<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/NCT02973646</url>
  </required_header>
  <id_info>
    <org_study_id>PL2</org_study_id>
    <nct_id>NCT02973646</nct_id>
  </id_info>
  <brief_title>Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection</brief_title>
  <official_title>Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor</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>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic&#xD;
      hepatitis b patients with e antigen positive based on the detection of interferon gene&#xD;
      mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex,&#xD;
      symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also&#xD;
      observed the laboratory test results including the levels of white blood cells (WBC), red&#xD;
      blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate&#xD;
      transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg),&#xD;
      hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation&#xD;
      (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>good virologic response</measure>
    <time_frame>24th week</time_frame>
    <description>level of HBsAg is less than or equal to 1500 IU/ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>common virologic response</measure>
    <time_frame>24th week</time_frame>
    <description>level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bad virologic response</measure>
    <time_frame>24th week</time_frame>
    <description>level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Hepatitis b</condition>
  <arm_group>
    <arm_group_label>Nucleos(t)ide analogues treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peginterferon treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entecavir or Tenofovir</intervention_name>
    <description>Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.</description>
    <arm_group_label>Nucleos(t)ide analogues treatment</arm_group_label>
    <other_name>Baraclude</other_name>
    <other_name>Viread</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon Alfa-2B</intervention_name>
    <arm_group_label>Nucleos(t)ide analogues treatment</arm_group_label>
    <arm_group_label>Peginterferon treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronic hepatitis b Patients who should receive anti-HBV therapy according to&#xD;
             guideline and are willing to receive interferon therapy;&#xD;
&#xD;
          2. Hepatitis B e antigen positive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients received anti-HBV therapy in the past 6 months;&#xD;
&#xD;
          2. Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;&#xD;
&#xD;
          3. Patients with other factors causing active liver diseases;&#xD;
&#xD;
          4. Pregnancy or lactation women;&#xD;
&#xD;
          5. Patients with HIV infection or congenital immune deficiency diseases;&#xD;
&#xD;
          6. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions&#xD;
             and other serious complications.&#xD;
&#xD;
          7. Patients with other reasons not suitable to receive interferon therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liang Peng, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Third Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wenxiong Xu, Master</last_name>
    <phone>+8613760783281</phone>
    <email>xwx1983@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Liang Peng, Doctor</last_name>
    <phone>+8613533978874</phone>
    <email>pzp33@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Third Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang Peng, Doctor</last_name>
      <phone>+8613533978874</phone>
      <email>pzp33@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</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>Liang Peng</investigator_full_name>
    <investigator_title>Associated Professor</investigator_title>
  </responsible_party>
  <keyword>chronic hepatitis b</keyword>
  <keyword>peginterferon alfa-2b</keyword>
  <keyword>interferon gene mutation</keyword>
  <keyword>interferon receptor</keyword>
  <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>
    <mesh_term>Entecavir</mesh_term>
    <mesh_term>Peginterferon alfa-2b</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/NCT02973646
org study id: PL2
nct id: NCT02973646
lead sponsor: 
has dmc: Yes
The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic
      hepatitis b patients with e antigen positive based on the detection of interferon gene
      mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.
Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex,
      symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also
      observed the laboratory test results including the levels of white blood cells (WBC), red
      blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate
      transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg),
      hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation
      (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: good virologic response
time frame: 24th week
description: level of HBsAg is less than or equal to 1500 IU/ml
measure: common virologic response
time frame: 24th week
description: level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml
measure: bad virologic response
time frame: 24th week
description: level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 IU/ml
arm group label: Nucleos(t)ide analogues treatment
arm group type: Experimental
description: Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.
arm group label: Peginterferon treatment
arm group type: Active Comparator
description: Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.
intervention type: Drug
intervention name: Entecavir or Tenofovir
description: Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.
arm group label: Nucleos(t)ide analogues treatment
other name: Baraclude
other name: Viread
intervention type: Drug
intervention name: Peginterferon Alfa-2B
arm group label: Nucleos(t)ide analogues treatment
arm group label: Peginterferon treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Liang Peng, Doctor
role: Principal Investigator
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
last name: Wenxiong Xu, Master
phone: +8613760783281
email: xwx1983@163.com
last name: Liang Peng, Doctor
phone: +8613533978874
email: pzp33@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Affiliated Hospital, Sun Yat-Sen University
investigator full name: Liang Peng
investigator title: Associated Professor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Tenofovir
mesh term: Entecavir
mesh term: Peginterferon alfa-2b