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

27. januar 2017 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine Recanati/Miller Transplantation Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Schiano, Thomas D., MD

Samarbejdspartnere

Merck Sharp & Dohme LLC
Icahn School of Medicine at Mount Sinai

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2013

Primær færdiggørelse (Forventet)

1. december 2017

Studieafslutning (Forventet)

1. juni 2018

Datoer for studieregistrering

Først indsendt

17. april 2013

Først indsendt, der opfyldte QC-kriterier

17. april 2013

Først opslået (Skøn)

22. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MISP-50064
  • 13-00099 (Anden identifikator: Mount Sinai PPHS)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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