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OpenTrials
Completed

NCT Number: NCT01428700

Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Specimens derived from subjects enrolled in the ITN030ST study.
  • Availability of adequate biopsy specimens with corresponding blood and/or serum collected within a 10 day window of a for-cause or protocol biopsy.

Exclusion criteria

  • Withdrawal of consent for the ITN030ST study.
  • Absence of consent in the ITN030ST study for the collection and storage of samples of blood and tissue for future research studies.

Treatment and study plan

Primary outcomes

  1. Expression levels of mRNA and miRNA in peripheral blood cells, serum, and tissue at the time of for cause and protocol biopsies, and the diagnostic effectiveness of identified patterns

    Time frame: +/- 10 day window from time of clinically indicated biopsy

    This assay study will analyze expression levels of mRNA and miRNA from NINV and HCV liver biopsy, whole blood, and/or serum samples from the ITN030ST study obtained within a +/- 10-day window of the biopsy.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Clinical Trials in Organ Transplantation

Registry information

Official study title

Development of Gene Expression Signatures for the Diagnosis of Liver Allograft Rejection and Recurrent Hepatitis C Disease (CTOT-07)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2011
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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