NCT01824368已完成1 期
FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- adverse event rate and rate of transplant rejection
研究概览
简要总结
The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been receiving liver transplant two years ago.
- •Be 18 years or older.
- •Treatment with immunosuppression including cyclosporine or tacrolimus.
- •Having a normal liver function in the last year
- •Not have suffered acute rejection in the last year and have no chronic rejection
- •Submit any significant side effects from medication immunosuppressive (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity novo malignancy, etc.)
- •Etiology of underlying disease: alcoholic cirrhosis with or without hepatocarcinoma, metabolic diseases, amyloidotic polyneuropathy family, biliary atresia, fulminant hepatitis non-A, non-B, non-C, cirrhosis cryptogenic and generally causes no viral or autoimmune.
- •Patients offering sufficient guarantees of adherence to protocol
- •Patients who give written informed consent for participate in the study.
- •It is necessary that the patient meets all inclusion criteria.
排除标准
- •Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) or epatocarcinoma about cirrhosis of viral or autoimmune.
- •Patients with chronic rejection, or acute rejection in the last year.
- •Patients with liver retransplantation.
- •patients with history of hypersensitivity or idiosyncratic reactions to methoxsalen, psoralen the compounds or any of the excipients.
- •patients with melanoma, cutaneous basal cell carcinoma or squamous cell coexistent.
- •Patients with aphakia.
- •Patients taking Oxoralen.
- •Pregnant women or nursing mothers, or adults of childbearing age not using effective contraception.
- •Participation in another clinical trial.
- •Inability to understand informed consent.
结局指标
主要结局
adverse event rate and rate of transplant rejection
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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