xml: <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/NCT05965388</url>
    </required_header>
    <id_info>
      <org_study_id>COMPASS by REASON</org_study_id>
      <nct_id>NCT05965388</nct_id>
    </id_info>
    <brief_title>Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy</brief_title>
    <official_title>Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wen-hong Zhang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shandong Provincial Hospital Affiliated to Shandong First Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Affiliated Hospital of Xuzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Fujian Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Third People's Hospital of Taiyuan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First People's Hospital of Yunnan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Anhui Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Huashan Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this prospective, exploratory, non-intervention, multi-center, real-world study&#xD;
        is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes&#xD;
        under antiviral therapy in patients with chronic hepatitis B.&#xD;
  &#xD;
        Participants will take the necessary clinical examination and blood draw during the patient's&#xD;
        treatment and follow-up, and all the treatment is determined by clinicians.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, exploratory, multi-center, real-world study, with Huashan&#xD;
        Hospital as the leading unit. The study includes patients with chronic hepatitis B who have&#xD;
        been determined by clinicians to start, or have already taken the first-line treatment {&#xD;
        including pegylated interferon [IFN] monotherapy, a potent nucleos(t)ide analogue [NA]&#xD;
        monotherapy, two different potent NAs combination therapy, or NA plus IFN combination&#xD;
        therapy. The study only collects clinical data and serum samples, without imposing any&#xD;
        additional intervention measures or affecting any relevant clinical decisions. The clinical&#xD;
        data is collected from the patient's clinical follow-up examination data, without additional&#xD;
        visits and auxiliary examinations. Sample collection During the necessary clinical&#xD;
        examination and blood draw during the patient's treatment and follow-up, one additional serum&#xD;
        separation tube (3ml) was drawn, without additional invasive examination for the patient. The&#xD;
        study will follow up with patients for 5 years to explore the relationship between the serum&#xD;
        HBV pgRNA level and the endpoint event at different time points.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2029</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>Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period</measure>
      <time_frame>5 years</time_frame>
      <description>Number of Participants with Diagnosis of hepatocellular carcinoma</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period</measure>
      <time_frame>Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240</time_frame>
      <description>Number of Participants with Diagnosis of participants with decompensation cirrhosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Diagnosis of participants with liver transplantation during the observation period</measure>
      <time_frame>Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240</time_frame>
      <description>Number of Participants with Diagnosis of participants with liver transplantation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period</measure>
      <time_frame>Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240</time_frame>
      <description>Number of Participants with Diagnosis of participants with fibrosis regression and progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Diagnosis of participants with serological response during the observation period</measure>
      <time_frame>Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240</time_frame>
      <description>Hepatitis B s Antigen (HBsAg) Loss, seroconversion to HBsAg, Hepatitis B s Antigen (HBeAg) Loss (only patients who are HBeAg positive at baseline), and seroconversion to HBeAg</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>HBV</condition>
