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| ID | Type | Description | Link |
|---|---|---|---|
| 13-00099 | Other Identifier | Mount Sinai PPHS |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Icahn School of Medicine at Mount Sinai | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV RNA (-) on anti-viral therapy | Patients undergoing liver transplantation who are documented HCV viral load undetectable while on antiviral therapy | ||
| HCV RNA (+) on anti-viral therapy | Patients undergoing liver transplantation who are receiving anti-viral therapy and who have a documented detectable HCV viral load | ||
| HCV RNA (+) not on anti-viral therapy | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA PCR levels | The primary objective is to detect and quantitate HCV RNA PCR levels in different anatomic regions of the liver at the time of liver transplantation to ascertain whether there is similar geographic presence and/or clearance of HCV during antiviral therapy | Time of Transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| HCV persistence | To ascertain whether HCV persistence within the liver is predictive of virological relapse post liver transplantation. | Time of Transplantation |
| Hepatic Fibrosis | To assess the degree of hepatic fibrosis at the site of intrahepatic HCV viral detection in order to ascertain whether HCV viral detection correlates with the degree of fibrosis. This study will also examine whether there can be different degrees of hepatic fibrosis in different geographic portions of the same liver and whether there would be a correlation with the patients' natural MELD score, degree of hepatic synthetic function and ultimate virological response to antiviral therapy. |
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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:
Exclusion Criteria:
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Patients with Chronic Hepatitis C on the Mount Sinai Recanati/Miller Transplantation Institute's Liver Transplant Waiting list may be eligible for participation
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| Name | Affiliation | Role |
|---|---|---|
| Thomas D Schiano, MD | Mount Sinai School of Medicine Recanati/Miller Transplantation Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine Recanati/Miller Transplantation Institute | New York | New York | 10029 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 8, 2017 | |
| Reset | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 8, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Whole blood, serum, liver explant tissue and hilar lymph nodes will be obtained for testing. With subject consent, any unused specimens will be retained indefinitely for use in future research either related or unrelated to this study, which may include genetic testing.
| Time of Transplantation |
| Extrahepatic reservoirs | To examine whether hilar lymph nodes and PBMC are extrahepatic reservoirs of HCV in patients receiving antiviral therapy and then to correlate this with intrahepatic detection of HCV and overall virological response. | Time of Transplantation |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |