Extracorporeal Photopheresis After Liver Transplant

Phase 2CompletedNCT02090621

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Insufficiency

Interventions

Extracorporeal photopheresisPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jose Antonio Pons, MD

Murcia, El Palmar, Spain

Outcomes

Primary Outcomes

Serious Adverse Events associated with the procedure

Time frame: 12 months

Non Serious Adverse Events

Time frame: 12 months

Allograft Rejection

Time frame: 12 months

Secondary Outcomes

Immunosuppressant level

CyA, tacrolimus levels

Time frame: 12 months

Liver function test

Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index.

Time frame: 12 months

Renal Function test

Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance

Time frame: 12 months

Hematological Parameters

Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol.

Time frame: 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

Time frame: 12 months

Data from ClinicalTrials.gov

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