    <condition>HCC</condition>
    <arm_group>
      <arm_group_label>Chronic hepatitis B patients treated with nucleoside analogues or interferon</arm_group_label>
      <description>Chronic hepatitis B patients treated with nucleoside analogues or interferon</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>nucleoside analogues or interferon</intervention_name>
      <description>ETV、TDF、TAF、TAF、IFN-a-2b</description>
      <arm_group_label>Chronic hepatitis B patients treated with nucleoside analogues or interferon</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Collect the serum samples of CHB patients receiving antiviral therapy during long-term&#xD;
        follow-up, and detect the concentration of HBV pgRNA in the samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with chronic hepatitis B who have been determined by clinicians to start, or have&#xD;
          already taken the first-line treatment {including pegylated interferon [IFN] monotherapy, a&#xD;
          potent nucleos(t)ide analogue [NA] monotherapy, two different potent NAs combination&#xD;
          therapy, or NA plus IFN combination therapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related&#xD;
               histological changes within 1 year if HBsAg positive less than 6 months;&#xD;
  &#xD;
            -  Age between 18-80 years, gender is not limited；&#xD;
  &#xD;
            -  Patients with chronic hepatitis B who have been determined by clinicians to start, or&#xD;
               have already taken the first-line treatment {including pegylated interferon [IFN]&#xD;
               monotherapy, a potent nucleos(t)ide analogue [NA] monotherapy, two different potent&#xD;
               NAs combination therapy, or NA plus IFN combination therapy;&#xD;
  &#xD;
            -  Patient who reads and signs informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with malignancies other than hepatocellular carcinoma.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wenhong Zhang, MD</last_name>
      <phone>13801844344</phone>
      <email>zhangwenhong@fudan.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Anhui Medical University</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230022</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ying Ye</last_name>
        <phone>13856980361</phone>
        <email>yeying2@139.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Fujian Medical University</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350004</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yuekai Hu, M.D.</last_name>
        <phone>13564579738</phone>
        <email>746896522@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Jiangsu Province Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>the Affiliated Hosptial of Xuzhou Medical University</name>
        <address>
          <city>Xuzhou</city>
          <state>Jiangsu</state>
          <zip>221000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xuebing Yan, M.D.</last_name>
        <phone>15205215685</phone>
        <email>yxbxuzhou@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shandong Provincial Hospital of Shandong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wanhua Ren</last_name>
        <email>ganbingzx@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Third People's Hospital of Taiyuan</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ying Guo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>First Affiliated Hospital Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yingli He, M.D.</last_name>
        <phone>18991232863</phone>
        <email>heyingli2000@mail.xjtu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital Of YunNan</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650100</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jiawei Geng, M.D.</last_name>
        <phone>13888757766</phone>
        <email>746896522@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Huashan Hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wenhong Zhang, Professor</last_name>
        <phone>13801844344</phone>
        <email>zhangwenhong@fudan.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Feng Sun, doctor</last_name>
        <phone>15921403893</phone>
        <email>aaronsf1125@126.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.</citation>
