<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/NCT02974829</url>
  </required_header>
  <id_info>
    <org_study_id>AI463520</org_study_id>
    <nct_id>NCT02974829</nct_id>
  </id_info>
  <brief_title>REALM China Extension Study</brief_title>
  <official_title>A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to conduct an investigator initiated observational study to&#xD;
      continue to follow up the China subset of study participants for another 5 years after they&#xD;
      complete participation in the REALM Study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <primary_completion_date type="Anticipated">January 2022</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>Treatment patterns in Study AI463520</measure>
    <time_frame>year 5</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rates of hepatitis B virus (HBV)-related clinical outcome events (COEs), such as non-hepatocellular carcinoma (HCC) HBV progression, HCC, and liver-related mortality, in Studies AI463080 and AI463520 combined, and in Study AI463520.</measure>
    <time_frame>year 5</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.</measure>
    <time_frame>year 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study</measure>
    <time_frame>year 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520.</measure>
    <time_frame>year 5</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>All patients</arm_group_label>
    <description>Continuing with marketed anti-HBV or off-treatment in real-life setting</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>follow-up</intervention_name>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic hepatitis B patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients completed REALM Study in China&#xD;
&#xD;
          2. Patients willing to sign the consent to continue anti-viral treatment or&#xD;
             post-treatment follow up, and agree his/her legacy data and blood/liver histology&#xD;
             samples collected in REALM Study may be used for the analyses planned for this new&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who do not provide consent to participate in this study;&#xD;
&#xD;
          2. Patients are formally enrolled into any investigational drug clinical trial after the&#xD;
             REALM study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huafa Yin</last_name>
      <email>yhf163.good@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>302 Military Hospital Of China</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinghua Hu</last_name>
      <email>hjh@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Ditan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Cheng</last_name>
      <email>jun.cheng.ditan@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Ma</last_name>
      <email>mahongmd@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Beijing University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lai Wei, MD</last_name>
      <email>weelai@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated of ChongQing University of Medical Science</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Ren</last_name>
      <email>renhong0531@vip.sina.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>GuangZhou No. 8 People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Min Xu</last_name>
      <email>gz8hxm@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinlin Hou</last_name>
      <email>jlhousmu@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Third Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dongying Xie</last_name>
      <email>xdy-gz@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Guiyang Medical College</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mingliang Cheng</last_name>
      <email>chengml@21cn.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>People's hospital of Hainan Province</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Lin</last_name>
      <email>lin_fenghn@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zujiang Yu</last_name>
      <email>johnyuem@zzu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical Science Research Institute of Henan Province</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aimin Sun</last_name>
      <email>aiminsunzz@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Henan Province</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jia Shang</last_name>
      <email>shangjia666@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital of Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhengang Zhang</last_name>
      <email>zhangzhg@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongfang Jiang</last_name>
      <email>jiangyongfang@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deming Tan</last_name>
      <email>dmt3008@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>No.81 Hospital of PLA</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maorong Wang</last_name>
      <email>maorongwang@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The second hospital of nanjing</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Zhao</last_name>
      <email>zhaohong6401@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ningbo infectious disease hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hao Ying</last_name>
      <email>yinghao66@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianhe Gan</last_name>
      <email>ganjianhe@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>People's hospital of Jiangsu Province</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donghui Zhou</last_name>
      <email>dr-zhou@vip.sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Hospital of Jilin Unniversity</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junqi Niu</last_name>
      <email>junqiniu@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>No.6 People's hospital of Dalian</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gongchen Wang</last_name>
      <email>wgc8602@sohu.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ShengJing Hospital of China Medical University</name>
      <address>
        <city>Shengyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoguang Dou</last_name>
      <email>guang40@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>No.6 People's hospital of Shenyang</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mingxiang Zhang</last_name>
      <email>zmx6511@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianqi Lian</last_name>
      <email>lianjq@fmmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shumei Lin</last_name>
      <email>linshumei123@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinan infectious disease hospital</name>
      <address>
        <city>Jinan Shi</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qiang Li</last_name>
      <email>doctorliqiang@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>No.85 Hospital of PLA</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chengwei Chen</last_name>
      <email>ccw2@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qing Xie</last_name>
      <email>xieqingrjh@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Longfeng Zhao</last_name>
      <email>zhaolf006@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital of SiChuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Tang</last_name>
      <email>htang6198@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of kunming medical college</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wu Li</last_name>
      <email>liwukm@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhejing University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qi Xia</last_name>
      <email>xiaqi1980@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hangzhou No.6 people's hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huimin Liu</last_name>
      <email>1557585971@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huazhong Chen</last_name>
      <email>docchz@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Beijing University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoyuan Xu</last_name>
      <email>xiaoyuanxu6@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>You An Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhongping Duan</last_name>
      <email>duan2517@sohu.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southwest Hospital Affiliated the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jijun Zhou</last_name>
      <email>13883088455@139.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital of the Second Military Medical University of Chinese PLA</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chengzhong Li</last_name>
      <email>leo_lee66@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huashan hospital of fudan university</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenhong Zhang</last_name>
      <email>zhangwenhong@fudan.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Renji Hospital of Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yimin Mao</last_name>
      <email>maoym11968@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai jing 'an district central hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Wang</last_name>
      <email>13501762950@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai No.5 People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Desheng Xie</last_name>
      <email>deshengxie@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Public Health Clinical Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiefei Wang</last_name>
      <email>wjf_sm@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuncai Zhang</last_name>
      <email>doctorzhangsc@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>No.3 people's hospital of shenzhen</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feijian Ao</last_name>
      <email>szaofj@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin infectious disease hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuqiang Mi</last_name>
      <email>yuqiangmi68@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin third central hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tao Han</last_name>
      <email>hantaomd@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 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 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hepatitis B</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02974829
org study id: AI463520
nct id: NCT02974829
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to conduct an investigator initiated observational study to
      continue to follow up the China subset of study participants for another 5 years after they
      complete participation in the REALM Study
observational model: Cohort
time perspective: Prospective
measure: Treatment patterns in Study AI463520
time frame: year 5
measure: Incidence rates of hepatitis B virus (HBV)-related clinical outcome events (COEs), such as non-hepatocellular carcinoma (HCC) HBV progression, HCC, and liver-related mortality, in Studies AI463080 and AI463520 combined, and in Study AI463520.
time frame: year 5
measure: Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.
time frame: year 5
measure: Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study
time frame: year 5
measure: Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520.
time frame: year 5
arm group label: All patients
description: Continuing with marketed anti-HBV or off-treatment in real-life setting
intervention type: Other
intervention name: follow-up
arm group label: All patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
sharing ipd: Undecided