<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/NCT04507607</url>
  </required_header>
  <id_info>
    <org_study_id>0237801</org_study_id>
    <nct_id>NCT04507607</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection</brief_title>
  <official_title>Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later&#xD;
      stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral&#xD;
      drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in&#xD;
      preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF&#xD;
      for CHB the curative effect of pregnant and postnatal security.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen&#xD;
      University, the eligible patients were enrolled into the group.Each person will sign the&#xD;
      informed consent prior to enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Liver indicators of intrapartum</measure>
    <time_frame>intrapartum</time_frame>
    <description>The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver indicators of postpartum</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women 1 month、3 month、7 month、9 month、12 month after delivery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Liver indicators of pregnancy</measure>
    <time_frame>24 weeks gestation until delivery</time_frame>
    <description>The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women taking TAF 0、4、8、12 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <condition>Mother-to-child Block</condition>
  <condition>Antiviral Treatment</condition>
  <arm_group>
    <arm_group_label>Pregnant women with CHB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>women with CHB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir Alafenamide 25 MG</intervention_name>
    <description>TAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment.</description>
    <arm_group_label>Pregnant women with CHB</arm_group_label>
    <arm_group_label>women with CHB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  25 pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic&#xD;
             criteria in the guidelines for the prevention and treatment of chronic hepatitis B&#xD;
             were pregnant women at 24-28 weeks of pregnancy.&#xD;
&#xD;
          -  25 non-pregnant women with HBeAg (+), HBV DNA ≥ 2*10^6IU/mL who met the diagnostic&#xD;
             criteria in the guidelines for the prevention and treatment of chronic hepatitis B.&#xD;
&#xD;
          -  The enrolled patients were all newly admitted patients without treatment, and if they&#xD;
             did not meet the standard after completing the relevant examination, they would be&#xD;
             removed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coinfection with HAV, HCV, HDV, HEV or HIV;&#xD;
&#xD;
          -  A history of antiviral therapy or concurrent treatment with immunoregulatory drugs,&#xD;
             antitumor drugs, cytotoxic drugs or immunosuppressive steroids;&#xD;
&#xD;
          -  Three-dimensional ultrasonography showed fetal malformation;&#xD;
&#xD;
          -  The spouse is infected with HBV;&#xD;
&#xD;
          -  History of decompensated liver disease (e.g., decompensated liver disease with&#xD;
             coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia,&#xD;
             ascites and esophageal varicose bleeding), history of liver cancer or other chronic&#xD;
             liver disease (e.g., autoimmune hepatitis) or clinical symptoms;&#xD;
&#xD;
          -  History of immune diseases;&#xD;
&#xD;
          -  A history of serious cardiovascular disease;&#xD;
&#xD;
          -  Other reasons the researchers considered it inappropriate to participate in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>LinChaoshuang</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LiXin Xiao</last_name>
      <phone>18613016355</phone>
      <email>amia1995@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Chaoshuang Lin</investigator_full_name>
    <investigator_title>Professor Lin</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</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/NCT04507607
org study id: 0237801
nct id: NCT04507607
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later
      stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral
      drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in
      preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF
      for CHB the curative effect of pregnant and postnatal security.
After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen
      University, the eligible patients were enrolled into the group.Each person will sign the
      informed consent prior to enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Liver indicators of intrapartum
time frame: intrapartum
description: The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women at birth.
measure: Liver indicators of postpartum
time frame: 12 months postpartum
description: The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women 1 month、3 month、7 month、9 month、12 month after delivery.
measure: Liver indicators of pregnancy
time frame: 24 weeks gestation until delivery
description: The level of liver function (ALT、AST)、HBV DNA、HBV Serological markers (HBsAg、HBeAg、HBeAb) in pregnant women taking TAF 0、4、8、12 weeks.
arm group label: Pregnant women with CHB
arm group type: Experimental
description: Start taking TAF at 24 weeks of gestation until delivery. The liver function, viral load and antigen status were reviewed monthly and 10 ml peripheral blood was collected.
arm group label: women with CHB
arm group type: Active Comparator
description: Nonpregnant women taking TAF for antiviral therapy were regularly rechecked for liver function, viral load, and antigens.
intervention type: Drug
intervention name: Tenofovir Alafenamide 25 MG
description: TAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment.
arm group label: Pregnant women with CHB
arm group label: women with CHB
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Affiliated Hospital, Sun Yat-Sen University
investigator full name: Chaoshuang Lin
investigator title: Professor Lin
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Tenofovir