Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-Immune/Non-Viral (NINV)

Patients enrolled in ITN030ST transplanted for liver failure resulting from non-viral, non-immune causes

No interventions assigned to this group

Hepatitis C Virus (HCV) positive

Patients enrolled in ITN030ST transplanted for liver failure resulting from HCV genotype 1 infection

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No