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

N

Naval Military Medical University

Status

Completed

Conditions

Chronic HBV Infection
Drug Withdrawal

Treatments

Diagnostic Test: T-bet B cell

Study type

Observational

Funder types

Other

Identifiers

NCT06029634
T-bet B

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

virologic breakthrough
Description:
CHB patients withdraw NAs with virologic breakthrough
Treatment:
Diagnostic Test: T-bet B cell
virologic response
Description:
CHB patients withdraw NAs with virologic response
Treatment:
Diagnostic Test: T-bet B cell
healthy group
Description:
The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study
Treatment:
Diagnostic Test: T-bet B cell

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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