Gradual Withdrawal of Immunosuppression in Long Term Stable Liver Transplant Recipients Using Immunologic Profile Predicting Operational Tolerance
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- number of participants who have the potential for the operational tolerance
研究概览
简要总结
Long-term immunosuppression carries potential adverse effects such as risk of infection, malignancy, renal insufficiency, diabetes and hypertension. In clinical liver transplantation, some liver transplant recipients maintain allograft function without immunosuppressive drugs. This is called as "operational tolerance". Many attempts have been made to identify immunological biomarkers predicting operational tolerant patients. Therefore, the investigators aimed to identify patients who have the potential to be operationally tolerant using biomarkers, withdraw immunosuppressant gradually and stop ultimately with monitoring of biomarkers.
详细描述
Among long term stable liver transplant recipients, we will select some proportion of patients who have the high potential for obtaining operational tolerance using biomarkers.
Then, we will gradually reduce immunosuppressants and monitor biomarkers as well as biochemical tests. The course of tapering off immunosuppressant will take about 1 year.
During withdrawal of immunosuppression, participants will be closely monitored for liver enzyme, immunological profile.
If there are some signs of rejection, liver biopsy will be undertaken and participants will be treated using immunosuppressant.
After complete withdrawal of immunosuppressant, participants will be followed for at least of 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •long term stable liver transplant recipients
排除标准
- •liver transplant due to autoimmune disease
- •liver transplant due to hepatitis C virus (HCV)
- •history of graft rejection
- •history of biliary infection or stricture
结局指标
主要结局
number of participants who have the potential for the operational tolerance
时间窗: in the 2 years fololowing study enrollment
measure number of patients who can be weaned off immunosuppression completely
次要结局
- Tolerance biomarker(1 year following immunosuppression withdrawal)
- immunologic profile related to rejection(up to 2 years following withdrawal of immunosuppression)