HBVHepatoDCNCT03753308
Mechanism of DCs Dysfunction in Chronic HBV Infection
An observational study of HBV and NASH - Nonalcoholic Steatohepatitis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This research is to better understand the functional impairments of Dendritic cells (DCs) in chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral components and the molecular mechanisms of DCs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HBV, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Blood Sampling and Liver biopsy
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2018to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 88 HBV patients (44 blood sampling, 44 liver biopsy), 44 NASH patients (liver biopsy)
Who may be able to join
- Group 1a: HBV positive patients / no scheduled biopsy
- Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
- Patients who signed a non-opposition
- Patient affiliated to social security insurance
- HBsAg positive for more than 6 months
- known status of HBeAg (positive or negative)
Show all 24Show fewer
- Treated or not with an antiviral
- Group 1b: HBV positive patients / with scheduled biopsy
- Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
- Patients who signed a non-opposition
- Patient affiliated to social security insurance
- HBsAg positive for more than 6 months
- known status of HBeAg (positive or negative)
- Treated or not with an antiviral
- Patient with a liver biopsy indication as part of the treatment within 3 months.
- Group 2: NASH patients / with scheduled biopsy
- Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
- Patients who signed a non-opposition
- Patient affiliated to social security insurance
- The existence of at least one element of metabolic syndrome
- Steatosis detected by non-invasive tests (echo, CAP, MRI)
- Group 3: Blood samples from healthy donors
- No subject will be included in this group, the samples have been already collected at EFS from healthy donors who had previously given their informed consents for using their blood samples in the research.
- The blood samples have been collected in sufficient quantity to carry out the analyzes (20mL from each donor).
Who cannot join
- For groups 1a, 1b and 2 (HBV or NASH patients):
- Positive serology for HCV, HDV, HTLV, HIV
- Active autoimmune diseases
- Immunosuppressive therapies
- Cancer <2 years
- Alcohol: male> 30g / day, female> 20g / day
Show all 13Show fewer
- Group 1a and 1b:
- NASH patients
- Group 2:
- Positive HBsAg Group 3: Blood samples from healthy donors
- Positive serology for HCV, HTLV, HIV, HBV (in the sense of a positive HBsAg test).
- Risk of any infectious disease at the time of sample collection (including fever> 38 ° C over the past 15 days or recent contact with a person with a contagious disease).
- Autoimmune disease or immunosuppressive therapy at the time of sample collection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Vincent LEROY, 04 76 76 93 68, vleroy@chu-grenoble.fr
Laure BORDY, 04 76 76 61 50, lbordy@chu-grenoble.fr
About this study
This research is to better understand the functional impairments of Dendritic cells (DCs) in chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms by which the immune response is altered by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity
Read the detailed description
Currently, chronic hepatitis B virus (HBV) infection therapies are limited to pegylated interferon alpha (Peg-IFNα) and nucleos(t)ide analogues (NUCs), alone or in combination. Even though they can reduce viremia level (circulating viral load), the loss of HBs antigen (HBsAg), which indicates functional clearance of the virus, is achieved in less than 10% of cases.
The absence of curative treatment to eliminate the infection justifies the need to define new targets and to develop new therapeutic strategies, with an immuno-therapeutic component.
Chronic HBV infection is associated with persistent and virally-induced immune deficiency. The immunological control of the infection seems essential to the functional clearance of the virus. The restoration of appropriate immune responses against the virus could prove to be a promising therapeutic strategy. However, the mechanisms in which HBV modulates immune function is still poorly understood.
Dendritic cells (DCs) have an essential role in immunity. They play a central role in the induction and regulation of immune responses. Also, they play a particularly crucial role in the induction and orientation of antiviral immunity due to their unique properties at the interface between innate and acquired immune responses. In several chronic viral infections, DCs appear defective. The immune responses induced in the early stages of infection seem to be a crucial guide on the progression of the infection into the resolution or the chronicity.
Objective of the investigators is to better understand the virus escape mechanism from immune control, particularly, to determine the mechanisms in which the virus modulates the functions of DCs, crucial for the subsequent orientation of antiviral immune responses, to define the molecular mechanisms of this inhibition and their consequences on the antiviral effectors functions, in order to propose new immunotherapeutic approaches that compromise the chronicity of the infection and treat the infection permanently and definitively.
