<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/NCT04483518</url>
  </required_header>
  <id_info>
    <org_study_id>19K056-001</org_study_id>
    <nct_id>NCT04483518</nct_id>
  </id_info>
  <brief_title>Epidemiological Survey of Hepatitis D Virus Infection in China</brief_title>
  <official_title>Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fourth Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This cross-sectional study will screen out hepatitis D virus-infected patients in&#xD;
      HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among&#xD;
      HBsAg positive people. The provinces of China are divided into 5 geographical areas (North,&#xD;
      South, East, West and Central) to recruit patients according to the population density of&#xD;
      each area. After statistical calculation, the total number of population needed is 3808.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Entry criteria：1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV&#xD;
      infection (HBsAg positive) 4.Ability to sign informed consent.&#xD;
&#xD;
      Exclusion criteria：Patients who disagree to participate in the trial.&#xD;
&#xD;
      After the informed consent was signed, the quantitative data of the previous surface antigen&#xD;
      or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on&#xD;
      the same day or the remaining serum from the surface antigen or hepatitis B quantitative test&#xD;
      was collected for the detection of hepatitis D antibody and/or the quantitative detection of&#xD;
      hepatitis D RNA.&#xD;
&#xD;
      After statistical analysis, calculate the hepatitis D infection status in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2019</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">July 7, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of hepatitis D virus</measure>
    <time_frame>2019-2020</time_frame>
    <description>Proportion of hepatitis D infection in people with hepatitis B infection</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5000</enrollment>
  <condition>Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People</condition>
  <arm_group>
    <arm_group_label>HBV patients</arm_group_label>
    <description>HBV patients with HBsAg positive and/or HBV DNA positive</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples are used to detect HDV antibodies or HDV RNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hepatitis B surface antigen or HBV DNA positive&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hepatitis B surface antigen or HBV DNA positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Can't sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junqi Niu, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the first hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
    <investigator_full_name>Junqi Niu</investigator_full_name>
    <investigator_title>Director of the department of Hepatology</investigator_title>
  </responsible_party>
  <keyword>HBsAg positive</keyword>
  <keyword>HBV DNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis D</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Infection rate data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04483518
org study id: 19K056-001
nct id: NCT04483518
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This cross-sectional study will screen out hepatitis D virus-infected patients in
      HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among
      HBsAg positive people. The provinces of China are divided into 5 geographical areas (North,
      South, East, West and Central) to recruit patients according to the population density of
      each area. After statistical calculation, the total number of population needed is 3808.
Entry criteria：1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV
      infection (HBsAg positive) 4.Ability to sign informed consent.

      Exclusion criteria：Patients who disagree to participate in the trial.

      After the informed consent was signed, the quantitative data of the previous surface antigen
      or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on
      the same day or the remaining serum from the surface antigen or hepatitis B quantitative test
      was collected for the detection of hepatitis D antibody and/or the quantitative detection of
      hepatitis D RNA.

      After statistical analysis, calculate the hepatitis D infection status in China.
observational model: Cohort
time perspective: Cross-Sectional
measure: The prevalence of hepatitis D virus
time frame: 2019-2020
description: Proportion of hepatitis D infection in people with hepatitis B infection
arm group label: HBV patients
description: HBV patients with HBsAg positive and/or HBV DNA positive
Serum samples are used to detect HDV antibodies or HDV RNA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Junqi Niu, Dr.
role: Study Director
affiliation: The First Hospital of Jilin University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Hospital of Jilin University
investigator full name: Junqi Niu
investigator title: Director of the department of Hepatology
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Virus Diseases
mesh term: Hepatitis D
mesh term: Hepatitis
sharing ipd: No
ipd description: Infection rate data