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/NCT05977283</url>
    </required_header>
    <id_info>
      <org_study_id>NFEC-2022-260</org_study_id>
      <nct_id>NCT05977283</nct_id>
    </id_info>
    <brief_title>HBsAg Declined Patients Follow-up Study</brief_title>
    <official_title>An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanfang Hospital, Southern Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to prospectively follow chronic hepatitis B patients&#xD;
        who had HBsAg decline in the past 6 months prior to screening. The main question it aims to&#xD;
        answer are:&#xD;
  &#xD;
        - Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had&#xD;
        HBsAg decline in past 6 months due to any reason (with or without new molecular entities&#xD;
        therapy).&#xD;
  &#xD;
        Participants will be followed up for 36 months after enrollment and may be extended upon&#xD;
        expiration according to study objectives.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a retrospective and prospective follow-up study for participants who had HBsAg&#xD;
        decline in past 6 months due to any reason (with or without new molecular entities therapy).&#xD;
        The follow-up period will be 3 years (36 months after enrollment) and may be extended upon&#xD;
        expiration according to study objectives. Patients are treated or untreated based on current&#xD;
        clinical practice guidelines, and every medical decision and course of treatment will reflect&#xD;
        exclusively the decision of the treating physician in a routine clinical situation. The&#xD;
        conduct of this non-interventional follow-up study and its documentation procedures will not&#xD;
        affect the routine treatment of the subjects. It is only requested that any medical&#xD;
        decisions, procedures and data during this study be documented in the electronic case&#xD;
        report/record form (eCRF) according to the study protocol as available from routine medical&#xD;
        care. Diagnostic testing and monitoring procedures are exclusively based on the decision of&#xD;
        the treating physician.&#xD;
  &#xD;
        In general, patients with hepatitis B should be monitored at least twice a year (every 6&#xD;
        months), every 12 weeks during NUC therapy and every 2 to 4 weeks during interferon-α therapy&#xD;
        in accordance with clinical needs (Table 3-1 and Table 3-2). For patients had HBsAg decline&#xD;
        in past 6 months due to new molecular entities therapy, The baseline of this follow-up study&#xD;
        is the time when NME discontinued (within 28 days of the last does of NME or within 2&#xD;
        half-life period of the NME). For patients had HBsAg decline in past 6 months without new&#xD;
        molecular entities therapy, the baseline should be the time of enrolling in the study. The&#xD;
        time of enrolling in this study may be posterior or equal to baseline, which is not&#xD;
        necessarily the baseline of this study. The visit window period is ±28 days for patients with&#xD;
        NUC therapy and ±7 days for patients with interferon-α therapy. Follow-up study visit data&#xD;
        can be collected retrospectively if it has been performed before entry of this study.&#xD;
  &#xD;
        Medical decisions, procedures and data before this follow-up study will also be documented if&#xD;
        available. Participants will be asked to store a certain amount of blood samples in site&#xD;
        during study visit for future HBV markers, host immunity or other related tests. The retained&#xD;
        remaining samples from previous tests before this follow-up study may also be used for HBV&#xD;
        related exploratory research after patient informed consent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 2028</completion_date>
    <primary_completion_date type="Anticipated">June 2027</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>Proportion of participants with HBsAg loss (&lt;0.05 IU/ml) at 12 months</measure>
      <time_frame>at week 48</time_frame>
      <description>Describe treatment pattern and its impact on HBsAg loss of the included patients (with or without new molecular entities therapy) by the proportion of participants with HBsAg loss at week 48.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with HBsAg loss or HBsAg seroconversion.</measure>
      <time_frame>at week 48, 96 and 144</time_frame>
      <description>HBsAg loss / seroconversion at each study visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in quantitative HBsAg levels over time</measure>
      <time_frame>at week 48, 96 and 144</time_frame>
      <description>including but not limited to actual values and changes from Baseline (Pre-treatment, 6 month prior to screening, and the beginning of follow-up study) at week 48, 96 and 144 in HBsAg, HBV DNA, HBeAg, HBcrAg, HBV RNA level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in quantitative anti-HBs levels over time</measure>
