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Completed

NCT Number: NCT02602847

Study of Covalently Closed Circular DNA (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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble, La Tronche, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cccDNA assay on liver biopsy

Biological

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Study of cccDNA in Liver Transplant Patients With B Virus Markers

Acronym: ECOGREFFE-B

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2015
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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