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

Liver Transplantation Clinical Trial

— ECOGREFFE-B  

Official title:

Study of cccDNA in Liver Transplant Patients With B Virus Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602847
• Other study ID #: 2012.720
• Status: Completed
• Start date: November 2012
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
France	CHU Grenoble	La Tronche
France	Service d'Hépatologie, Hôpital de la Croix-Rousse	Lyon
France	Hôpital Saint Eloi	Montpellier
France	CHU de Nice	Nice
France	Hôpital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy	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	Correlation between cccDNA rate and serologic status	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
Secondary	Correlation between cccDNA rate and virologic status	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
Secondary	Correlation between cccDNA rate and patient's treatment	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