      <PMID>26231459</PMID>
    </reference>
    <reference>
      <citation>Chinese Society of Infectious Diseases, Chinese Medical Association; Chinese Society of Hepatology, Chinese Medical Association. [The guidelines of prevention and treatment for chronic hepatitis B (2019 version)]. Zhonghua Gan Zang Bing Za Zhi. 2019 Dec 20;27(12):938-961. doi: 10.3760/cma.j.issn.1007-3418.2019.12.007. Chinese.</citation>
      <PMID>31941257</PMID>
    </reference>
    <reference>
      <citation>Jung MC, Pape GR. Immunology of hepatitis B infection. Lancet Infect Dis. 2002 Jan;2(1):43-50. doi: 10.1016/s1473-3099(01)00172-4.</citation>
      <PMID>11892495</PMID>
    </reference>
    <reference>
      <citation>Shin EC, Sung PS, Park SH. Immune responses and immunopathology in acute and chronic viral hepatitis. Nat Rev Immunol. 2016 Aug;16(8):509-23. doi: 10.1038/nri.2016.69. Epub 2016 Jul 4.</citation>
      <PMID>27374637</PMID>
    </reference>
    <reference>
      <citation>Nassal M. HBV cccDNA: viral persistence reservoir and key obstacle for a cure of chronic hepatitis B. Gut. 2015 Dec;64(12):1972-84. doi: 10.1136/gutjnl-2015-309809. Epub 2015 Jun 5.</citation>
      <PMID>26048673</PMID>
    </reference>
    <reference>
      <citation>Pollicino T, Belloni L, Raffa G, Pediconi N, Squadrito G, Raimondo G, Levrero M. Hepatitis B virus replication is regulated by the acetylation status of hepatitis B virus cccDNA-bound H3 and H4 histones. Gastroenterology. 2006 Mar;130(3):823-37. doi: 10.1053/j.gastro.2006.01.001.</citation>
      <PMID>16530522</PMID>
    </reference>
    <reference>
      <citation>Ko C, Chakraborty A, Chou WM, Hasreiter J, Wettengel JM, Stadler D, Bester R, Asen T, Zhang K, Wisskirchen K, McKeating JA, Ryu WS, Protzer U. Hepatitis B virus genome recycling and de novo secondary infection events maintain stable cccDNA levels. J Hepatol. 2018 Dec;69(6):1231-1241. doi: 10.1016/j.jhep.2018.08.012. Epub 2018 Aug 22.</citation>
      <PMID>30142426</PMID>
    </reference>
    <reference>
      <citation>Tang LSY, Covert E, Wilson E, Kottilil S. Chronic Hepatitis B Infection: A Review. JAMA. 2018 May 1;319(17):1802-1813. doi: 10.1001/jama.2018.3795. Erratum In: JAMA. 2018 Sep 18;320(11):1202.</citation>
      <PMID>29715359</PMID>
    </reference>
    <reference>
      <citation>Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.</citation>
      <PMID>29405329</PMID>
    </reference>
    <reference>
      <citation>European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.</citation>
      <PMID>28427875</PMID>
    </reference>
    <reference>
      <citation>Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15.</citation>
      <PMID>28620797</PMID>
    </reference>
    <reference>
      <citation>Kim GA, Lim YS, An J, Lee D, Shim JH, Kim KM, Lee HC, Chung YH, Lee YS, Suh DJ. HBsAg seroclearance after nucleoside analogue therapy in patients with chronic hepatitis B: clinical outcomes and durability. Gut. 2014 Aug;63(8):1325-32. doi: 10.1136/gutjnl-2013-305517. Epub 2013 Oct 25.</citation>
      <PMID>24162593</PMID>
    </reference>
    <reference>
      <citation>Lim TH, Gane E, Moyes C, Borman B, Cunningham C. HBsAg loss in a New Zealand community study with 28-year follow-up: rates, predictors and long-term outcomes. Hepatol Int. 2016 Sep;10(5):829-37. doi: 10.1007/s12072-016-9709-6. Epub 2016 Mar 8.</citation>
      <PMID>26957439</PMID>
    </reference>
    <reference>
      <citation>Wang YX, Niklasch M, Liu T, Wang Y, Shi B, Yuan W, Baumert TF, Yuan Z, Tong S, Nassal M, Wen YM. Interferon-inducible MX2 is a host restriction factor of hepatitis B virus replication. J Hepatol. 2020 May;72(5):865-876. doi: 10.1016/j.jhep.2019.12.009. Epub 2019 Dec 18.</citation>
      <PMID>31863794</PMID>
    </reference>
    <reference>
      <citation>Tan G, Yi Z, Song H, Xu F, Li F, Aliyari R, Zhang H, Du P, Ding Y, Niu J, Wang X, Su L, Qin FX, Cheng G. Type-I-IFN-Stimulated Gene TRIM5gamma Inhibits HBV Replication by Promoting HBx Degradation. Cell Rep. 2019 Dec 10;29(11):3551-3563.e3. doi: 10.1016/j.celrep.2019.11.041.</citation>
      <PMID>31825835</PMID>
    </reference>
    <reference>
      <citation>Sadler AJ, Williams BR. Interferon-inducible antiviral effectors. Nat Rev Immunol. 2008 Jul;8(7):559-68. doi: 10.1038/nri2314.</citation>
      <PMID>18575461</PMID>
    </reference>
