Overview

This trial is active, not recruiting.

Conditions hepatitis c virus, liver transplantation
Sponsor Schiano, Thomas D., MD
Collaborator Merck Sharpe & Dohme Corporation
Start date June 2013
End date December 2015
Trial size 20 participants
Trial identifier NCT01836718, 13-00099, MISP-50064

Summary

The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver transplantation in patients receiving antiviral therapy while on the liver transplant waiting list. This will eventually be correlated with the degree of hepatic fibrosis present within different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times in different segments of the liver and preserved for viral detection studies as well as analysis of the degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1 month, 3 months and 6 months post liver transplantation.

Study Hypotheses:

- Virological relapse or non-response is higher is patients with cirrhosis due to failure of antiviral medication to concentrate adequately in a fibrotic liver having an altered sinusoidal micro-architecture

- HCV may persist in different geographic regions of the fibrotic liver in part predicated on blood supply to that area and this may have an effect on overall virological response. These differences in viral persistence and detection may exist in different lobes of the liver or even within a few centimeters within the same portion of the liver parenchyma.

- PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in patients receiving antiviral therapy and may account for virological relapse post-therapy

- There may be varying degrees of fibrosis within the same cirrhotic liver which may impact on hepatic synthetic function and antiviral response to treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients undergoing liver transplantation who are documented HCV viral load undetectable while on antiviral therapy
Patients undergoing liver transplantation who are receiving anti-viral therapy and who have a documented detectable HCV viral load
Patients undergoing liver transplantation who are not currently receiving anti-viral therapy and are documented viral load positive will be included and serve as a comparison group

Primary Outcomes

Measure
HCV RNA PCR levels
time frame: Time of Transplantation

Secondary Outcomes

Measure
HCV persistence
time frame: Time of Transplantation
Hepatic Fibrosis
time frame: Time of Transplantation
Extrahepatic reservoirs
time frame: Time of Transplantation

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Patients age 18-80 with chronic HCV on the liver transplant waiting list may be eligible for participation - The following subjects will be enrolled: - Patients undergoing liver transplantation who are documented HCV viral load undetectable while on antiviral therapy - Patients receiving anti-viral therapy and who have a detectable HCV viral load - Patients not currently receiving antiviral therapy and are HCV PCR (+) will be included and serve as a comparison group Exclusion Criteria: - Patients who are co-infected with HIV and/or HBV will not be included

Additional Information

Official title An Assessment of Intrahepatic HCV RNA Levels at the Time of Liver Transplantation in Patients With HCV Receiving Antiviral Therapy While on the Liver Transplant Waiting List Compared to Those Not Currently Receiving Therapy
Principal investigator Thomas D Schiano, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Schiano, Thomas D., MD.