Status:
COMPLETED
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
Lead Sponsor:
Red de Terapia Celular
Collaborating Sponsors:
Spanish National Health System
Universidad de Murcia
Conditions:
Liver Transplantation
Immunosuppression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01824368
Start Date
April 1 2013
End Date
April 1 2016
Last Update
March 30 2017
Active Locations (1)
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1
University Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120