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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02090621
Other study ID # FEC-TH
Secondary ID 2012-000633-39
Status Completed
Phase Phase 2
First received September 19, 2013
Last updated March 11, 2015
Start date October 2012
Est. completion date March 2015

Study information

Verified date March 2014
Source Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Spain Jose Antonio Pons, MD Murcia El Palmar

Sponsors (1)

Lead Sponsor Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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

Outcome

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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