Chronic Hepatitis B VirusVHB-RocheNCT05099458
T-cell Dysfunction in Chronic HBV Infection
A study testing Additional blood sampling (100 ml) in people with Chronic Hepatitis B Virus, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Chronic hepatitis B (CHB) infection remains an important public health with more than 240 million people chronically infected despite the existence of an effective vaccine. Cirrhosis and hepatocellular carcinoma (HCC) are major complications of CHB infection and are responsible for more than 600,000 deaths each year. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Chronic Hepatitis B Virus
- What is being tested?
- Additional blood sampling (100 ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2019to 25 Apr 2022
- Phase
- Interventional
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For all patients
- Compensated liver disease defined by the following criteria: Conjugated bilirubin level ≤ 1.2 x upper limit of normal (ULN), TP / INR ≤ 1.2 × ULN, platelets ≥ 150 x 109 / L, serum albumin ≥ 35 g / L, and no history of clinical hepatic decompensation (ascites, jaundice, encephalopathy, variceal hemorrhage) (results from a blood test dating up to 8 months before inclusion).
- Adequate haematological function: platelets ≥ 150x109 / L, Hb ≥ 12 g / dL (male) or ≥ 11 g / dL (female), white blood cells ≥4x109 / L and <11x109 / L, except for ethnic neutropenia (these values must be obtained at least 8 months before inclusion)
- Male or female between 20 and 69 years of age, inclusive
- 18.5 ≤BMI ≤ 35 kg / m²
- Patients who dated and signed informed consent
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- For patients chronically infected with NUC treatment for more than 6 months:
- HBV DNA <25 IU / mL
- HBsAg-positive (≥100 IU / mL)
- HBeAg-negative or positive
- ALT <1.5x ULN
- For chronically infected, untreated patients:
- HBsAg positive (≥100 IU / mL)
- negative or positive HBeAg
- HBV DNA> 2000 IU / mL
- ALT <2 x ULN
Who cannot join
- Use of steroids or other immunosuppressive agents that would affect the number and / or function of immune cells in the last 4 weeks
- •,Any disease or other major medical disorder or condition that , that, in the judgment of the investigator, would interfere with results of the study (including, but not limited to: cancer, systemic lupus erythematosus, rheumatoid arthritis or other autoimmune disease, etc. ...)
- Major surgery or traumatic injury (including blood transfusion) in the last 4 weeks
- -• Use of an experimental drug in the last 12 weeks
- Positive test for Hepatitis C, HIV, Hepatitis D, or Hepatitis A (anti-HAV IgM) at the time of inclusion
- Significant acute infection such as influenza or other clinically significant illness in the last 2 weeks
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- History of drug abuse in the last year
- positive pregnancy test for women of childbearing age
- Breast-feeding women
- Patients presenting:
- a medical history or signs of cirrhosis defined by a biopsy result or any other non-invasive validated test showing cirrhosis, OR
- Either during the selection visit: a transient elastography value ≥ 10.5 kPa OR a Fibrotest® / Fibrosure® score ≥ 0.48 and an APRI score ≥1 .
- Note: If a biopsy or a non-invasive test for cirrhosis has never been performed in the patient, then the medical examinations described in b) must be performed during the selection visit.
- History of ascites, digestive hemorrhage and / or encephalopathy
- Any co-morbidity that could lead to liver damage as judged by the investigator (excessive alcohol consumption, hemochromatosis, Wilson's disease, autoimmune hepatitis, inflammatory colitis ...)
- Patients unable or unwilling to comply with the protocol requirements
- Patient unable to give informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg, 67000
eRIC DEMONSANT, eric.demonsant@chru-strasbourg.fr
About this study
Official title: Characterization of Molecular Signature Associated With T-cell Dysfunction Observed During Chronic HBV Infection
Chronic hepatitis B (CHB) infection remains an important public health with more than 240 million people chronically infected despite the existence of an effective vaccine. Cirrhosis and hepatocellular carcinoma (HCC) are major complications of CHB infection and are responsible for more than 600,000 deaths each year. These complications are strongly related to the function of the immune system. Indeed, the persistence of HBV and the progression of liver disease are mainly due to the development of an ineffective immune response to HBV. Therefore, the clinical outcome depends on the complex interaction between HBV replication and adaptive immune responses.
The ultimate goal of antiviral treatments is the elimination of HBsAgHBs and the appearance of anti-HBs antibodies without detectable PCR replication. Current treatments are effective at lowering viral DNA levels, but they are not able to permanently eliminate chronic HBV infection, due to the persistence of cDNA in the nucleus of infected hepatocytes. This therapeutic goal is rarely achieved and new therapeutic approaches are needed. In this sense, Immunotherapy represents a very promising new therapeutic approach that could lead to the cure of chronic HBV infection. Indeed, HBV infection is characterized by a progressive depletion of T lymphocytes which results in a progressive loss of function, associated with a sustained positive regulation of inhibitory control molecules.
