Clinical trial NCT01824368: Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
Official title: FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Transplantation
Immunosuppression
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: Spanish National Health System
name: Universidad de Murcia
name: Hospital Universitario Virgen de la Arrixaca
name: Public Health Service, Murcia
First posted: 2013-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: adverse event rate and rate of transplant rejection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: University Hospital Virgen de la Arrixaca
state: Murcia
Study officials:
References: