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Completed

NCT Number: NCT02090621

Extracorporeal Photopheresis After Liver Transplant

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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jose Antonio Pons, MD

Murcia, El Palmar, 30120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Photopheresis

Procedure

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 outcomes

  1. Serious Adverse Events associated with the procedure

    Time frame: 12 months

  2. Non Serious Adverse Events

    Time frame: 12 months

  3. Allograft Rejection

    Time frame: 12 months

Secondary outcomes

  1. Immunosuppressant level

    Time frame: 12 months

    CyA, tacrolimus levels

  2. Liver function test

    Time frame: 12 months

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

  3. Renal Function test

    Time frame: 12 months

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

  4. Hematological Parameters

    Time frame: 12 months

    Basic hematological parameters:

    Hemoglobin, hematocrit, platelets and leukocytes.

    Metabolic parameters:

    Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol.

  5. Immunological evaluation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Extracorporeal Photopheresis After Liver Transplant. Phase II Clinical Trial on Safety and Efficacy in Patients With Progressive Withdrawal of Immunosuppression

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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