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Assessment of Intrahepatic Hepatitis C Virus (HCV) RNA Levels at the Time of Liver Transplantation

27. januar 2017 oppdatert av: Schiano, Thomas D., MD

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

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.

Studieoversikt

Status

Ukjent

Forhold

Studietype

Observasjonsmessig

Registrering (Forventet)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- New York
  - New York, New York, Forente stater, 10029
    - Mount Sinai School of Medicine Recanati/Miller Transplantation Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patients with Chronic Hepatitis C on the Mount Sinai Recanati/Miller Transplantation Institute's Liver Transplant Waiting list may be eligible for participation

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
HCV RNA PCR levels Tidsramme: Time of Transplantation	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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
HCV persistence Tidsramme: Time of Transplantation	To ascertain whether HCV persistence within the liver is predictive of virological relapse post liver transplantation.	Time of Transplantation
Hepatic Fibrosis Tidsramme: Time of Transplantation	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.	Time of Transplantation
Extrahepatic reservoirs Tidsramme: Time of Transplantation	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Schiano, Thomas D., MD

Samarbeidspartnere

Merck Sharp & Dohme LLC

Icahn School of Medicine at Mount Sinai

Etterforskere

Hovedetterforsker: Thomas D Schiano, MD, Mount Sinai School of Medicine Recanati/Miller Transplantation Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2013

Primær fullføring (Forventet)

1. desember 2017

Studiet fullført (Forventet)

1. juni 2018

Datoer for studieregistrering

Først innsendt

17. april 2013

Først innsendt som oppfylte QC-kriteriene