Hepatic Insufficiency Clinical Trial
Official title:
Extracorporeal Photopheresis After Liver Transplant. Phase II Clinical Trial on Safety and Efficacy in Patients With Progressive Withdrawal of Immunosuppression
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 donĀ“t use a effective anticonception method - Involved in other assay. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Jose Antonio Pons, MD | Murcia | El Palmar |
Lead Sponsor | Collaborator |
---|---|
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
Spain,
Pons JA, Ramírez P, Revilla-Nuin B, Pascual D, Baroja-Mazo A, Robles R, Sanchez-Bueno F, Martinez L, Parrilla P. Immunosuppression withdrawal improves long-term metabolic parameters, cardiovascular risk factors and renal function in liver transplant patients. Clin Transplant. 2009 Jun-Jul;23(3):329-36. doi: 10.1111/j.1399-0012.2008.00944.x. Epub 2009 Feb 5. — View Citation
Pons JA, Revilla-Nuin B, Baroja-Mazo A, Ramírez P, Martínez-Alarcón L, Sánchez-Bueno F, Robles R, Rios A, Aparicio P, Parrilla P. FoxP3 in peripheral blood is associated with operational tolerance in liver transplant patients during immunosuppression withdrawal. Transplantation. 2008 Nov 27;86(10):1370-8. doi: 10.1097/TP.0b013e318188d3e6. — View Citation
Pons JA, Yélamos J, Ramírez P, Oliver-Bonet M, Sánchez A, Rodríguez-Gago M, Navarro J, Bermejo J, Robles R, Parrilla P. Endothelial cell chimerism does not influence allograft tolerance in liver transplant patients after withdrawal of immunosuppression. Transplantation. 2003 Apr 15;75(7):1045-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serious Adverse Events associated with the procedure | 12 months | Yes | |
Primary | Non Serious Adverse Events | 12 months | Yes | |
Primary | Allograft Rejection | 12 months | Yes | |
Secondary | Immunosuppressant level | CyA, tacrolimus levels | 12 months | No |
Secondary | Liver function test | Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index. | 12 months | Yes |
Secondary | Renal Function test | Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance | 12 months | Yes |
Secondary | Hematological Parameters | Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol. |
12 months | Yes |
Secondary | 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 | No |
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