<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/NCT01730508</url>
  </required_header>
  <id_info>
    <org_study_id>ML28516</org_study_id>
    <nct_id>NCT01730508</nct_id>
  </id_info>
  <brief_title>An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B</brief_title>
  <official_title>A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multicenter, prospective, observational study will evaluate the use in clinical practice&#xD;
      and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with&#xD;
      HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local&#xD;
      label will be followed for the duration of their treatment and for one year after cessation&#xD;
      of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2012</start_date>
  <completion_date type="Actual">June 25, 2017</completion_date>
  <primary_completion_date type="Actual">June 25, 2017</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>Incidence of sustained suppression of HBV DNA &lt;2000 IU/mL one year after treatment cessation</measure>
    <time_frame>approximately 4 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of suppression of HBV DNA &lt;2000 IU/mL at the end of treatment and 6 months post-treatment</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of HBV DNA undetectable (&lt;400 IU/mL) at the end of treatment and 1 year post-treatment</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of HBsAg loss/seroconversion</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of normalization of serum ALT levels</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage/schedule of Pegasys treatment in real-life clinical setting</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical/demographic patient characteristics at initiation of treatment</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">978</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>Chronic Hepatitis B Participants</arm_group_label>
    <description>Hepatitis B e antigen (HBeAg) chronic hepatitis B (CHB) participants who received treatment with pegylated interferon alfa (peginterferon alfa) according to China labeling and China standard of care and were followed up to 1 year after treatment cessation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegylated Interferon Alfa (Peginterferon Alfa)</intervention_name>
    <description>Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.</description>
    <arm_group_label>Chronic Hepatitis B Participants</arm_group_label>
    <other_name>Pegasys</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese participants with HBeAg negative chronic hepatitis B receiving treatment with&#xD;
        Pegasys&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult participants, &gt;/= 18 years of age&#xD;
&#xD;
          -  Treatment with Pegasys according to label and standard clinical practice&#xD;
&#xD;
          -  HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis&#xD;
&#xD;
          -  Serum alanine aminotransferase (ALT) &gt; upper limit of normal (ULN) but &lt;/= 10 x ULN&#xD;
&#xD;
          -  Hepatitis B Virus (HBV) DNA &gt;/= 2000 IU/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to Pegasys as detailed in the label&#xD;
&#xD;
          -  Co-infection with hepatitis A, hepatitis C or HIV&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Participants should not receive concomitant therapy with telbivudine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Fifth Hospital of Shijiazhuang</name>
      <address>
        <city>Baoding</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Ditan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing 302 Hospital; No. 2 Infectious Disease Section</name>
      <address>
        <city>Beijing</city>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing You An Hospital; Digestive Dept</name>
      <address>
        <city>Beijing</city>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Union Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Hepatobiliary Hospital</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peoples Hospital of Hunan Province</name>
      <address>
        <city>Changsha</city>
        <zip>410007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital Of Central South University</name>
      <address>
        <city>Changsha</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changzhou 3rd People's Hospital</name>
      <address>
        <city>Changzhou</city>
        <zip>213001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital, Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <zip>400016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Hospital , Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>6th Hospital of Dalian City</name>
      <address>
        <city>Dalian</city>
        <zip>116031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Foshan</name>
      <address>
        <city>Foshan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Shunde</name>
      <address>
        <city>Foushan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuzhou Infectious Diseases Hospital</name>
      <address>
        <city>Fuzhou</city>
        <zip>350025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou City</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eighth People's Hospital of Guangzhou</name>
      <address>
        <city>Guangzhou</city>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou First Municipal People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou University of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <zip>510405</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital, Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Jinan University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial Traditional Chinese Medicine Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan provincial people's hospital</name>
      <address>
        <city>Haikou</city>
        <zip>570311</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of College of Medicine, Zhejiang University(First Hospital of Zhejiang</name>
      <address>
        <city>Hangzhou</city>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Hangzhou Normal University</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>211 Military Hospital of China</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 4th Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huai'an No 4 People's Hospital</name>
      <address>
        <city>Huai'an</city>
        <zip>223001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangmen Wuyi Traditional Chinese Medicine Hospital</name>
      <address>
        <city>Jiangmen</city>
        <zip>529000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangyin People's Hospital</name>
      <address>
        <city>Jiangyin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jinan Infectious Diseases Hospital</name>
      <address>
        <city>Jinan</city>
        <zip>250021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Third people's Hospital of Kunming City</name>
      <address>
        <city>Kunming</city>
        <zip>650041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Gansu Province General Hospital</name>
      <address>
        <city>Lanzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Lian Yun Gang</name>
      <address>
        <city>Lianyungang</city>
        <zip>222002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liuzhou Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Liuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Luzhou medical college</name>