Lastly, the investigators have shown that there are functional impairments in plasmacytoid DCs (pDCs) in patients with chronic hepatitis B, associated with a lack of cytotoxic activity of NK cells. The Subverting of pDCs in HBV patients could be related to IP-10 and HBsAg and HBeAg antigens or other viral components (infectious particles or circulating HBcAg). In addition, HBV was able to inhibit the production of IFNα by pDCs from healthy individuals in response to TLR9 agonists, by the presence of inhibitory CpG sequences in its genome. This mechanism would allow the virus to actively escape the innate immune response mounted by pDCs. Recently, investigators have found an alteration of lectin C-type receptor (CLR) expression on pDCs of HBV patients compared to healthy donors as well as a phenotypic and functional modulation in the 3 major subtypes of DCs (mDCs BDCA1 +, pDCs BDCA2 + and mDCs BDCA3 +) in the context of chronic HBV infection. These major subversions of DCs, crucial cells for subsequent orientation of antiviral immune responses, support the hypothesis that HBV might deflect immunity by impacting these cells.
In this clinical trial, investigators would like to pursue their research to better understand the functional impairments of DCs in chronic HBV infection, by defining if the virus is able to bind to the CLRs of DCs to modulate their functions, and by defining the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms of the immune response orientation by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity
- Conditions
- HBV, NASH - Nonalcoholic Steatohepatitis
- Being tested
- Blood Sampling, Liver biopsy
- Keywords
- Dendritic cells, C-type lectins (CLR), mDCs BDCA1+ and BDCA3+ circulating and hepatic
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingBiological
5 x Lithium Heparin Tubes WITHOUT DARK GREEN GEL, 5 ml- v. 4 ml Blood volumes collected as part of the usual care and this research comply with the recommendations of Jarde's law for an observational study (less than 80 ml in one day and less than 160 ml over 30 consecutive days for a subject over 40kg).
Liver biopsyBiological
The liver biopsy is part of the usual care and it follows the usual procedure of CHUGA:
The patient is placed in a supine position and received a transitory sedation, MEOPA gas (Kalinox®). Also, an ultrasound scan is performed. Local disinfection followed by local anesthesia with Xylocaine® are performed. The biopsy is performed with the Hepafix 17 gauge needle. 1 passage is carried out to obtain a biopsy fragment of at least 20 mm for the diagnosis (if the passage is unsuccessful, a second passage can be performed strictly as part of the usual care and not as part of research). If the biopsy is> 20 mm, a fragment of the excess biopsy specimen (10% or 2 mm) will be cut and used for research in groups 1b and 2. This division is performed by the clinician directly on the fresh specimen
| Study group | Role | What they receive |
|---|---|---|
| 1a, HBV patients / no scheduled biopsy | Intervention : Blood Sampling
Eligibility criteria :
* Male or female, Age of 18 or older, Weight over 40kg
* Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
* Patients who signed a non-opposition
* Patient affiliated to social security insurance
* HBsAg positive for more than 6 months
* known status of HBeAg (positive or negative)
* Treated or not with an antiviral Receives: Biological: Blood Sampling | |
| 1b, HBV patients / with scheduled biopsy | Intervention : Liver biopsy
Eligibility criteria :
* Male or female, Age of 18 or older, Weight over 40kg
* Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
* Patients who signed a non-opposition
* Patient affiliated to social security insurance
* HBsAg positive for more than 6 months
* known status of HBeAg (positive or negative)
* Treated or not with an antiviral
* Patient with a liver biopsy indication as part of the treatment within 3 months. Receives: Biological: Liver biopsy | |
| 2, NASH patients / with scheduled biopsy | Intervention : Liver biopsy
Eligibility criteria :
* Male or female, Age of 18 or older, Weight over 40kg
* Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
* Patients who signed a non-opposition
* Patient affiliated to social security insurance
* The existence of at least one element of metabolic syndrome
* Steatosis detected by non-invasive tests (echo, CAP, MRI) Receives: Biological: Liver biopsy | |
| 3, Blood samples from healthy donors | * No subject will be included in this group, the samples have been already collected at EFS from healthy donors who had previously given their informed consents for using their blood samples in the research.
