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Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients

Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06029634
Enrollment
45
Registered
2023-09-08
Start date
2020-07-01
Completion date
2023-08-20
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HBV Infection, Drug Withdrawal

Keywords

transcription factor bet, chronic hepatitis B, nucleotide analogs, function cure, B cell

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTT-bet B cell

The frequency, function, and phenotype of T-bet B cells was tested

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

18 to 70 years old, no gender restriction, serum HBsAg positive than 6 months, can understand and sign informed consent, good compliance.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
phenotype of B cellsPBMC were collected 0、4、12、24 week after withdraw the NAsCD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.
B cell ELISPOT assayCells 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 differentiationSorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026