Swiss Autoimmune Hepatitis Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 20
- 主要终点
- Disease course
研究概览
简要总结
Research project in which biological material is sampled and health-related personal data is further used and collected.
Coded data are used.
详细描述
To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, a biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on AIH. In addition, the cohort will allow collaborations with reference networks on AIH abroad.
Measurements and procedures: Enrolment visit and one follow-up visit at least once a year are planned. An additional follow-up visit at 6 months postdiagnosis is planned for newly diagnosed patients.
Whole blood is collected for biobanking once a year Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.
Number of subjects projected for the entire study (all sites combined): 500 (corresponding to 1/3 of the estimated global AIH population residing in Switzerland, assuming a disease prevalence of 20:100,000)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of AIH, either type I or type II
- •Only patients living in Switzerland
排除标准
- 未提供
结局指标
主要结局
Disease course
时间窗: 3 years
Observing disease course
Disease features
时间窗: 3 years
Observing disease features in Swiss population and see if they are similar to other countries'
Response to treatment
时间窗: 3 years
Observing response to treatment
Overall survival
时间窗: 3 years
Observing overall survival
Transplantation-free survival rate
时间窗: 3 years
Observing transplantation-free survival rate
次要结局
未报告次要终点