Extracorporeal Photopheresis After Liver Transplant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Extracorporeal Photopheresis After Liver Transplant. Phase II Clinical Trial on Safety and Efficacy in Patients With Progressive Withdrawal of Immunosuppression

Conditions
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Hepatic Insufficiency

Intervention / Treatment
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* Procedure: Extracorporeal photopheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extracorporeal Photopheresis<br>Extracorporeal Photopheresis | Procedure: Extracorporeal photopheresis<br>* Extracorporeal photopheresis with Methoxsalen(UVADEX)and immunosuppression reduction Extracorporeal photopheresis (ECP) is an immunomodulatory excellent technical tolerated initially designed for the treatment of cutaneous T-cell lymphoma and various autoimmune diseases, which has been proven effective in reversing episodes acute heart transplants, kidney and lung rejection, and in the treatment of Disease graft versus host both acute and chronic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events associated with the procedure |  | 12 months | 
| Non Serious Adverse Events |  | 12 months | 
| Allograft Rejection |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunosuppressant level | CyA, tacrolimus levels | 12 months | 
| Liver function test | Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index. | 12 months | 
| Renal Function test | Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance | 12 months | 
| Hematological Parameters | Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol. | 12 months | 
| Immunological evaluation | Study of the evolution of subpopulations of blood mononuclear cells peripheral (T cells, B cells and dendritic cells) During removal of the SI measured by flow cytometry of different lymphocyte populations and are expressed as% and / or item # cells / L blood | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver, transplantation, Immunosuppression, photopheresis, extracorporeal