      <address>
        <city>LuZhou</city>
        <zip>646000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ninth Hospital of Nanchang</name>
      <address>
        <city>Nanchang</city>
        <zip>330002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing No.2 Hospital; Liver Disease Department</name>
      <address>
        <city>Nanjing</city>
        <zip>210003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <zip>210036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 81st Hospital of P.L.A.</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine</name>
      <address>
        <city>Nanning</city>
        <zip>530011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliate Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ningbo No.2 Hospital</name>
      <address>
        <city>Ningbo</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordos No.2 Hospital</name>
      <address>
        <city>Ordos</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QingDao Infection Diseases Hospital</name>
      <address>
        <city>Qingdao</city>
        <zip>266033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Public Health Clinical Center</name>
      <address>
        <city>Shanghai</city>
        <zip>201508</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No.3 people's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>201999</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longhua Hospital, Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Huangpu District Central Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Shantou University</name>
      <address>
        <city>Shantou</city>
        <zip>515041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Donghu Hospital</name>
      <address>
        <city>Shen Zhen</city>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>ShenYang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenyang Sixth People's Hospital （Shenyang Infectious Disease Hospital）</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethune International Peace Hospital of PLA</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050082</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suining Central Hospital</name>
      <address>
        <city>Suining</city>
        <zip>629000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fifth People's Hospital Suzhou; Infectious Disease</name>
      <address>
        <city>Suzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Hospital of Taiyuan (Taiyuan Infectious Diseases Hospital)</name>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Taizhou People's Hospital</name>
      <address>
        <city>Taizhou</city>
        <zip>225300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Infectious Disease Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300192</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dagang Oil Field General Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine</name>
      <address>
        <city>Urumqi</city>
        <zip>830001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Teaching Hospital of Xinjiang Medical University</name>
      <address>
        <city>Urumqi</city>
        <zip>830054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenzhou Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Wenzhou</city>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruian People's Hospital</name>
      <address>
        <city>Wenzhou</city>
        <zip>325200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. &amp; Tech</name>
      <address>
        <city>Wuhan</city>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuxi No.5 People's Hospital</name>
      <address>
        <city>Wuxi</city>
        <zip>214005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)</name>
      <address>
        <city>Xi'an</city>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiamen Hospital of T.C.M</name>
      <address>
        <city>Xiamen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xingtai People's Hospital</name>
      <address>
        <city>Xingtai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical College</name>
      <address>
        <city>Xuzhou</city>
        <zip>221004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yancheng City No.1 People's Hospital</name>
      <address>
        <city>Yancheng</city>
        <zip>224005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yangzhou Third People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <zip>225009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central People's Hospital of Yichang</name>
      <address>
        <city>Yichang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese medicine hospital of Zhaoqing City</name>
      <address>
        <city>Zhaoqing</city>
        <zip>526020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhenjiang Third People's Hospital</name>
      <address>
        <city>Zhenjiang</city>
        <zip>212005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhoushan Hospital</name>
      <address>
        <city>Zhoushan</city>
        <zip>316000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhuhai People's Hospital</name>
      <address>
        <city>Zhuhai</city>
        <zip>519099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>July 13, 2017</last_update_submitted>
  <last_update_submitted_qc>July 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-alpha</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/NCT01730508
org study id: ML28516
nct id: NCT01730508
lead sponsor: 
This multicenter, prospective, observational study will evaluate the use in clinical practice
      and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with
      HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local
      label will be followed for the duration of their treatment and for one year after cessation
      of treatment.
observational model: Cohort
time perspective: Prospective
measure: Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
time frame: approximately 4 years
measure: Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment
time frame: approximately 4 years
measure: Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment
time frame: approximately 4 years
measure: Incidence of HBsAg loss/seroconversion
time frame: approximately 4 years
measure: Incidence of normalization of serum ALT levels
time frame: approximately 4 years
measure: Dosage/schedule of Pegasys treatment in real-life clinical setting
time frame: approximately 4 years
measure: Clinical/demographic patient characteristics at initiation of treatment
time frame: approximately 4 years
measure: Safety: Incidence of adverse events
time frame: approximately 4 years
arm group label: Chronic Hepatitis B Participants
description: Hepatitis B e antigen (HBeAg) chronic hepatitis B (CHB) participants who received treatment with pegylated interferon alfa (peginterferon alfa) according to China labeling and China standard of care and were followed up to 1 year after treatment cessation.
intervention type: Drug
intervention name: Pegylated Interferon Alfa (Peginterferon Alfa)
description: Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.
arm group label: Chronic Hepatitis B Participants
other name: Pegasys
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Interferons
mesh term: Interferon-alpha