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Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial

NCT00436722 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2009-05-20

No results posted yet for this study

Summary

This is a randomized, controlled trial in liver transplantation in which conventional immunosuppressive treatment will be compared with a therapeutic strategy consisting in pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor minimization may promote development of tolerogenic mechanisms allowing the eventual withdrawal of all immunosuppressive therapy.

Conditions

Interventions

DRUG

ATG (Fresenius Biotech)

ATG-Fresenius 9 mg/kg at induction

Sponsors & Collaborators

  • Fresenius AG

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Alberto Sanchez-Fueyo · Hospital Clinic Barcelona, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00436722 on ClinicalTrials.gov