Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With Chronic Hepatitis B Combined With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Risk factors for hepatic inflammation or fibrosis in chronic hepatitis B patients with non-alcoholic fatty liver disease
研究概览
简要总结
Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, with the improvement of living standards and changes in lifestyle and dietary habits, non-alcoholic fatty liver disease (NAFLD) has become another important cause of liver cirrhosis and HCC.HBV combined with NAFLD inevitably develops into continuous or intermittent liver inflammation and fibrosis, which greatly increases the risk of cirrhosis, liver cancer and even end-stage liver disease. We aimed to investigate the risk factors and establish diagnostic models for hepatic inflammation, fibrosis in patients with CHB associated NAFLD. In addition, to find risk factors for liver cirrhosis, liver cancer or liver failure in patients with CHB-related NAFLD.
详细描述
Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, with the improvement of living standards and changes in lifestyle and dietary habits, non-alcoholic fatty liver disease (NAFLD) has become another important cause of liver cirrhosis and HCC.HBV combined with NAFLD inevitably develops into continuous or intermittent liver inflammation and fibrosis, which greatly increases the risk of cirrhosis, liver cancer and even end-stage liver disease. We aimed to investigate the risk factors and establish diagnostic models of hepatic inflammation and fibrosis in CHB associated NAFLD patients using a multicenter study. In addition, to find risk factors for liver cirrhosis, liver cancer or liver failure in patients with CHB-related NAFLD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18 years or older
- •Positive hepatitis B surface antigen (HBsAg) for at least 6 months and without other viral co-infection at baseline 2.NAFLD diagnosed by imaging liver biopsy, and/or blood testing/predictive indices
排除标准
- •Other chronic liver diseases, such as alcoholic liver disease, other viral hepatitis, drug-induced liver injury;
- •HCC or other malignancies before liver biopsy;
结局指标
主要结局
Risk factors for hepatic inflammation or fibrosis in chronic hepatitis B patients with non-alcoholic fatty liver disease
时间窗: 0 year
Risk factors for hepatic inflammation or fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease at baseline
Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure
时间窗: 5 years
Risk factors of chronic hepatitis B patients with non-alcoholic fatty liver disease progressing to cirrhosis, liver cancer or liver failure during 5-year follow-up
次要结局
- Establishment a diagnostic model for hepatic inflammation in chronic hepatitis B patients with non-alcoholic fatty liver disease(0 year)
- Establishment a diagnostic model for hepatic fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease(0 year)
- Establishment predictive models for the progression of chronic hepatitis B patients with non-alcoholic fatty liver disease to cirrhosis, liver cancer or liver failure(5 years)
- Incidence of cirrhosis, cancer and liver failure in patients with chronic hepatitis B and non-alcoholic fatty liver disease(5 years)
研究者
Jie Li
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School