Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (OPTIMAL)

Last updated: February 16, 2016
Sponsor: NIAID
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

TX141786
  • All Genders

Study Summary

Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (OPTIMAL)

Eligibility Criteria

Inclusion

You may be eligible to participate in the OPTIMAL study if you:

  • Are 18 years of age or older
  • Received a deceased or living donor liver transplant
  • Are on tacrolimus or cyclosporine
  • Do not have a history of hepatitis C (HCV) or Human Immunodeficiency Virus (HIV)

Study Design

Study Start date:
November 20, 2015
Estimated Completion Date:

Study Description

The goal of the OPTIMAL study is to gradually reduce anti-rejection medication(s) in liver transplant recipients over a period of time until the medication(s) are stopped. This is called immunosuppression withdrawal.

As part of the OPTIMAL study, investigators will also do blood and liver biopsy tests to see whether they can identify common markers of immune systems that are able to tolerate transplanted livers without immunosuppressive medications. Identification of these markers and tests will help transplant doctors predict whether it is safe to decrease or stop anti-rejection medication(s) for future liver transplant recipients.

In general, study visits will consist of a brief physical exam, and some visits will also include questionnaires as well as blood, urine, stool (fecal), and liver biopsy collections.

In total, participation may last between 3.5 and 6 years.

For more information, visit www.optimalstudy.org

For more information, visit www.optimalstudy.org

Connect with a study center

  • University of California, San Francisco Medical Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Northwestern Memorial University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Massachusetts General Hospital – Transplant Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Columbia Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • UPMC Montefiore, 7 South 

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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