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

January 10, 2019 updated by: Hospices Civils de Lyon

Study of cccDNA in Liver Transplant Patients With B Virus Markers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • Chu Grenoble
      • Lyon, France, 69004
        • Service d'Hépatologie, Hôpital de la Croix-Rousse
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nice, France, 06202
        • Chu de Nice
      • Villejuif, France, 94804
        • Hopital Paul Brousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with liver transplantation planned

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after transplantation
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
1 year after transplantation
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
1 year after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Fabien ZOULIM, MD, PhD, Service d'Hépatologie, Hôpital Croix-Rousse, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012.720

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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