search
Back to results

Extracorporeal Photopheresis After Liver Transplant

Primary Purpose

Hepatic Insufficiency

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Extracorporeal photopheresis
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Insufficiency focused on measuring Liver, transplantation, Immunosuppression, photopheresis, extracorporeal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jose Antonio Pons, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extracorporeal Photopheresis

Arm Description

Extracorporeal Photopheresis

Outcomes

Primary Outcome Measures

Serious Adverse Events associated with the procedure
Non Serious Adverse Events
Allograft Rejection

Secondary Outcome Measures

Immunosuppressant level
CyA, tacrolimus levels
Liver function test
Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index.
Renal Function test
Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance
Hematological Parameters
Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol.
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

Full Information

First Posted
September 19, 2013
Last Updated
March 11, 2015
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
search

1. Study Identification

Unique Protocol Identification Number
NCT02090621
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency
Keywords
Liver, transplantation, Immunosuppression, photopheresis, extracorporeal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal Photopheresis
Arm Type
Experimental
Arm Description
Extracorporeal Photopheresis
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal photopheresis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serious Adverse Events associated with the procedure
Time Frame
12 months
Title
Non Serious Adverse Events
Time Frame
12 months
Title
Allograft Rejection
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Immunosuppressant level
Description
CyA, tacrolimus levels
Time Frame
12 months
Title
Liver function test
Description
Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index.
Time Frame
12 months
Title
Renal Function test
Description
Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance
Time Frame
12 months
Title
Hematological Parameters
Description
Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol.
Time Frame
12 months
Title
Immunological evaluation
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Antonio Pons, MD
Organizational Affiliation
Hospital Clínco Universitario Virgen de la Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jose Antonio Pons, MD
City
Murcia
State/Province
El Palmar
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12698096
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.
Results Reference
background
PubMed Identifier
19210687
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.
Results Reference
background
PubMed Identifier
19034005
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.
Results Reference
background

Learn more about this trial

Extracorporeal Photopheresis After Liver Transplant

We'll reach out to this number within 24 hrs