Chronic HBV InfectionNCT06029634
Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
An observational study of Chronic HBV Infection and Drug Withdrawal, run by Changhai Hospital at 1 site in China.
Trial summary
The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication effectively while having a low sustained virus control rate after drug withdrawal is unclear. B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the virus under control. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic HBV Infection, Drug Withdrawal
- What is being tested?
- T-bet B cell
- Type of treatment
- Vaccines
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 20 Aug 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CHB patients on NAs therapy
Who may be able to join
- 18 to 70 years old, no gender restriction, serum HBsAg positive than 6 months, can understand and sign informed consent, good compliance.
Who cannot join
- coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc; coinfected with HIV, markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive, with hepatocellular carcinoma(HCC) with uncontrollable extrehepatic disease, received glucocorticoid or other immune inhibitor therapy, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication effectively while having a low sustained virus control rate after drug withdrawal is unclear. B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the virus under control. T-bet+ B, which can be regulated by IL-21, is a newly discovered major effector B cell in protection of pathogens and it is a main subtype of HBsAg-specific B cells. Thus, we suspect that T-bet+ B may play a role in ongoing controlling of the virus after withdraw of NAs in CHB patient. Based on our previous studies on CHB immunity, we use the RNAseq analyse, flow cytometry, and Elispot assay to analyze the frequency, function, and phenotype of B cells in CHB patients with different profiles after withdraw of NAs.
- Conditions
- Chronic HBV Infection, Drug Withdrawal
- Being tested
- T-bet B cell
- Keywords
- transcription factor bet, chronic hepatitis B, nucleotide analogs, function cure, B cell
- Medical subject headings
- Substance Withdrawal Syndrome, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-bet B cellDiagnostic test
The frequency, function, and phenotype of T-bet B cells was tested
| Study group | Role | What they receive |
|---|---|---|
| virologic breakthrough | CHB patients withdraw NAs with virologic breakthrough Receives: Diagnostic Test: T-bet B cell | |
| virologic response | CHB patients withdraw NAs with virologic response Receives: Diagnostic Test: T-bet B cell | |
| healthy group | The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study Receives: Diagnostic Test: T-bet B cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
phenotype of B cells
CD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.
Measured: PBMC were collected 0、4、12、24 week after withdraw the NAs
B cell ELISPOT assay
Sorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.
Measured: Cells were stimulated with R-848 (1 μg/ml) and IL-2 (10 ng/ml) for 5 days at 37 °C to aid memory B cell differentiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Jul 2020
- Primary completion10 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XueSong Liang, Changhai Hospital
- Investigators
- Xuesong Liang, DR, Principal investigator, Chaihai hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029634
- Sponsor's protocol ID
- T-bet B
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 8 Sep 2023
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
- ClinicalTrials.gov ID
- NCT06029634
- Acronym / sponsor ID
- T-bet B
- Conditions
- Chronic HBV Infection, Drug Withdrawal
- Keywords
- transcription factor bet, chronic hepatitis B, nucleotide analogs, function cure, B cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 8 Sep 2023 (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.
The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication effectively while having a low sustained virus control rate after drug withdrawal is unclear. B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the virus under control. T-bet+ B, which can be regulated by IL-21, is a newly discovered major effector B cell in protection of pathogens and it is a main subtype of HBsAg-specific B cells. Thus, we suspect that T-bet+ B may play a role in ongoing controlling of the virus after withdraw of NAs in CHB patient. Based on our previous studies on CHB immunity, we use the RNAseq analyse, flow cytometry, and Elispot assay to analyze the frequency, function, and phenotype of B cells in CHB patients with different profiles after withdraw of NAs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| virologic breakthrough | – | Diagnostic Test: T-bet B cellCHB patients withdraw NAs with virologic breakthrough |
| virologic response | – | Diagnostic Test: T-bet B cellCHB patients withdraw NAs with virologic response |
| healthy group | – | Diagnostic Test: T-bet B cellThe healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CHB patients on NAs therapy
Key inclusion criteria (1 listed)
- 18 to 70 years old, no gender restriction, serum HBsAg positive than 6 months, can understand and sign informed consent, good compliance.
Key exclusion criteria (1 listed)
- coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc; coinfected with HIV, markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive, with hepatocellular carcinoma(HCC) with uncontrollable extrehepatic disease, received glucocorticoid or other immune inhibitor therapy, pregnancy
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 |
|---|---|---|
| T-bet B cellThe frequency, function, and phenotype of T-bet B cells was tested | Diagnostic test | healthy group, virologic breakthrough, virologic response |
Primary outcome
phenotype of B cells
Time frame: PBMC were collected 0、4、12、24 week after withdraw the NAs
CD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.
B cell ELISPOT assay
Time frame: Cells were stimulated with R-848 (1 μg/ml) and IL-2 (10 ng/ml) for 5 days at 37 °C to aid memory B cell differentiation
Sorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.
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 8 Sep 2023.
- 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.
Xuesong Liang, DR principal investigator
Chaihai hospital
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 Chronic HBV Infection and Drug Withdrawal, run by Changhai Hospital at 1 site in China.
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 1 inclusion and 1 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 8 Sep 2023. 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 China. 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?
phenotype of B cells (time frame: PBMC were collected 0、4、12、24 week after withdraw the NAs). 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 8 Sep 2023.