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

Conditions: iver transplantation more than 2 years of evolution to complications of immunosuppression.
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2012-000633-39-ES

Lead Sponsor: Fundación para la Formación e Investigación Sanitaria

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the safety of extracorporeal photopheresis in patients with longstanding liver transplantation under immunosuppression withdrawal complications from the use thereof.;Secondary Objective: Evaluate the effect of extracorporeal photopheresis in the development of operational tolerance in liver transplant patients.<br><br>Assess along the process of withdrawal of immunosuppression and FEC differences between patients who tolerate the graft and not in terms of:<br><br>- Immunophenotype in peripheral blood of different Treg cell subsets, B Reg and dendritic cells.<br>- Cytokines Th1/Th2/Th17.;Primary end point(s): - Absence of serious adverse events regarding possible, probable or definite with the procedure.<br>- Rate of non-serious adverse events.<br>- No signs of acute or chronic rejection.;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures