Extracorporeal photopheresis in liver transplantation. Clinical trial phase I/II safety and efficacy in patients with progressive withdrawal of immunosuppression. - FEC-TH

Fundación para la Formación e Investigación Sanitaria0 个研究点开始时间: 2012年3月6日最近更新: 2012年5月29日

适应症

试验速览

暂无简介。

•- Have been receiving liver transplant for over two years.
•- Treatment with immunosuppression that includes cyclosporine or tacrolimus.
•- Have a normal liver function in the last year
•- Not have suffered acute rejection in the last year and have no chronic rejection
•- Present any significant side effects of immunosuppressive medication (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity, de novo malignancy, etc)
•- Etiology of underlying disease: alcoholic cirrhosis with or without hepatocellular carcinoma, metabolic diseases, familial amyloid polyneuropathy, biliary atresia, fulminant hepatitis non-A, not B, not C, cryptogenic cirrhosis and in general, non-autoimmune and viral causes.
•- Patients who offer sufficient guarantees of adherence to protocol
•? Patients who give written informed consent to participate in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•- Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) and hepatocellular carcinoma in viral cirrhosis or autoimmune.
•- Patients with chronic rejection, or acute rejection in the last year
•- Patients with liver retransplantation
•- Inability to understand informed consent.

发起方

Fundación para la Formación e Investigación Sanitaria