    <reference>
      <citation>Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.</citation>
      <PMID>26453773</PMID>
    </reference>
    <reference>
      <citation>Reijnders JG, Rijckborst V, Sonneveld MJ, Scherbeijn SM, Boucher CA, Hansen BE, Janssen HL. Kinetics of hepatitis B surface antigen differ between treatment with peginterferon and entecavir. J Hepatol. 2011 Mar;54(3):449-54. doi: 10.1016/j.jhep.2010.07.046. Epub 2010 Nov 5.</citation>
      <PMID>21112655</PMID>
    </reference>
    <reference>
      <citation>Wursthorn K, Lutgehetmann M, Dandri M, Volz T, Buggisch P, Zollner B, Longerich T, Schirmacher P, Metzler F, Zankel M, Fischer C, Currie G, Brosgart C, Petersen J. Peginterferon alpha-2b plus adefovir induce strong cccDNA decline and HBsAg reduction in patients with chronic hepatitis B. Hepatology. 2006 Sep;44(3):675-84. doi: 10.1002/hep.21282.</citation>
      <PMID>16941693</PMID>
    </reference>
    <reference>
      <citation>van Bommel F, van Bommel A, Krauel A, Wat C, Pavlovic V, Yang L, Deichsel D, Berg T, Bohm S. Serum HBV RNA as a Predictor of Peginterferon Alfa-2a Response in Patients With HBeAg-Positive Chronic Hepatitis B. J Infect Dis. 2018 Aug 24;218(7):1066-1074. doi: 10.1093/infdis/jiy270.</citation>
      <PMID>29741634</PMID>
    </reference>
    <reference>
      <citation>Huang YW, Takahashi S, Tsuge M, Chen CL, Wang TC, Abe H, Hu JT, Chen DS, Yang SS, Chayama K, Kao JH. On-treatment low serum HBV RNA level predicts initial virological response in chronic hepatitis B patients receiving nucleoside analogue therapy. Antivir Ther. 2015;20(4):369-75. doi: 10.3851/IMP2777. Epub 2014 Apr 16.</citation>
      <PMID>24739420</PMID>
    </reference>
    <reference>
      <citation>Jansen L, Kootstra NA, van Dort KA, Takkenberg RB, Reesink HW, Zaaijer HL. Hepatitis B Virus Pregenomic RNA Is Present in Virions in Plasma and Is Associated With a Response to Pegylated Interferon Alfa-2a and Nucleos(t)ide Analogues. J Infect Dis. 2016 Jan 15;213(2):224-32. doi: 10.1093/infdis/jiv397. Epub 2015 Jul 27.</citation>
      <PMID>26216905</PMID>
    </reference>
    <reference>
      <citation>Tsuge M, Murakami E, Imamura M, Abe H, Miki D, Hiraga N, Takahashi S, Ochi H, Nelson Hayes C, Ginba H, Matsuyama K, Kawakami H, Chayama K. Serum HBV RNA and HBeAg are useful markers for the safe discontinuation of nucleotide analogue treatments in chronic hepatitis B patients. J Gastroenterol. 2013 Oct;48(10):1188-204. doi: 10.1007/s00535-012-0737-2. Epub 2013 Feb 9.</citation>
      <PMID>23397114</PMID>
    </reference>
    <reference>
      <citation>Serum hepatitis B virus RNA levels as an early predictor of hepatitis B envelope antigen seroconversion during treatment with polymerase inhibitors. Hepatology. 2016 Jan;63(1):349. doi: 10.1002/hep.28349. No abstract available.</citation>
      <PMID>26689731</PMID>
    </reference>
    <reference>
      <citation>Department of Medical Administration, National Health and Health Commission of the People's Republic of China. [Guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition)]. Zhonghua Gan Zang Bing Za Zhi. 2020 Feb 20;28(2):112-128. doi: 10.3760/cma.j.issn.1007-3418.2020.02.004. No abstract available. Chinese.</citation>
      <PMID>32164061</PMID>
    </reference>
    <reference>
      <citation>Chinese Society of Hepatology,Chinese Medical Association. [Chinese guidelines on the management of liver cirrhosis]. Zhonghua Gan Zang Bing Za Zhi. 2019 Nov 20;27(11):846-865. doi: 10.3760/cma.j.issn.1007-3418.2019.11.008. Chinese.</citation>
      <PMID>31941240</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Huashan Hospital</investigator_affiliation>
      <investigator_full_name>Wen-hong Zhang</investigator_full_name>
      <investigator_title>Director of Division ofInfectious Diseases Affiliation: Huashan Hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis B</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Interferons</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965388
  org study id: COMPASS by REASON
  nct id: NCT05965388
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this prospective, exploratory, non-intervention, multi-center, real-world study
        is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes
        under antiviral therapy in patients with chronic hepatitis B.
