Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2012-10-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Extracorporeal Photopheresis
Extracorporeal Photopheresis
Extracorporeal photopheresis
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.
Interventions
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Extracorporeal photopheresis
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 Criteria
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Inclusion Criteria
* \>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
* 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.
18 Years
ALL
No
Sponsors
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
OTHER
Responsible Party
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Principal Investigators
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Jose Antonio Pons, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínco Universitario Virgen de la Arrixaca
Locations
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Jose Antonio Pons, MD
Murcia, El Palmar, Spain
Countries
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References
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Pons JA, Yelamos J, Ramirez P, Oliver-Bonet M, Sanchez A, Rodriguez-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. doi: 10.1097/01.TP.0000058472.71775.7D.
Pons JA, Ramirez 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.
Pons JA, Revilla-Nuin B, Baroja-Mazo A, Ramirez P, Martinez-Alarcon L, Sanchez-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.
Other Identifiers
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2012-000633-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FEC-TH
Identifier Type: -
Identifier Source: org_study_id
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