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

27 janvier 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Type d'étude

Observationnel

Inscription (Anticipé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- New York
  - New York, New York, États-Unis, 10029
    - Mount Sinai School of Medicine Recanati/Miller Transplantation Institute

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
HCV RNA PCR levels Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
HCV persistence Délai: Time of Transplantation	To ascertain whether HCV persistence within the liver is predictive of virological relapse post liver transplantation.	Time of Transplantation
Hepatic Fibrosis Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Schiano, Thomas D., MD

Collaborateurs

Merck Sharp & Dohme LLC

Icahn School of Medicine at Mount Sinai

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2013

Achèvement primaire (Anticipé)

1 décembre 2017

Achèvement de l'étude (Anticipé)

1 juin 2018

Dates d'inscription aux études

Première soumission

17 avril 2013

Première soumission répondant aux critères de contrôle qualité