* The blood samples have been collected in sufficient quantity to carry out the analyzes (20mL from each donor). Receives: Biological: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the subversion mechanism of dendritic cells (DCs) by hepatitis B virus (HBV)
Differential expression of the tested molecules (DCIR, dectin 1, DEC205, DC-SIGN, Clec12a, CD206, CD207, Clec9a, CD32) on circulating and hepatic mDCs (BDCA1+ et BDCA3+) of HBV patients compared to controls (healthy donors for circulating DCs, or NASH patients for hepatic DCs)
Measured: 4 years
Secondary outcomes (1)
Demonstrate the correlations between immunological and clinical parameters
Identify of clinical evolution prognostic factors and determine significant correlations between measured immunological parameters and HBV infection parameters (plasma levels of HBV DNA, HBsAg, HBeAg, ALT)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start5 Dec 2018
- Primary completion5 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Etablissement Français du Sang
- Responsible party
- Sponsor
- Investigators
- Vincent LEROY, Pr, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753308
- Sponsor's protocol ID
- 38RC18.198
- Acronym
- HepatoDC
- Status last verified
- Aug 2020
- First submitted
- 23 Nov 2018
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of DCs Dysfunction in Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT03753308
- Acronym / sponsor ID
- HepatoDC / 38RC18.198
- Conditions
- HBV, NASH - Nonalcoholic Steatohepatitis
- Keywords
- Dendritic cells, C-type lectins (CLR), mDCs BDCA1+ and BDCA3+ circulating and hepatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Etablissement Français du Sang
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 5 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Nov 2018 (actual)
- 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.
This research is to better understand the functional impairments of Dendritic cells (DCs) in chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms by which the immune response is altered by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity
Detailed description
Currently, chronic hepatitis B virus (HBV) infection therapies are limited to pegylated interferon alpha (Peg-IFNα) and nucleos(t)ide analogues (NUCs), alone or in combination. Even though they can reduce viremia level (circulating viral load), the loss of HBs antigen (HBsAg), which indicates functional clearance of the virus, is achieved in less than 10% of cases.
The absence of curative treatment to eliminate the infection justifies the need to define new targets and to develop new therapeutic strategies, with an immuno-therapeutic component.
Chronic HBV infection is associated with persistent and virally-induced immune deficiency. The immunological control of the infection seems essential to the functional clearance of the virus. The restoration of appropriate immune responses against the virus could prove to be a promising therapeutic strategy. However, the mechanisms in which HBV modulates immune function is still poorly understood.
Dendritic cells (DCs) have an essential role in immunity. They play a central role in the induction and regulation of immune responses. Also, they play a particularly crucial role in the induction and orientation of antiviral immunity due to their unique properties at the interface between innate and acquired immune responses. In several chronic viral infections, DCs appear defective. The immune responses induced in the early stages of infection seem to be a crucial guide on the progression of the infection into the resolution or the chronicity.
Objective of the investigators is to better understand the virus escape mechanism from immune control, particularly, to determine the mechanisms in which the virus modulates the functions of DCs, crucial for the subsequent orientation of antiviral immune responses, to define the molecular mechanisms of this inhibition and their consequences on the antiviral effectors functions, in order to propose new immunotherapeutic approaches that compromise the chronicity of the infection and treat the infection permanently and definitively.
Lastly, the investigators have shown that there are functional impairments in plasmacytoid DCs (pDCs) in patients with chronic hepatitis B, associated with a lack of cytotoxic activity of NK cells. The Subverting of pDCs in HBV patients could be related to IP-10 and HBsAg and HBeAg antigens or other viral components (infectious particles or circulating HBcAg). In addition, HBV was able to inhibit the production of IFNα by pDCs from healthy individuals in response to TLR9 agonists, by the presence of inhibitory CpG sequences in its genome. This mechanism would allow the virus to actively escape the innate immune response mounted by pDCs. Recently, investigators have found an alteration of lectin C-type receptor (CLR) expression on pDCs of HBV patients compared to healthy donors as well as a phenotypic and functional modulation in the 3 major subtypes of DCs (mDCs BDCA1 +, pDCs BDCA2 + and mDCs BDCA3 +) in the context of chronic HBV infection. These major subversions of DCs, crucial cells for subsequent orientation of antiviral immune responses, support the hypothesis that HBV might deflect immunity by impacting these cells.