Thus, the objective of this study is to define the immune signature and the main control pathways associated with T-cell depletion in patients chronically infected with HBV, by analyzing immune cells isolated from these patients at phenotypic , transcriptional and functional levels
- Conditions
- Chronic Hepatitis B Virus
- Being tested
- Additional blood sampling (100 ml)
- Keywords
- T lymphocytes, Exhaustion, Molecular signature
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood sampling (100 ml)Biological
only an additional blood volume will be collected at the same time of the standard blood collection for these patients
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B | Experimental | Not described Receives: Biological: Additional blood sampling (100 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypic analyze of exhausted T-cells (CD4 and CD8)
a blood sample will be analysed to see the impact of chronic HBV infection on T cell dysfunction.
Measured: Day 0
Transcriptional analyze of exhausted T-cells (CD4 and CD8)
a blood sample will be analysed to see the impact of chronic HBV infection on T cell dysfunction.
Measured: Day 0
Secondary outcomes (1)
Response to functional T-cells stimulation tests
This response will be evaluated by functional T cell stimulation tests in the presence or absence of immunomodulatory molecules targeting immune checkpoint receptors such as PD1, but also Tim-3, LAG3 or others.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start15 Apr 2019
- Primary completion25 Apr 2022 (estimated)
- Study completion25 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B VirusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François HABERSETZER, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099458
- Sponsor's protocol ID
- 6847
- Acronym
- VHB-Roche
- Status last verified
- Oct 2021
- First submitted
- 23 Nov 2018
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Molecular Signature Associated With T-cell Dysfunction Observed During Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT05099458
- Acronym / sponsor ID
- VHB-Roche / 6847
- Conditions
- Chronic Hepatitis B Virus
- Keywords
- T lymphocytes, Exhaustion, Molecular signature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 25 Apr 2022 (estimated)
- Study completion
- 25 Apr 2022 (estimated)
- First posted
- 29 Oct 2021 (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.
Chronic hepatitis B (CHB) infection remains an important public health with more than 240 million people chronically infected despite the existence of an effective vaccine. Cirrhosis and hepatocellular carcinoma (HCC) are major complications of CHB infection and are responsible for more than 600,000 deaths each year. These complications are strongly related to the function of the immune system. Indeed, the persistence of HBV and the progression of liver disease are mainly due to the development of an ineffective immune response to HBV. Therefore, the clinical outcome depends on the complex interaction between HBV replication and adaptive immune responses.
The ultimate goal of antiviral treatments is the elimination of HBsAgHBs and the appearance of anti-HBs antibodies without detectable PCR replication. Current treatments are effective at lowering viral DNA levels, but they are not able to permanently eliminate chronic HBV infection, due to the persistence of cDNA in the nucleus of infected hepatocytes. This therapeutic goal is rarely achieved and new therapeutic approaches are needed. In this sense, Immunotherapy represents a very promising new therapeutic approach that could lead to the cure of chronic HBV infection. Indeed, HBV infection is characterized by a progressive depletion of T lymphocytes which results in a progressive loss of function, associated with a sustained positive regulation of inhibitory control molecules.
Thus, the objective of this study is to define the immune signature and the main control pathways associated with T-cell depletion in patients chronically infected with HBV, by analyzing immune cells isolated from these patients at phenotypic , transcriptional and functional levels
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B | Experimental | Biological: Additional blood sampling (100 ml) |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For all patients
- For patients chronically infected with NUC treatment for more than 6 months:
- For chronically infected, untreated patients:
Key exclusion criteria (17 listed)
- Use of steroids or other immunosuppressive agents that would affect the number and / or function of immune cells in the last 4 weeks
- •,Any disease or other major medical disorder or condition that , that, in the judgment of the investigator, would interfere with results of the study (including, but not limited to: cancer, systemic lupus erythematosus, rheumatoid arthritis or other autoimmune disease, etc. ...)
- Major surgery or traumatic injury (including blood transfusion) in the last 4 weeks
- -• Use of an experimental drug in the last 12 weeks
- Positive test for Hepatitis C, HIV, Hepatitis D, or Hepatitis A (anti-HAV IgM) at the time of inclusion
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 |
|---|---|---|
| Additional blood sampling (100 ml)only an additional blood volume will be collected at the same time of the standard blood collection for these patients | Biological | Hepatitis B |
Primary outcome
Phenotypic analyze of exhausted T-cells (CD4 and CD8)
Time frame: Day 0
a blood sample will be analysed to see the impact of chronic HBV infection on T cell dysfunction.
Transcriptional analyze of exhausted T-cells (CD4 and CD8)
Time frame: Day 0
a blood sample will be analysed to see the impact of chronic HBV infection on T cell dysfunction.
1 secondary outcome
Response to functional T-cells stimulation tests
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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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.
François HABERSETZER, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional blood sampling (100 ml) in people with Chronic Hepatitis B Virus, run by University Hospital, Strasbourg, France 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 16 inclusion and 17 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 29 Oct 2021. 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 François HABERSETZER, MD (3 69 55 10 09 ext. 0033, francois.habersetzer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypic analyze of exhausted T-cells (CD4 and CD8) (time frame: Day 0). The study lists 2 primary outcomes in all. 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 29 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.