Extracorporeal Photopheresis After Liver Transplant

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

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 don´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

• Hepatic Insufficiency

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