Extracorporeal Photopheresis After Liver Transplant

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02090621
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 28.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency	Procedure: Extracorporeal photopheresis	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extracorporeal Photopheresis After Liver Transplant. Phase II Clinical Trial on Safety and Efficacy in Patients With Progressive Withdrawal of Immunosuppression
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Extracorporeal Photopheresis Extracorporeal Photopheresis

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.

Outcome Measures

Primary Outcome Measures

1. Serious Adverse Events associated with the procedure [12 months]

2. Non Serious Adverse Events [12 months]

3. Allograft Rejection [12 months]

Secondary Outcome Measures

1. Immunosuppressant level [12 months]

   CyA, tacrolimus levels

2. Liver function test [12 months]

   Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index.

3. Renal Function test [12 months]

   Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance

4. Hematological Parameters [12 months]

   Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol.

5. Immunological evaluation [12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jose Antonio Pons, MD	Murcia	El Palmar	Spain	30120

Sponsors and Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Investigators

• Principal Investigator: Jose Antonio Pons, MD, Hospital Clínco Universitario Virgen de la Arrixaca

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• ClinicalTrials.gov Identifier: NCT02090621
• Other Study ID Numbers: FEC-TH; 2012-000633-39
• First Posted: Mar 18, 2014
• Last Update Posted: Mar 12, 2015
• Last Verified: Mar 1, 2014

• Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: Liver; transplantation; Immunosuppression; photopheresis; extracorporeal
• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure

Study Results

No Results Posted as of Mar 12, 2015