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Clinical Trials/NCT02090621
NCT02090621CompletedPhase 2

Extracorporeal Photopheresis After Liver Transplant. Phase II Clinical Trial on Safety and Efficacy in Patients With Progressive Withdrawal of Immunosuppression

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia2 sites in 1 country10 target enrollmentStarted: October 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
Non Serious Adverse Events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine the safety of photopheresis for prophylaxis of allograft rejection in patients who are being withdrawal immunosuppression after liver transplantation.

Detailed Description

The photopheresis (ECP) is a therapeutic approach based on the biological effect of ultraviolet light A on mononuclear cells collected by apheresis, and reinfused into the patient.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Liver transplantation 2 years ago
  • •>18 years
  • •Treatment with immunosuppression (Cyclosporine or tacrolimus)
  • •Normal hepatic function during last year
  • •No acute or chronic rejection
  • •to have some secondary effect because of immunosuppressors
  • •Previous disease: alcoholic liver cirrhosis with or without hepatocarcinoma, metabolic disease, amyloid polyneuropathy, hepatitis,cryptogenic cirrhosis and non autoimmune causes
  • •Signing consent informed form

Exclusion Criteria

  • •Additional liver Transplantation
  • •hypersensitivity to methoxsalen
  • •Patients with melanoma ,cutaneous carcinoma
  • •Patients with aphakia
  • •Patients treated with oxsoralen
  • •Pregnant women, lactating women or fertile adults that they don´t use a effective anticonception method
  • •Involved in other assay.

Outcomes

Primary Outcomes

Non Serious Adverse Events

Time Frame: 12 months

Allograft Rejection

Time Frame: 12 months

Serious Adverse Events associated with the procedure

Time Frame: 12 months

Secondary Outcomes

  • Renal Function test(12 months)
  • Immunosuppressant level(12 months)
  • Hematological Parameters(12 months)
  • Immunological evaluation(12 months)
  • Liver function test(12 months)

Investigators

Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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