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

  • STATUS
    Recruiting
  • sponsor
    NIAID
Updated on 23 November 2020

Summary

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

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

Details
Clinical Study IdentifierTX141786
SponsorNIAID
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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