次要结局
- Histological responses(for both chronic hepatitis B and C)(48 weeks after treatment initiation)
研究者
Wen-hong Zhang
Chief of department of infectious disease
Huashan Hospital