Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428700
• Other study ID #: DAIT CTOT-07
• Status: Completed
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2023
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• Liver Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	+/- 10 day window from time of clinically indicated biopsy

External Links

•   Clinical Trials in Organ Transplantation (CTOT)
•   National Institute of Allergy and Infectious Diseases (NIAID)