Extracorporeal Photopheresis After Liver Transplant

Phase 2

Completed

• Conditions: Hepatic Insufficiency

• Registration Number: NCT02090621
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-09-19
• Primary Completion: 2013-10
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Non Serious Adverse Events	12 months
Allograft Rejection	12 months
Serious Adverse Events associated with the procedure	12 months

Secondary Outcome Measures

Name	Time	Method
Renal Function test	12 months	Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance
Immunosuppressant level	12 months	CyA, tacrolimus levels
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
Liver function test	12 months	Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index.
Hematological Parameters	12 months	Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes.; Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol.

Trial Locations

Locations (1)

Jose Antonio Pons, MD; 🇪🇸 Murcia, El Palmar, Spain