Liver transplantation more than 2 years of evolution to complications of immunosuppression.
Conditions
Interventions
Trade Name: Uvadex 20microgramos /ml
Pharmaceutical Form: Solution for blood fraction modification
CAS Number: 298-81-7
Other descriptive name: METHOXSALEN
Concentration unit: µg microgram(s)
Concentr
Sponsors
Fundación para la Formación e Investigación Sanitaria
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Assess along the process of withdrawal of immunosuppression and FEC differences between patients who tolerate the graft and not in terms of: - Immunophenotype in peripheral blood of different Treg cell subsets, B Reg and dendritic cells. - Cytokines Th1/Th2/Th17.;Primary end point(s): - Absence of serious adverse events regarding possible, probable or definite with the procedure. - Rate of non-serious adverse events. - No signs of acute or chronic rejection.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical assessment:Liver function,levels of immunosuppressive,basic hematological parameters,metabolic parameters,renal function parameters. - Evaluation immune:Study of the evolution of subpopulations of peripheral blood mononuclear cells (T cells, B cells and dendritic cells),study of the evolution of cytokines in peripheral blood along the withdrawal of the SI (pg / ml). - Histological evaluation:Liver biopsies.;Timepoint(s) of evaluation of this end point: - Clinical assessment:Liver function,levels of immunosuppressive,basic hematological parameters,metabolic parameters,renal function parameters.Evaluate:We Will take place on day 0, after 15 days and monthly up to 1 year. - Evaluation immune:Study of the evolution of subpopulations of peripheral blood mononuclear cells (T cells, B cells and dendritic cells),study of the evolution of cytokines in peripheral blood along the withdrawal of the SI (pg / ml).Evaluate:We Will take place on day 0, after 15 days and monthly up to 1 year. - Histological evaluation:Liver biopsies.Evaluate:There will be two months after withdrawal of immunosuppression and when clinically appropriate according to the protocol. | — |
Countries
Spain
Contacts
Public ContactMacarena Quesada Rojas
Fundación para Formación e Investigación Sanitaria
Outcome results
None listed