Disease Progression and Intervention of Chronic HepatitisB Based on Diabetes and Hyperlipidemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Efficacy of NAs therapy
研究概览
简要总结
HBV(hepatitis B virus) with metabolic comorbidities may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported combination of metabolic diseases and CHB is associated with substantially increased rates of liver cirrhosis and secondary liver-related events compared to CHB alone. Consequently, hepatitis B patients with metabolic comorbidities warrant particular attention in disease surveillance and evaluation of treatment indications.
详细描述
Primary objective:
To evaluate the impact of metabolic disease on the progression of chronic hepatitis B
- To observe HBsAg/HBeAg/HBV DNA changes /HBsAg seroconversion
- To determine high rates of Liver Cirrhosis and Hepatocellular Carcinoma
Group 1 : CHB with diabetes Group 2 : CHB with hyperlipemia Group 3 : CHB without metabolic diseases
Study Duration (in months) 24 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
- •Patients on-treatment with NAs
排除标准
- •Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- •History of depression or uncontrolled psychiatric disorders
- •Subjects protected by law or not in a position to give consent
结局指标
主要结局
Efficacy of NAs therapy
时间窗: 2 year
We will follow up patients every six months and all patients with a history of hepatitis B will be tested for HBsAg(+) and HBD-DNA.The curative effect was evaluated by observing the changes of serological indexes.
次要结局
- Incidence of liver fibrosis and cirrhosis(2 year)
研究者
Hong Ren
Principal Investigator
The Second Affiliated Hospital of Chongqing Medical University