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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02602847
• Collaborator: (none)
• Enrollment: 40
• Locations: 5
• Duration (Months): 72
• Patients Per Site: 8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
Liver Transplantation	Biological: cccDNA assay on liver biopsy

Study Design

• 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: Nov 1, 2012
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Grenoble	La Tronche		France	38700
2	Service d'Hépatologie, Hôpital de la Croix-Rousse	Lyon		France	69004
3	Hôpital Saint Eloi	Montpellier		France	34295
4	CHU de Nice	Nice		France	06202
5	Hôpital Paul Brousse	Villejuif		France	94804

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02602847
• Other Study ID Numbers: 2012.720
• First Posted: Nov 11, 2015
• Last Update Posted: Jan 11, 2019
• Last Verified: Jan 1, 2019

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

Study Results

No Results Posted as of Jan 11, 2019