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Completed

NCT Number: NCT01824368

Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.
  • It is necessary that the patient meets all inclusion criteria.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. adverse event rate and rate of transplant rejection

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Red de Terapia Celular

Industry

Collaborators

  • Hospital Universitario Virgen de la Arrixaca
  • Public Health Service, Murcia
  • Spanish National Health System
  • Universidad de Murcia

Registry information

Official study title

FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN

Acronym: FEC-TH

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2013
Registry last updated
Mar 30, 2017

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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