Clinical trial NCT02090621: Extracorporeal Photopheresis After Liver Transplant
Official title: Extracorporeal Photopheresis After Liver Transplant. Phase II Clinical Trial on Safety and Efficacy in Patients With Progressive Withdrawal of Immunosuppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatic Insufficiency
Keywords: Liver
transplantation
Immunosuppression
photopheresis
extracorporeal
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serious Adverse Events associated with the procedure
timeFrame: 12 months
measure: Non Serious Adverse Events
timeFrame: 12 months
measure: Allograft Rejection
timeFrame: 12 months
Secondary outcomes:
measure: Immunosuppressant level
timeFrame: 12 months
measure: Liver function test
timeFrame: 12 months
measure: Renal Function test
timeFrame: 12 months
measure: Hematological Parameters
timeFrame: 12 months
measure: Immunological evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Jose Antonio Pons, MD
state: El Palmar
Study officials:
affiliation: Hospital Clínco Universitario Virgen de la Arrixaca
name: Jose Antonio Pons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.