NCT01824368

Brief Summary

The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.

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_1

Timeline
Completed

Started Apr 2013

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

April 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 30, 2017

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

April 1, 2013

Last Update Submit

March 29, 2017

Conditions

Liver TransplantationImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • adverse event rate and rate of transplant rejection

    1 year

Study Arms (1)

People with liver transplantation

EXPERIMENTAL

People with liver transplantation over 2 years following treatment with immunosuppression including cyclosporine or tacrolimus.

Procedure: Extracorporeal Photopheresis Procedure (FEC)

Interventions

Extracorporeal Photopheresis Procedure (FEC)PROCEDURE

The FEC will be held in the Cellex (Therakos), and authorized device in routine use in our unit for performing FEC in the treatment of graft-versus-host and cutaneous T-cell lymphoma. After performing a blood count, will connect the patient to Cellex through a central or peripheral. 1500 mL typically be processed peripheral blood mononuclear fraction obtained by apheresis process. Then be added Uvadex (8-metoxipsolareno, 0.017 mL / mL) to the mononuclear fraction bag and proceed to photoactivation with UVA radiation. Finally the photoactivated product is again infuse the patient. It will monitor the final blood count to assess hemoglobin and platelets. The entire procedure is performed in a single step and closed mode, with Cellex.

People with liver transplantation

Eligibility Criteria

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

You may qualify if:

  • Have been receiving liver transplant two years ago.
  • Be 18 years or older.
  • Treatment with immunosuppression including cyclosporine or tacrolimus.
  • Having a normal liver function in the last year
  • Not have suffered acute rejection in the last year and have no chronic rejection
  • Submit any significant side effects from medication immunosuppressive (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity novo malignancy, etc.)
  • Etiology of underlying disease: alcoholic cirrhosis with or without hepatocarcinoma, metabolic diseases, amyloidotic polyneuropathy family, biliary atresia, fulminant hepatitis non-A, non-B, non-C, cirrhosis cryptogenic and generally causes no viral or autoimmune.
  • Patients offering sufficient guarantees of adherence to protocol
  • Patients who give written informed consent for participate in the study.

You may not qualify if:

  • Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) or epatocarcinoma about cirrhosis of viral or autoimmune.
  • Patients with chronic rejection, or acute rejection in the last year.
  • Patients with liver retransplantation.
  • patients with history of hypersensitivity or idiosyncratic reactions to methoxsalen, psoralen the compounds or any of the excipients.
  • patients with melanoma, cutaneous basal cell carcinoma or squamous cell coexistent.
  • Patients with aphakia.
  • Patients taking Oxoralen.
  • Pregnant women or nursing mothers, or adults of childbearing age not using effective contraception.
  • Participation in another clinical trial.
  • Inability to understand informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Related Links

MeSH Terms

Interventions

FEC protocol

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 4, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 30, 2017

Record last verified: 2016-04

Locations

ES(1)