MedTrace Logo

Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

NCT01428700 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 275

Last updated 2023-03-22

No results posted yet for this study

Summary

Acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. Acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated when compared to baseline. The only means of differentiating acute rejection from other liver pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it may be difficult to distinguish acute rejection from another disease process, such as injury caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver transplant recipient can be used to determine if the transplanted liver is being rejected by the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute rejection and informative of the severity of HCV recurrence could allow for modulation of immunosuppression therapy and treat the clinical condition without the need for invasive liver biopsies.

Conditions

  • Liver Transplantation

Sponsors & Collaborators

  • Clinical Trials in Organ Transplantation

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Abraham Shaked, MD, PhD · University of Pennsylvania

  • Manikkam Suthanthiran, MD · Cornell University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-01-31
Completion
2013-01-31

More Related Trials

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 NCT01428700 on ClinicalTrials.gov