NCT02090621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

September 19, 2013

Last Update Submit

March 11, 2015

Conditions

Hepatic Insufficiency

Keywords

LivertransplantationImmunosuppressionphotopheresisextracorporeal

Outcome Measures

Primary Outcomes (3)

  • Serious Adverse Events associated with the procedure

    12 months

  • Non Serious Adverse Events

    12 months

  • Allograft Rejection

    12 months

Secondary Outcomes (5)

  • Immunosuppressant level

    12 months

  • Liver function test

    12 months

  • Renal Function test

    12 months

  • Hematological Parameters

    12 months

  • Immunological evaluation

    12 months

Study Arms (1)

Extracorporeal Photopheresis

EXPERIMENTAL

Extracorporeal Photopheresis

Procedure: Extracorporeal photopheresis

Interventions

Extracorporeal photopheresisPROCEDURE

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.

Extracorporeal Photopheresis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose Antonio Pons, MD

Murcia, El Palmar, 30120, Spain

Location

Related Publications (3)

  • 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.

    PMID: 12698096BACKGROUND

  • 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.

    PMID: 19210687BACKGROUND

  • 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.

    PMID: 19034005BACKGROUND

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PUVA TherapyUltraviolet TherapyPhototherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Jose Antonio Pons, MD

    Hospital Clínco Universitario Virgen de la Arrixaca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

March 18, 2014

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

March 1, 2015

Last Updated

March 12, 2015

Record last verified: 2014-03

Locations

ES(1)