The European HBV Registry: a Joint Initiative of TherVacB and DZIF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Number of patients with seroconversion to anti-HBs
研究概览
简要总结
In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials.
Extensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies.
Furthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis B Virus Infection
- •TherVacB sub-cohort:
- •confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion
- •HBeAg status documented for at least 6 months
排除标准
- •TherVacB sub-cohort:
- •age >70 years
- •co-infection with HIV, HCV (RNA positive),
- •clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)
- •significant comorbidities (e.g. malignancies)
- •immunosuppressive treatment (> 40 mg Cortisol- equivalent)
- •liver cirrhosis (judged clinically or based on ultrasound/transient elastography)
- •History of hepatocellular carcinoma
结局指标
主要结局
Number of patients with seroconversion to anti-HBs
时间窗: 5 years
Measurement of quantitative HBsAg and anti-HBs levels
Number of patients with change HBsAg levels
时间窗: 5 years
Regular assessment of quantitative HBsAg levels
Quantification of IL6, IP-10, IFNg and IL1beta and correlation with HBsAg and ALT levels
时间窗: 5 years
Cytokine and Chemokine quantification in patients for subsequent correlation with viral parameters
次要结局
- Number of patients with hepatitis B related liver cirrhosis(5 years)
- Number of patients with hepatitis B related death(5 years)
- Number of patients with hepatitis B related increased or decreased quality of life(5 years)
- Number of patients with hepatitis B related HCC (hepatocellular carcinoma)(5 years)