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

NCT02602847 | Completed

• 1 other identifier: 2012.720
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Liver Transplantation

Keywords

Liver transplantation; HBV; cccDNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between cccDNA rate and serologic status

  1 year after transplantation

• Correlation between cccDNA rate and virologic status

  1 year after transplantation

• Correlation between cccDNA rate and patient's treatment

  1 year after transplantation

Study Arms (3)

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

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

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

Interventions

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

HBV patients; Hepatitis B core antibody positive donors; Patients with alcoholic or hepatitis C virus related disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver transplantation planned

You may qualify if:

• 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

You may not qualify if:

• Patient covered by any measure of legal protection
• informed consent not signed

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

CHU Grenoble

La Tronche, 38700, France

Location

Service d'Hépatologie, Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Hôpital Saint Eloi

Montpellier, 34295, France

Location

CHU de Nice

Nice, 06202, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

Related Publications (2)

• Testoni B, Scholtes C, Plissonnier ML, Paturel A, Berby F, Facchetti F, Villeret F, Degasperi E, Scott B, Hamilton A, Heil M, Lampertico P, Levrero M, Zoulim F. Quantification of circulating HBV RNA expressed from intrahepatic cccDNA in untreated and NUC treated patients with chronic hepatitis B. Gut. 2024 Mar 7;73(4):659-667. doi: 10.1136/gutjnl-2023-330644.

  PMID: 37879886 DERIVED

• Villeret F, Lebosse F, Radenne S, Samuel D, Roche B, Mabrut JY, Leroy V, Pageaux GP, Anty R, Thevenon S, Ahmed SS, Hamilton A, Heil M, Scholtes C, Levrero M, Testoni B, Zoulim F; ECOGREFFE Study Group. Early intrahepatic recurrence of HBV infection in liver transplant recipients despite antiviral prophylaxis. JHEP Rep. 2023 Mar 10;5(6):100728. doi: 10.1016/j.jhepr.2023.100728. eCollection 2023 Jun.

  PMID: 37122357 DERIVED

Study Officials

• Fabien ZOULIM, MD, PhD

  Service d'Hépatologie, Hôpital Croix-Rousse, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2012
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

FR (5)