  
        Participants will take the necessary clinical examination and blood draw during the patient's
        treatment and follow-up, and all the treatment is determined by clinicians.
  This study is a prospective, exploratory, multi-center, real-world study, with Huashan
        Hospital as the leading unit. The study includes patients with chronic hepatitis B who have
        been determined by clinicians to start, or have already taken the first-line treatment {
        including pegylated interferon [IFN] monotherapy, a potent nucleos(t)ide analogue [NA]
        monotherapy, two different potent NAs combination therapy, or NA plus IFN combination
        therapy. The study only collects clinical data and serum samples, without imposing any
        additional intervention measures or affecting any relevant clinical decisions. The clinical
        data is collected from the patient's clinical follow-up examination data, without additional
        visits and auxiliary examinations. Sample collection During the necessary clinical
        examination and blood draw during the patient's treatment and follow-up, one additional serum
        separation tube (3ml) was drawn, without additional invasive examination for the patient. The
        study will follow up with patients for 5 years to explore the relationship between the serum
        HBV pgRNA level and the endpoint event at different time points.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period
  time frame: 5 years
  description: Number of Participants with Diagnosis of hepatocellular carcinoma
  measure: Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period
  time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
  description: Number of Participants with Diagnosis of participants with decompensation cirrhosis
  measure: Number of Participants with Diagnosis of participants with liver transplantation during the observation period
  time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
  description: Number of Participants with Diagnosis of participants with liver transplantation
  measure: Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period
  time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
  description: Number of Participants with Diagnosis of participants with fibrosis regression and progression
  measure: Number of Participants with Diagnosis of participants with serological response during the observation period
  time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
  description: Hepatitis B s Antigen (HBsAg) Loss, seroconversion to HBsAg, Hepatitis B s Antigen (HBeAg) Loss (only patients who are HBeAg positive at baseline), and seroconversion to HBeAg
  arm group label: Chronic hepatitis B patients treated with nucleoside analogues or interferon
  description: Chronic hepatitis B patients treated with nucleoside analogues or interferon
  intervention type: Drug
  intervention name: nucleoside analogues or interferon
  description: ETV、TDF、TAF、TAF、IFN-a-2b
  arm group label: Chronic hepatitis B patients treated with nucleoside analogues or interferon
  Collect the serum samples of CHB patients receiving antiviral therapy during long-term
        follow-up, and detect the concentration of HBV pgRNA in the samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Wenhong Zhang, MD
  phone: 13801844344
  email: zhangwenhong@fudan.edu.cn
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  facility: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  contact backup: 
  country: China
  citation: Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28.
  PMID: 26231459
  citation: Chinese Society of Infectious Diseases, Chinese Medical Association; Chinese Society of Hepatology, Chinese Medical Association. [The guidelines of prevention and treatment for chronic hepatitis B (2019 version)]. Zhonghua Gan Zang Bing Za Zhi. 2019 Dec 20;27(12):938-961. doi: 10.3760/cma.j.issn.1007-3418.2019.12.007. Chinese.
  PMID: 31941257
  citation: Jung MC, Pape GR. Immunology of hepatitis B infection. Lancet Infect Dis. 2002 Jan;2(1):43-50. doi: 10.1016/s1473-3099(01)00172-4.
  PMID: 11892495
  citation: Shin EC, Sung PS, Park SH. Immune responses and immunopathology in acute and chronic viral hepatitis. Nat Rev Immunol. 2016 Aug;16(8):509-23. doi: 10.1038/nri.2016.69. Epub 2016 Jul 4.
