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

NCT ID: NCT06029634

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic HBV Infection Drug Withdrawal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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virologic breakthrough

CHB patients withdraw NAs with virologic breakthrough

T-bet B cell

Intervention Type DIAGNOSTIC_TEST

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

virologic response

CHB patients withdraw NAs with virologic response

T-bet B cell

Intervention Type DIAGNOSTIC_TEST

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

healthy group

The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study

T-bet B cell

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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T-bet B cell

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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XueSong Liang

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuesong Liang, DR

Role: PRINCIPAL_INVESTIGATOR

Chaihai hospital

Locations

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Changhai hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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T-bet B

Identifier Type: -

Identifier Source: org_study_id

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