      <time_frame>at week 48, 96 and 144</time_frame>
      <description>Describe the development of anti-HBs over time for hepatitis B patients with HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality, at each study visit</measure>
      <time_frame>at week 48, 96 and 144</time_frame>
      <description>The incidence of de novo liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of Health-related quality-of-life (HRQoL) over time</measure>
      <time_frame>at week 48, 96 and 144</time_frame>
      <description>evaluated the risk factors on the progression of CHB, by the available data</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Hepatitis B</condition>
    <condition>Hepatitis B, Chronic</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Participants will be asked to store a certain amount of blood samples in site during study&#xD;
        visit for future HBV markers, host immunity or other related tests. The retained remaining&#xD;
        samples from previous tests before this follow-up study may also be used for HBV related&#xD;
        exploratory research after patient informed consent.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 6 months prior to screening&#xD;
          due to any reason (with or without new molecular entities therapy). Among the enrolled&#xD;
          subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 6 months prior to&#xD;
               screening due to any reason (with or without new molecular entities therapy). Among&#xD;
               the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3&#xD;
               log10 IU/mL.&#xD;
  &#xD;
            -  Able and willing to provide written informed consent and to comply with the study&#xD;
               protocol according to International Council for Harmonization (ICH) and local&#xD;
               regulations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any condition which, in the opinion of the investigator, contraindicates their&#xD;
               participant in this study.&#xD;
  &#xD;
            -  Participants who are currently participating in interventional clinical study&#xD;
               exploring HBV treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>jinlin hou, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xieer Liang, M.D.</last_name>
      <phone>+862062787432</phone>
      <email>freeliang@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhihong Liu, M.D.</last_name>
      <phone>+862062787432</phone>
      <email>liucas@smu.edu.cn</email>
    </overall_contact_backup>
    <reference>
      <citation>BLUMBERG BS, ALTER HJ, VISNICH S. A &quot;NEW&quot; ANTIGEN IN LEUKEMIA SERA. JAMA. 1965 Feb 15;191:541-6. doi: 10.1001/jama.1965.03080070025007. No abstract available.</citation>
      <PMID>14239025</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>Brunetto MR. A new role for an old marker, HBsAg. J Hepatol. 2010 Apr;52(4):475-7. doi: 10.1016/j.jhep.2009.12.020. Epub 2010 Jan 30. No abstract available.</citation>
      <PMID>20185190</PMID>
    </reference>
    <reference>
      <citation>Chan HL, Thompson A, Martinot-Peignoux M, Piratvisuth T, Cornberg M, Brunetto MR, Tillmann HL, Kao JH, Jia JD, Wedemeyer H, Locarnini S, Janssen HL, Marcellin P. Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report. J Hepatol. 2011 Nov;55(5):1121-31. doi: 10.1016/j.jhep.2011.06.006. Epub 2011 Jun 28.</citation>
      <PMID>21718667</PMID>
    </reference>
    <reference>
      <citation>- Lau G K K, Marcellin P, Brunetto M, et al. 917 on-treatment monitoring of HBsAg levels to predict response to peginterferon alfa-2a in patients with HBeAg-positive chronic hepatitis B[J]. Journal of Hepatology, 2009, 50, Supplement 1(0): S333</citation>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>November 29, 2022</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>chronic hepatitis b</keyword>
    <keyword>HBsAg</keyword>
    <keyword>functional cure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis A</mesh_term>
      <mesh_term>Hepatitis B</mesh_term>
      <mesh_term>Hepatitis B, Chronic</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
    </condition_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/NCT05977283
  org study id: NFEC-2022-260
  nct id: NCT05977283
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to prospectively follow chronic hepatitis B patients
        who had HBsAg decline in the past 6 months prior to screening. The main question it aims to
        answer are:
  
        - Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had
        HBsAg decline in past 6 months due to any reason (with or without new molecular entities
        therapy).
  
        Participants will be followed up for 36 months after enrollment and may be extended upon
        expiration according to study objectives.
