Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01428700
First received: September 1, 2011
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition
Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Development of Gene Expression Signatures for the Diagnosis of Liver Allograft Rejection and Recurrent Hepatitis C Disease (CTOT-07)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Liver tissue, whole blood, and serum specimens


Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-Immune/Non-Viral (NINV)
Patients enrolled in ITN030ST transplanted for liver failure resulting from non-viral, non-immune causes
Hepatitis C Virus (HCV) positive
Patients enrolled in ITN030ST transplanted for liver failure resulting from HCV genotype 1 infection

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients enrolled in ITN030ST (NCT00135694)

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01428700

Sponsors and Collaborators
Clinical Trials in Organ Transplantation
Investigators
Principal Investigator: Abraham Shaked, MD, PhD University of Pennsylvania
Study Chair: Manikkam Suthanthiran, MD Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01428700     History of Changes
Other Study ID Numbers: DAIT CTOT-07
Study First Received: September 1, 2011
Last Updated: February 13, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014