Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
This trial is active, not recruiting.
|Conditions||liver transplantation, immunosuppression|
|Treatment||extracorporeal photopheresis procedure (fec)|
|Phase||phase 1/phase 2|
|Sponsor||Red de Terapia Celular|
|Collaborator||Spanish National Health System|
|Start date||April 2013|
|End date||June 2016|
|Trial size||10 participants|
|Trial identifier||NCT01824368, 2012-000633-39, FEC-TH|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
adverse event rate and rate of transplant rejection
time frame: 1 year
Male or female participants at least 18 years old.
- 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.
- 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.
|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|
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