The Investigation of Transplant Tolerance and Immunosuppressant Withdrawal Based on Parenchymal Chimerism in the Liver
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Recipient Cells in the Liver Allograft
研究概览
简要总结
The goal of this clinical trial is to learn whether liver parenchyma chimerism can represent a chievement of operational tolerance in liver transplantation recipients. The researchers will examine the degree of parenchyma chimerism. The participants will withdraw or minimize their immunosuppression to avoid the adverse effects of immunosuppressants.
详细描述
After liver transplantation, immunosuppression should be induced or maintained to prevent acute cell-mediated rejection or chronic antibody-mediated rejection.All these immunosuppressive agents have various adverse effects including nephrotoxicity, neurotoxicity, hyperglycemia, hypertension, bone marrow suppression, gastrointestinal disturbance, etc. We examine the liver specimen from long-term liver transplant recipients with stable liver function. The liver showed chimeric change of the liver. Therefore, the hypothesis of this study is that immunosuppressive agents can be withdrawn if the liver becomes chimeric. The specific aims of this study are:
- To determine whether the liver allografts become chimeric in long-term liver transplant recipients.
- To determine the degree of liver chimerism in long-term liver transplant recipients.
- To determine whether immunosuppression can be withdrawn based on liver chimerism.
Based on the degree of chimeric change of the liver grafts, immunosuppression withdrawal can be conducted in this study and find out the indicator of immunosuppression withdrawal in liver transplantation setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. The patients had liver transplantation, either deceased liver or liver donor, for ≥ 5 years.
- •b. Age ≥ 20 years old. c. The patients have stable liver function, and do not have clinical suspicious of acute cell-mediated rejection within 1 year.
- •d. Sign the informed consent. e. Platelet ≥ 80000/mm
- •f. INR ≤ 1.4 g. AST and ALT ≤ 1.5X h. Albumin ≥ 3.5gm/dl. i. Total bilirubin < 1.5mg/dl. j. ECOG ≤ 2
排除标准
- •a. Liver transplantation less than 5 years b. Abnormal liver function AST and ALT > 1.5X c. Severe infection d. De novo malignancy e. Disagree to have liver biopsy. f. ECOG > 2
结局指标
主要结局
Percentage of Recipient Cells in the Liver Allograft
时间窗: 1 year
Short tandem repeat (STR) analysis is used to calculate the chimeric percentage of recipient cells in the liver parenchyma.
次要结局
- Number of Participants with Successful Complete Immunosuppression Withdrawal(up to 1 year)
- AST Levels(up to 1 year)
- ALT Levels(up to 1 year)
- eGFR (Estimated Glomerular Filtration Rate)(At 3 months after immunosuppression withdrawal)
- HbA1c (Glycated Hemoglobin)(At 3 months after immunosuppression withdrawal)
- Cholesterol Profiles(At 3 months after immunosuppression withdrawal)
研究者
Wei-Chen Lee
Director, liver transplantation program
Chang Gung Memorial Hospital