xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06029634</url>
    </required_header>
    <id_info>
      <org_study_id>T-bet B</org_study_id>
      <nct_id>NCT06029634</nct_id>
    </id_info>
    <brief_title>Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients</brief_title>
    <official_title>Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changhai Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication&#xD;
        effectively while having a low sustained virus control rate after drug withdrawal is unclear.&#xD;
        B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the&#xD;
        virus under control. T-bet+ B, which can be regulated by IL-21, is a newly discovered major&#xD;
        effector B cell in protection of pathogens and it is a main subtype of HBsAg-specific B&#xD;
        cells. Thus, we suspect that T-bet+ B may play a role in ongoing controlling of the virus&#xD;
        after withdraw of NAs in CHB patient. Based on our previous studies on CHB immunity, we use&#xD;
        the RNAseq analyse, flow cytometry, and Elispot assay to analyze the frequency, function, and&#xD;
        phenotype of B cells in CHB patients with different profiles after withdraw of NAs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2020</start_date>
    <completion_date type="Actual">August 20, 2023</completion_date>
    <primary_completion_date type="Actual">August 10, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>phenotype of B cells</measure>
      <time_frame>PBMC were collected 0、4、12、24 week after withdraw the NAs</time_frame>
      <description>CD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>B cell ELISPOT assay</measure>
      <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</time_frame>
      <description>Sorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">45</enrollment>
    <condition>Chronic HBV Infection</condition>
    <condition>Drug Withdrawal</condition>
    <arm_group>
      <arm_group_label>virologic breakthrough</arm_group_label>
      <description>CHB patients withdraw NAs with virologic breakthrough</description>
    </arm_group>
    <arm_group>
      <arm_group_label>virologic response</arm_group_label>
      <description>CHB patients withdraw NAs with virologic response</description>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy group</arm_group_label>
      <description>The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>T-bet B cell</intervention_name>
      <description>The frequency, function, and phenotype of T-bet B cells was tested</description>
      <arm_group_label>healthy group</arm_group_label>
      <arm_group_label>virologic breakthrough</arm_group_label>
      <arm_group_label>virologic response</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        pbmc&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          CHB patients on NAs therapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          18 to 70 years old, no gender restriction, serum HBsAg positive than 6 months, can&#xD;
          understand and sign informed consent, good compliance.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D&#xD;
          -virus,hepatitis E and hepatitis A etc; coinfected with HIV, markers such as ceruloplasmin,&#xD;
          anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and&#xD;
          metabolic liver diseases were positive, with hepatocellular carcinoma(HCC) with&#xD;
          uncontrollable extrehepatic disease, received glucocorticoid or other immune inhibitor&#xD;
          therapy, pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xuesong Liang, DR</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chaihai hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Changhai hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200433</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Changhai Hospital</investigator_affiliation>
      <investigator_full_name>XueSong Liang</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <keyword>transcription factor bet</keyword>
    <keyword>chronic hepatitis B</keyword>
    <keyword>nucleotide analogs</keyword>
    <keyword>function cure</keyword>
    <keyword>B cell</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance Withdrawal Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06029634
  org study id: T-bet B
  nct id: NCT06029634
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: phenotype of B cells
  time frame: PBMC were collected 0、4、12、24 week after withdraw the NAs
  description: CD19+cells were sorted from different samples, the frequency, function, and phenotype of B cells were analyzed.
  measure: 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
  description: Sorted B cell subsets were stimulated for 5 days following which B cell ELISPOT was conducted.
  arm group label: virologic breakthrough
  description: CHB patients withdraw NAs with virologic breakthrough
  arm group label: virologic response
  description: CHB patients withdraw NAs with virologic response
  arm group label: healthy group
  description: The healthy (non-HBV infected) group completed a standard HBsAg vaccination scheduled before entering the study
  intervention type: Diagnostic Test
  intervention name: T-bet B cell
  description: The frequency, function, and phenotype of T-bet B cells was tested
  arm group label: healthy group
  arm group label: virologic breakthrough
  arm group label: virologic response
  pbmc
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xuesong Liang, DR
  role: Principal Investigator
  affiliation: Chaihai hospital
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Changhai Hospital
  investigator full name: XueSong Liang
  investigator title: Dr
  mesh term: Substance Withdrawal Syndrome
  sharing ipd: No