Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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.