Liver TransplantationECOGREFFE-BNCT02602847
Study of Covalently Closed Circular DNA (cccDNA) in Liver Transplant Patients With B Virus Markers
An observational study of Liver Transplantation, run by Hospices Civils de Lyon at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- cccDNA assay on liver biopsy
- How many people
- 40 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2012to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver transplantation planned
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Grenoble
La Tronche, 38700
Service d'Hépatologie, Hôpital de la Croix-Rousse
Lyon, 69004
Hôpital Saint Eloi
Montpellier, 34295
CHU de Nice
Nice, 06202
Hôpital Paul Brousse
Villejuif, 94804
About this study
Official title: 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.
- Conditions
- Liver Transplantation
- Being tested
- cccDNA assay on liver biopsy
- Keywords
- Liver transplantation, HBV, cccDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cccDNA assay on liver biopsyBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Biological: cccDNA assay on liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after transplantation
Secondary outcomes (3)
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
Measured: 1 year after transplantation
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
Measured: 1 year after transplantation
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
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2012
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien ZOULIM, MD, PhD, Principal investigator, Service d'Hépatologie, Hôpital Croix-Rousse, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602847
- Sponsor's protocol ID
- 2012.720
- Acronym
- ECOGREFFE-B
- Status last verified
- Jan 2019
- First submitted
- 5 Nov 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37879886Villeret 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.
PubMed 37122357
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of cccDNA in Liver Transplant Patients With B Virus Markers
- ClinicalTrials.gov ID
- NCT02602847
- Acronym / sponsor ID
- ECOGREFFE-B / 2012.720
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, HBV, cccDNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with alcoholic or hepatitis C virus related disease | – | Biological: cccDNA assay on liver biopsycccDNA assay on liver biopsy in patients with liver transplantation for alcoholic disease or hepatitis C virus (HCV) related disease, without contact with HBV |
| Hepatitis B core antibody positive donors | – | Biological: cccDNA assay on liver biopsycccDNA assay on liver biopsy in patients who receive liver from hepatitis B core antibody positive donors |
| HBV patients | – | Biological: cccDNA assay on liver biopsycccDNA assay on liver biopsy in patient with liver transplantation for chronic hepatitis B, with or without HBV replication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver transplantation planned
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cccDNA assay on liver biopsycccDNA 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 | Biological | HBV patients, Hepatitis B core antibody positive donors, Patients with alcoholic or hepatitis C virus related disease |
Primary outcome
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
3 secondary outcomes
Correlation between cccDNA rate and serologic status
Time frame: 1 year after transplantation
Correlation between cccDNA rate and virologic status
Time frame: 1 year after transplantation
Correlation between cccDNA rate and patient's treatment
Time frame: 1 year after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 37879886Testoni 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.
- Derived from this study: PubMed 37122357Villeret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien ZOULIM, MD, PhD principal investigator
Service d'Hépatologie, Hôpital Croix-Rousse, Hospices Civils de Lyon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Hospices Civils de Lyon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy (time frame: 1 year after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.