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Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

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ClinicalTrials.gov Identifier: NCT01428700
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Liver Transplantation

Study Design

Study Type : Observational
Actual Enrollment : 275 participants
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)
Study Start Date : August 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and 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

Outcome Measures

Primary Outcome Measures :
  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.

Biospecimen Retention:   Samples With DNA
Liver tissue, whole blood, and serum specimens

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in ITN030ST (NCT00135694)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428700

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Principal Investigator: Abraham Shaked, MD, PhD University of Pennsylvania
Study Chair: Manikkam Suthanthiran, MD Cornell University
More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01428700     History of Changes
Other Study ID Numbers: DAIT CTOT-07
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

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