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Study of Covalently Closed Circular DNA (cccDNA) in Liver Transplant Patients With B Virus Markers (ECOGREFFE-B)

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ClinicalTrials.gov Identifier: NCT02602847
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
The aim of this study is to validate in the context of liver transplantation, the interest of the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver through several groups of patients at transplantation (on graft and native liver explant) and after transplantation.

Condition or disease Intervention/treatment
Liver Transplantation Biological: cccDNA assay on liver biopsy

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of cccDNA in Liver Transplant Patients With B Virus Markers
Study Start Date : November 2012
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with alcoholic or hepatitis C virus related disease
cccDNA assay on liver biopsy in patients with liver transplantation for alcoholic disease or hepatitis C virus (HCV) related disease, without contact with HBV
Biological: cccDNA assay on liver biopsy
cccDNA assay will be performed on liver biopsies at different times : During transplantation : Liver biopsy of explant and graft and virological biology Between M1 to M3 after transplantation : Liver biopsy between 1 to 3 months after transplantation M12 : Liver biopsy 12 months after transplantation

Hepatitis B core antibody positive donors
cccDNA assay on liver biopsy in patients who receive liver from hepatitis B core antibody positive donors
Biological: cccDNA assay on liver biopsy
cccDNA assay will be performed on liver biopsies at different times : During transplantation : Liver biopsy of explant and graft and virological biology Between M1 to M3 after transplantation : Liver biopsy between 1 to 3 months after transplantation M12 : Liver biopsy 12 months after transplantation

HBV patients
cccDNA assay on liver biopsy in patient with liver transplantation for chronic hepatitis B, with or without HBV replication
Biological: cccDNA assay on liver biopsy
cccDNA assay will be performed on liver biopsies at different times : During transplantation : Liver biopsy of explant and graft and virological biology Between M1 to M3 after transplantation : Liver biopsy between 1 to 3 months after transplantation M12 : Liver biopsy 12 months after transplantation




Primary Outcome Measures :
  1. cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy [ Time Frame: 1 year after transplantation ]
    cccDNA rate will be assessed on native explant and liver transplant during transplantation and on liver biopsy (between M1 to M3 and 12 months (M12) after transplantation) to study the colonization of new hepatocytes by HBV


Secondary Outcome Measures :
  1. Correlation between cccDNA rate and serologic status [ Time Frame: 1 year after transplantation ]
    Correlation of cccDNA rate with serologic and virologic status (AgHBe, HBV DNA, ...) at the moment of the transplantation and during post-transplantation period and HBV recurrence

  2. Correlation between cccDNA rate and virologic status [ Time Frame: 1 year after transplantation ]
    Correlation of cccDNA assay with serologic and virologic status (AgHBe, HBV DNA, ...) will be assessed at the moment of the transplantation and during post-transplantation period and HBV recurrence

  3. Correlation between cccDNA rate and patient's treatment [ Time Frame: 1 year after transplantation ]
    Correlation of cccDNA rate with patients' treatments will be assessed at the moment of the transplantation and during post-transplantation period and HBV recurrence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with liver transplantation planned
Criteria

Inclusion Criteria:

  • Patient registered on the national Organ Transplant Waiting List for liver transplantation
  • Indication of transplantation :
  • Alcoholic related disease without serum anti-hepatitis B core antibody (HBc) (less than 4 weeks) OR - HCV related disease without serum anti-HBc antibody (less than 4 weeks) OR - Patients who sign consent for liver transplantation from hepatitis B core antibody positive donors OR - HBV related disease with positive serum HBs antigen (with or without HBV replication measured by polymerase chain reaction (PCR) within 6 months prior transplantation)
  • Signed consent form
  • Patient with a social cover
  • Patient not covered by any measure of legal protection

Exclusion Criteria:

  • Co-infection with HIV, hepatitis delta virus (HDV), HBV (for control arm), HCV (for Test arm) - Positive serology within the4 weeks before inclusion
  • Patient covered by any measure of legal protection
  • informed consent not signed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602847


Locations
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France
CHU Grenoble
La Tronche, France, 38700
Service d'Hépatologie, Hôpital de la Croix-Rousse
Lyon, France, 69004
Hôpital Saint Eloi
Montpellier, France, 34295
CHU de Nice
Nice, France, 06202
Hôpital Paul Brousse
Villejuif, France, 94804
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Fabien ZOULIM, MD, PhD Service d'Hépatologie, Hôpital Croix-Rousse, Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02602847     History of Changes
Other Study ID Numbers: 2012.720
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Keywords provided by Hospices Civils de Lyon:
Liver transplantation
HBV
cccDNA

Additional relevant MeSH terms:
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Liver Extracts
Hematinics