<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/NCT02253485</url>
  </required_header>
  <id_info>
    <org_study_id>D121100003912001</org_study_id>
    <nct_id>NCT02253485</nct_id>
  </id_info>
  <brief_title>Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load</brief_title>
  <official_title>Case-control Study of Antiviral Therapy During Entire and the Third Trimester of Pregnancy in Preventing MTCT of HBV in Mothers With High Serum HBV DNA Load</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Ditan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Ditan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV)&#xD;
      infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born&#xD;
      to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is&#xD;
      evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg&#xD;
      positive mothers with high serum HBV DNA loads.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg&#xD;
      positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis(&#xD;
      injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a&#xD;
      HBsAg positive mother with high HBV DNA load before delivery, and based on standard&#xD;
      immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ)&#xD;
      infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral&#xD;
      therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg&#xD;
      positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive&#xD;
      standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA&#xD;
      negative receive standard immunoprophylaxis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mother-to-child transmission of HBV</measure>
    <time_frame>7 months</time_frame>
    <description>HBV infenction in infants at 7 months after birth</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Immune Globulin, Prophylaxis, Telbuvidine, Vaccine</condition>
  <arm_group>
    <arm_group_label>telbivudine treated entire pregnancy</arm_group_label>
    <description>mothers in this group were treated with antiviral therapy during entire pregnancy for hepatitis, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>telbivudine treated in late pregnancy</arm_group_label>
    <description>mothers with high serum HBV DNA load were treated with antiviral therapy in late pregnancy, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HBV DNA positive control</arm_group_label>
    <description>infants in this group born to mother with high serum HBV DNA load and receive standard immunoprophylaxis or additional HBIG injection at 1 month after birth for preventing MTCT of HBV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HBV DNA negative control</arm_group_label>
    <description>infants in this group born to a HBsAg positive and serum HBV DNA negative mothers and receive standard immunoprophylaxis for preventing MTCT of HBV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>telbivudine</intervention_name>
    <description>in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B.&#xD;
in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.</description>
    <arm_group_label>telbivudine treated entire pregnancy</arm_group_label>
    <arm_group_label>telbivudine treated in late pregnancy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        this study would enroll 600 HBsAg positive mothers, including 240 cases with high serum HBV&#xD;
        DNA load during pregnancy, 120 cases treated with antiviral therapy for hepatitis B, 120&#xD;
        cases with HBV DNA negative during pregnancy, 120 cases with high serum HBV DNA but receive&#xD;
        antiviral therapy in late of pregnancy, and all of their infants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants born to HBsAg positive mother HBsAg positive mother&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mothers coinfected HIV or HCV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Yi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Ditan Hospital</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Ditan Hospital</investigator_affiliation>
    <investigator_full_name>Wei Yi</investigator_full_name>
    <investigator_title>The department of obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>Mother-to-child transmission</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Telbivudine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02253485
org study id: D121100003912001
nct id: NCT02253485
lead sponsor: 
has dmc: Yes
Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV)
      infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born
      to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is
      evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg
      positive mothers with high serum HBV DNA loads.
This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg
      positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis(
      injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a
      HBsAg positive mother with high HBV DNA load before delivery, and based on standard
      immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ)
      infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral
      therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg
      positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive
      standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA
      negative receive standard immunoprophylaxis.
observational model: Case-Control
time perspective: Prospective
measure: mother-to-child transmission of HBV
time frame: 7 months
description: HBV infenction in infants at 7 months after birth
arm group label: telbivudine treated entire pregnancy
description: mothers in this group were treated with antiviral therapy during entire pregnancy for hepatitis, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.
arm group label: telbivudine treated in late pregnancy
description: mothers with high serum HBV DNA load were treated with antiviral therapy in late pregnancy, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.
arm group label: HBV DNA positive control
description: infants in this group born to mother with high serum HBV DNA load and receive standard immunoprophylaxis or additional HBIG injection at 1 month after birth for preventing MTCT of HBV.
arm group label: HBV DNA negative control
description: infants in this group born to a HBsAg positive and serum HBV DNA negative mothers and receive standard immunoprophylaxis for preventing MTCT of HBV
intervention type: Drug
intervention name: telbivudine
description: in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B.
in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.
arm group label: telbivudine treated entire pregnancy
arm group label: telbivudine treated in late pregnancy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Months
healthy volunteers: No
last name: Wei Yi
role: Principal Investigator
affiliation: Beijing Ditan Hospital
responsible party type: Principal Investigator
investigator affiliation: Beijing Ditan Hospital
investigator full name: Wei Yi
investigator title: The department of obstetrics and gynecology
mesh term: Telbivudine