---
title: Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients
nct_id: NCT06029634
overall_status: COMPLETED
sponsor: Changhai Hospital
study_type: OBSERVATIONAL
primary_condition: Chronic HBV Infection
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06029634.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06029634"
ct_last_update_post_date: 2023-09-08
last_seen_at: "2026-05-12T06:35:25.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients

**NCT ID:** [NCT06029634](https://clinicaltrials.gov/study/NCT06029634)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 45
- **Lead Sponsor:** Changhai Hospital
- **Conditions:** Chronic HBV Infection, Drug Withdrawal
- **Start Date:** 2020-07-01
- **Completion Date:** 2023-08-20
- **CT.gov Last Update:** 2023-09-08

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **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
```

## Arms

- **virologic breakthrough** — CHB patients withdraw NAs with virologic breakthrough
- **virologic response** — CHB patients withdraw NAs with virologic response
- **healthy group** — The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study

## Interventions

- **T-bet B cell** (DIAGNOSTIC_TEST) — The frequency, function, and phenotype of T-bet B cells was tested

## Primary Outcomes

- **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.

## Locations (1)

- Changhai hospital, Shanghai, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.changhai hospital|shanghai||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06029634.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06029634*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*