  PMID: 27374637
  citation: Nassal M. HBV cccDNA: viral persistence reservoir and key obstacle for a cure of chronic hepatitis B. Gut. 2015 Dec;64(12):1972-84. doi: 10.1136/gutjnl-2015-309809. Epub 2015 Jun 5.
  PMID: 26048673
  citation: Pollicino T, Belloni L, Raffa G, Pediconi N, Squadrito G, Raimondo G, Levrero M. Hepatitis B virus replication is regulated by the acetylation status of hepatitis B virus cccDNA-bound H3 and H4 histones. Gastroenterology. 2006 Mar;130(3):823-37. doi: 10.1053/j.gastro.2006.01.001.
  PMID: 16530522
  citation: Ko C, Chakraborty A, Chou WM, Hasreiter J, Wettengel JM, Stadler D, Bester R, Asen T, Zhang K, Wisskirchen K, McKeating JA, Ryu WS, Protzer U. Hepatitis B virus genome recycling and de novo secondary infection events maintain stable cccDNA levels. J Hepatol. 2018 Dec;69(6):1231-1241. doi: 10.1016/j.jhep.2018.08.012. Epub 2018 Aug 22.
  PMID: 30142426
  citation: Tang LSY, Covert E, Wilson E, Kottilil S. Chronic Hepatitis B Infection: A Review. JAMA. 2018 May 1;319(17):1802-1813. doi: 10.1001/jama.2018.3795. Erratum In: JAMA. 2018 Sep 18;320(11):1202.
  PMID: 29715359
  citation: Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.
  PMID: 29405329
  citation: European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.
  PMID: 28427875
  citation: Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15.
  PMID: 28620797
  citation: Kim GA, Lim YS, An J, Lee D, Shim JH, Kim KM, Lee HC, Chung YH, Lee YS, Suh DJ. HBsAg seroclearance after nucleoside analogue therapy in patients with chronic hepatitis B: clinical outcomes and durability. Gut. 2014 Aug;63(8):1325-32. doi: 10.1136/gutjnl-2013-305517. Epub 2013 Oct 25.
  PMID: 24162593
  citation: Lim TH, Gane E, Moyes C, Borman B, Cunningham C. HBsAg loss in a New Zealand community study with 28-year follow-up: rates, predictors and long-term outcomes. Hepatol Int. 2016 Sep;10(5):829-37. doi: 10.1007/s12072-016-9709-6. Epub 2016 Mar 8.
  PMID: 26957439
  citation: Wang YX, Niklasch M, Liu T, Wang Y, Shi B, Yuan W, Baumert TF, Yuan Z, Tong S, Nassal M, Wen YM. Interferon-inducible MX2 is a host restriction factor of hepatitis B virus replication. J Hepatol. 2020 May;72(5):865-876. doi: 10.1016/j.jhep.2019.12.009. Epub 2019 Dec 18.
  PMID: 31863794
  citation: Tan G, Yi Z, Song H, Xu F, Li F, Aliyari R, Zhang H, Du P, Ding Y, Niu J, Wang X, Su L, Qin FX, Cheng G. Type-I-IFN-Stimulated Gene TRIM5gamma Inhibits HBV Replication by Promoting HBx Degradation. Cell Rep. 2019 Dec 10;29(11):3551-3563.e3. doi: 10.1016/j.celrep.2019.11.041.
  PMID: 31825835
  citation: Sadler AJ, Williams BR. Interferon-inducible antiviral effectors. Nat Rev Immunol. 2008 Jul;8(7):559-68. doi: 10.1038/nri2314.
  PMID: 18575461
  citation: Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.
  PMID: 26453773
  citation: Reijnders JG, Rijckborst V, Sonneveld MJ, Scherbeijn SM, Boucher CA, Hansen BE, Janssen HL. Kinetics of hepatitis B surface antigen differ between treatment with peginterferon and entecavir. J Hepatol. 2011 Mar;54(3):449-54. doi: 10.1016/j.jhep.2010.07.046. Epub 2010 Nov 5.
