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

Phase 1

Completed

• Conditions: Liver Transplantation; Immunosuppression
• Interventions: Procedure: Extracorporeal Photopheresis Procedure (FEC)

• Registration Number: NCT01824368
• Lead Sponsor: Red de Terapia Celular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-04
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
People with liver transplantation	Extracorporeal Photopheresis Procedure (FEC)	People with liver transplantation over 2 years following treatment with immunosuppression including cyclosporine or tacrolimus.

Primary Outcome Measures

Name	Time	Method
adverse event rate and rate of transplant rejection	1 year

Trial Locations

Locations (1)

University Hospital Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain