Hepatitis Delta Registry and Research Network- Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 18
- 主要终点
- Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide
研究概览
简要总结
Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. To improve the current therapeutic options, a better understanding of the pathophysiology is essential. Reliable research in this direction is only possible with large patient study groups. However, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.
详细描述
The hepatitis international network cohort is a multicenter, observational study that will build up a research registry of HDV patients all over the world.
The aims of this project are:
i. Collect clinical information from hepatitis delta patients from multiple centers distributed worldwide in order to build up a large database that will enable and facilitate further research on chronic hepatitis delta.
ii. To better inform patients about their viral infection, present status and evolution of liver disease throughout time. To give them the tools needed to inform other peers and medical professionals about the significance and consequences of a chronic hepatitis delta infection.
iii. To allow the participating physicians to track course of the disease, therapies, signs and symptoms of the hepatitis delta patients included by their center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive HBs antigen and antiHDV for longer than 6 months.
排除标准
- •Absence of any cause of relevant liver disease other than HDV (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)
结局指标
主要结局
Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide
时间窗: 10 years
次要结局
- HDV-RNA HBsAg(10 years)
- HBV-DNA(10 years)
- Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide(10 years)