  PMID: 21112655
  citation: Wursthorn K, Lutgehetmann M, Dandri M, Volz T, Buggisch P, Zollner B, Longerich T, Schirmacher P, Metzler F, Zankel M, Fischer C, Currie G, Brosgart C, Petersen J. Peginterferon alpha-2b plus adefovir induce strong cccDNA decline and HBsAg reduction in patients with chronic hepatitis B. Hepatology. 2006 Sep;44(3):675-84. doi: 10.1002/hep.21282.
  PMID: 16941693
  citation: van Bommel F, van Bommel A, Krauel A, Wat C, Pavlovic V, Yang L, Deichsel D, Berg T, Bohm S. Serum HBV RNA as a Predictor of Peginterferon Alfa-2a Response in Patients With HBeAg-Positive Chronic Hepatitis B. J Infect Dis. 2018 Aug 24;218(7):1066-1074. doi: 10.1093/infdis/jiy270.
  PMID: 29741634
  citation: Huang YW, Takahashi S, Tsuge M, Chen CL, Wang TC, Abe H, Hu JT, Chen DS, Yang SS, Chayama K, Kao JH. On-treatment low serum HBV RNA level predicts initial virological response in chronic hepatitis B patients receiving nucleoside analogue therapy. Antivir Ther. 2015;20(4):369-75. doi: 10.3851/IMP2777. Epub 2014 Apr 16.
  PMID: 24739420
  citation: Jansen L, Kootstra NA, van Dort KA, Takkenberg RB, Reesink HW, Zaaijer HL. Hepatitis B Virus Pregenomic RNA Is Present in Virions in Plasma and Is Associated With a Response to Pegylated Interferon Alfa-2a and Nucleos(t)ide Analogues. J Infect Dis. 2016 Jan 15;213(2):224-32. doi: 10.1093/infdis/jiv397. Epub 2015 Jul 27.
  PMID: 26216905
  citation: Tsuge M, Murakami E, Imamura M, Abe H, Miki D, Hiraga N, Takahashi S, Ochi H, Nelson Hayes C, Ginba H, Matsuyama K, Kawakami H, Chayama K. Serum HBV RNA and HBeAg are useful markers for the safe discontinuation of nucleotide analogue treatments in chronic hepatitis B patients. J Gastroenterol. 2013 Oct;48(10):1188-204. doi: 10.1007/s00535-012-0737-2. Epub 2013 Feb 9.
  PMID: 23397114
  citation: Serum hepatitis B virus RNA levels as an early predictor of hepatitis B envelope antigen seroconversion during treatment with polymerase inhibitors. Hepatology. 2016 Jan;63(1):349. doi: 10.1002/hep.28349. No abstract available.
  PMID: 26689731
  citation: Department of Medical Administration, National Health and Health Commission of the People's Republic of China. [Guidelines for diagnosis and treatment of primary liver cancer in China (2019 edition)]. Zhonghua Gan Zang Bing Za Zhi. 2020 Feb 20;28(2):112-128. doi: 10.3760/cma.j.issn.1007-3418.2020.02.004. No abstract available. Chinese.
  PMID: 32164061
  citation: Chinese Society of Hepatology,Chinese Medical Association. [Chinese guidelines on the management of liver cirrhosis]. Zhonghua Gan Zang Bing Za Zhi. 2019 Nov 20;27(11):846-865. doi: 10.3760/cma.j.issn.1007-3418.2019.11.008. Chinese.
  PMID: 31941240
  responsible party type: Sponsor-Investigator
  investigator affiliation: Huashan Hospital
  investigator full name: Wen-hong Zhang
  investigator title: Director of Division ofInfectious Diseases Affiliation: Huashan Hospital
  mesh term: Hepatitis B
  mesh term: Interferons
  sharing ipd: Undecided