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Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients

NCT00105235 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2012-12-27

Study results available
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Summary

Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a drug used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected. This study will determine whether treatment with alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.

Conditions

Interventions

DRUG

Alemtuzumab

T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4

DRUG

Cyclosporine

Oral immunosuppressant

DRUG

Mycophenolate mofetil

Oral immunosuppressant

DRUG

Tacrolimus

Oral immunosuppressant

PROCEDURE

Liver transplant

Occurs at study entry

PROCEDURE

Immunosuppression withdrawal

Beginning no earlier than Year 1

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • J. Richard Thistlethwaite, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-03-31
Completion
2011-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT00105235 on ClinicalTrials.gov