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

Study Overview
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Brief Summary
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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.

Official Title
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FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN

Conditions
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Liver Transplantation, Immunosuppression

Intervention / Treatment
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* Procedure: Extracorporeal Photopheresis Procedure (FEC)


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: People with liver transplantation<br>People with liver transplantation over 2 years following treatment with immunosuppression including cyclosporine or tacrolimus. | Procedure: Extracorporeal Photopheresis Procedure (FEC)<br>* The FEC will be held in the Cellex (Therakos), and authorized device in routine use in our unit for performing FEC in the treatment of graft-versus-host and cutaneous T-cell lymphoma. After performing a blood count, will connect the patient to Cellex through a central or peripheral. 1500 mL typically be processed peripheral blood mononuclear fraction obtained by apheresis process. Then be added Uvadex (8-metoxipsolareno, 0.017 mL / mL) to the mononuclear fraction bag and proceed to photoactivation with UVA radiation. Finally the photoactivated product is again infuse the patient. It will monitor the final blood count to assess hemoglobin and platelets. The entire procedure is performed in a single step and closed mode, with Cellex.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event rate and rate of transplant rejection |  | 1 year |