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

Chronic HBV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06029634
• Other study ID #: T-bet B
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: August 20, 2023

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 20, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic HBV Infection
• Drug Withdrawal
• Substance Withdrawal Syndrome

Intervention

Diagnostic Test:
• T-bet B cell
The frequency, function, and phenotype of T-bet B cells was tested

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phenotype of B cells	CD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.	PBMC were collected 0?4?12?24 week after withdraw the NAs
Primary	B cell ELISPOT assay	Sorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.	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