NCT02090621已完成2 期
Extracorporeal Photopheresis After Liver Transplant. Phase II Clinical Trial on Safety and Efficacy in Patients With Progressive Withdrawal of Immunosuppression
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Non Serious Adverse Events
研究概览
简要总结
The purpose of this study is to determine the safety of photopheresis for prophylaxis of allograft rejection in patients who are being withdrawal immunosuppression after liver transplantation.
详细描述
The photopheresis (ECP) is a therapeutic approach based on the biological effect of ultraviolet light A on mononuclear cells collected by apheresis, and reinfused into the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver transplantation 2 years ago
- •>18 years
- •Treatment with immunosuppression (Cyclosporine or tacrolimus)
- •Normal hepatic function during last year
- •No acute or chronic rejection
- •to have some secondary effect because of immunosuppressors
- •Previous disease: alcoholic liver cirrhosis with or without hepatocarcinoma, metabolic disease, amyloid polyneuropathy, hepatitis,cryptogenic cirrhosis and non autoimmune causes
- •Signing consent informed form
排除标准
- •Additional liver Transplantation
- •hypersensitivity to methoxsalen
- •Patients with melanoma ,cutaneous carcinoma
- •Patients with aphakia
- •Patients treated with oxsoralen
- •Pregnant women, lactating women or fertile adults that they don´t use a effective anticonception method
- •Involved in other assay.
结局指标
主要结局
Non Serious Adverse Events
时间窗: 12 months
Allograft Rejection
时间窗: 12 months
Serious Adverse Events associated with the procedure
时间窗: 12 months
次要结局
- Renal Function test(12 months)
- Immunosuppressant level(12 months)
- Hematological Parameters(12 months)
- Immunological evaluation(12 months)
- Liver function test(12 months)
研究者
研究点 (2)
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