HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
试验速览
- 阶段
- 3 期
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- HBsAb level at 4 weeks after complete vaccine injection
研究概览
简要总结
Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion.
There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic Hepatitis B infection group
- •18-80 year-old
- •Compensated liver disease
- •Chronic HBV infection with or without NUCs treatment
- •History of HBsAg positive > 6 months
- •HBsAg negative with qualitative Elecsys (Roche) twice at least 6 months apart
- •HBsAb negative
- •HBV DNA < 20 IU/mL
- •Healthy group
- •Healthy person without history of HBV vaccination (HBsAg, anti-HBc and HBsAb negative)
排除标准
- •History of previous HBV vaccination
- •Anti-HCV and/or anti-HIV positive
- •Decompensated cirrhosis
- •History of previous malignancies
- •History or currently receive immunotherapy, cytotoxic or immunosuppressive agents
- •Patient with immunodeficiency disease
- •Creatinine > 1.5 mg/dL
- •Pregnancy or lactating woman
- •Unable to consent
研究组 & 干预措施
Healthy control
Commercial Hepatitis B vaccine
干预措施: Commercial Hepatitis B vaccine (Drug)
Chronic hepatitis B with vaccination
Commercial Hepatitis B vaccine
干预措施: Commercial Hepatitis B vaccine (Drug)
Chronic hepatitis B with vaccination
Commercial Hepatitis B vaccine
干预措施: Standard Treatment (Other)
Chronic hepatitis B without vaccination
Standard treatment
干预措施: Standard Treatment (Other)
结局指标
主要结局
HBsAb level at 4 weeks after complete vaccine injection
时间窗: an average of 7 months
HBsAb level more than 10 mIU/ml at 7 months
次要结局
- HBsAb level at 6 months after complete vaccine injection(an average of 1 year)
- Adverse event from HBV vaccine(an average of 1 year)
- Factors associated with HBV vaccine response(an average of 1 year)