In this clinical trial, investigators would like to pursue their research to better understand the functional impairments of DCs in chronic HBV infection, by defining if the virus is able to bind to the CLRs of DCs to modulate their functions, and by defining the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms of the immune response orientation by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1a, HBV patients / no scheduled biopsy | – | Biological: Blood SamplingIntervention : Blood Sampling Eligibility criteria : * Male or female, Age of 18 or older, Weight over 40kg * Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA * Patients who signed a non-opposition * Patient affiliated to social security insurance * HBsAg positive for more than 6 months * known status of HBeAg (positive or negative) * Treated or not with an antiviral |
| 1b, HBV patients / with scheduled biopsy | – | Biological: Liver biopsyIntervention : Liver biopsy Eligibility criteria : * Male or female, Age of 18 or older, Weight over 40kg * Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA * Patients who signed a non-opposition * Patient affiliated to social security insurance * HBsAg positive for more than 6 months * known status of HBeAg (positive or negative) * Treated or not with an antiviral * Patient with a liver biopsy indication as part of the treatment within 3 months. |
| 2, NASH patients / with scheduled biopsy | – | Biological: Liver biopsyIntervention : Liver biopsy Eligibility criteria : * Male or female, Age of 18 or older, Weight over 40kg * Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA * Patients who signed a non-opposition * Patient affiliated to social security insurance * The existence of at least one element of metabolic syndrome * Steatosis detected by non-invasive tests (echo, CAP, MRI) |
| 3, Blood samples from healthy donors | – | Biological: Blood Sampling* No subject will be included in this group, the samples have been already collected at EFS from healthy donors who had previously given their informed consents for using their blood samples in the research. * The blood samples have been collected in sufficient quantity to carry out the analyzes (20mL from each donor). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 88 HBV patients (44 blood sampling, 44 liver biopsy), 44 NASH patients (liver biopsy)
Key inclusion criteria (24 listed)
- Group 1a: HBV positive patients / no scheduled biopsy
- Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
- Patients who signed a non-opposition
- Patient affiliated to social security insurance
- HBsAg positive for more than 6 months
Key exclusion criteria (13 listed)
- Positive serology for HCV, HDV, HTLV, HIV
- Active autoimmune diseases
- Immunosuppressive therapies
- Cancer <2 years
- Alcohol: male> 30g / day, female> 20g / day
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 |
|---|---|---|
| Blood Sampling5 x Lithium Heparin Tubes WITHOUT DARK GREEN GEL, 5 ml- v. 4 ml Blood volumes collected as part of the usual care and this research comply with the recommendations of Jarde's law for an observational study (less than 80 ml in one day and less than 160 ml over 30 consecutive days for a subject over 40kg). | Biological | 1a, HBV patients / no scheduled biopsy, 3, Blood samples from healthy donors |
| Liver biopsyThe liver biopsy is part of the usual care and it follows the usual procedure of CHUGA: The patient is placed in a supine position and received a transitory sedation, MEOPA gas (Kalinox®). Also, an ultrasound scan is performed. Local disinfection followed by local anesthesia with Xylocaine® are performed. The biopsy is performed with the Hepafix 17 gauge needle. 1 passage is carried out to obtain a biopsy fragment of at least 20 mm for the diagnosis (if the passage is unsuccessful, a second passage can be performed strictly as part of the usual care and not as part of research). If the biopsy is> 20 mm, a fragment of the excess biopsy specimen (10% or 2 mm) will be cut and used for research in groups 1b and 2. This division is performed by the clinician directly on the fresh specimen | Biological | 1b, HBV patients / with scheduled biopsy, 2, NASH patients / with scheduled biopsy |
Primary outcome
Define the subversion mechanism of dendritic cells (DCs) by hepatitis B virus (HBV)
Time frame: 4 years
Differential expression of the tested molecules (DCIR, dectin 1, DEC205, DC-SIGN, Clec12a, CD206, CD207, Clec9a, CD32) on circulating and hepatic mDCs (BDCA1+ et BDCA3+) of HBV patients compared to controls (healthy donors for circulating DCs, or NASH patients for hepatic DCs)
1 secondary outcome
Demonstrate the correlations between immunological and clinical parameters
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Vincent LEROY, Pr principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV and NASH - Nonalcoholic Steatohepatitis, run by University Hospital, Grenoble at 1 site 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 24 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent LEROY, Pr (04 76 76 93 68, vleroy@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the subversion mechanism of dendritic cells (DCs) by hepatitis B virus (HBV) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2020.