  This study is a retrospective and prospective follow-up study for participants who had HBsAg
        decline in past 6 months due to any reason (with or without new molecular entities therapy).
        The follow-up period will be 3 years (36 months after enrollment) and may be extended upon
        expiration according to study objectives. Patients are treated or untreated based on current
        clinical practice guidelines, and every medical decision and course of treatment will reflect
        exclusively the decision of the treating physician in a routine clinical situation. The
        conduct of this non-interventional follow-up study and its documentation procedures will not
        affect the routine treatment of the subjects. It is only requested that any medical
        decisions, procedures and data during this study be documented in the electronic case
        report/record form (eCRF) according to the study protocol as available from routine medical
        care. Diagnostic testing and monitoring procedures are exclusively based on the decision of
        the treating physician.
  
        In general, patients with hepatitis B should be monitored at least twice a year (every 6
        months), every 12 weeks during NUC therapy and every 2 to 4 weeks during interferon-α therapy
        in accordance with clinical needs (Table 3-1 and Table 3-2). For patients had HBsAg decline
        in past 6 months due to new molecular entities therapy, The baseline of this follow-up study
        is the time when NME discontinued (within 28 days of the last does of NME or within 2
        half-life period of the NME). For patients had HBsAg decline in past 6 months without new
        molecular entities therapy, the baseline should be the time of enrolling in the study. The
        time of enrolling in this study may be posterior or equal to baseline, which is not
        necessarily the baseline of this study. The visit window period is ±28 days for patients with
        NUC therapy and ±7 days for patients with interferon-α therapy. Follow-up study visit data
        can be collected retrospectively if it has been performed before entry of this study.
  
        Medical decisions, procedures and data before this follow-up study will also be documented if
        available. Participants will be asked to store a certain amount of blood samples in site
        during study visit for future HBV markers, host immunity or other related tests. The retained
        remaining samples from previous tests before this follow-up study may also be used for HBV
        related exploratory research after patient informed consent.
  observational model: Cohort
  time perspective: Prospective
  measure: Proportion of participants with HBsAg loss (<0.05 IU/ml) at 12 months
  time frame: at week 48
  description: Describe treatment pattern and its impact on HBsAg loss of the included patients (with or without new molecular entities therapy) by the proportion of participants with HBsAg loss at week 48.
  measure: Proportion of participants with HBsAg loss or HBsAg seroconversion.
  time frame: at week 48, 96 and 144
  description: HBsAg loss / seroconversion at each study visit
  measure: Change from baseline in quantitative HBsAg levels over time
  time frame: at week 48, 96 and 144
  description: including but not limited to actual values and changes from Baseline (Pre-treatment, 6 month prior to screening, and the beginning of follow-up study) at week 48, 96 and 144 in HBsAg, HBV DNA, HBeAg, HBcrAg, HBV RNA level
  measure: Change from baseline in quantitative anti-HBs levels over time
  time frame: at week 48, 96 and 144
  description: Describe the development of anti-HBs over time for hepatitis B patients with HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy)
  measure: Incidence of liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality, at each study visit
  time frame: at week 48, 96 and 144
  description: The incidence of de novo liver cirrhosis, hepatocellular carcinoma, other HBV complications and mortality
  measure: The change of Health-related quality-of-life (HRQoL) over time
  time frame: at week 48, 96 and 144
  description: evaluated the risk factors on the progression of CHB, by the available data
  Participants will be asked to store a certain amount of blood samples in site during study
        visit for future HBV markers, host immunity or other related tests. The retained remaining
        samples from previous tests before this follow-up study may also be used for HBV related
        exploratory research after patient informed consent.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: jinlin hou, Master
  role: Principal Investigator
  affiliation: Nanfang Hospital, Southern Medical University
  last name: Xieer Liang, M.D.
  phone: +862062787432
  email: freeliang@163.com
  last name: Zhihong Liu, M.D.
  phone: +862062787432
  email: liucas@smu.edu.cn
  citation: BLUMBERG BS, ALTER HJ, VISNICH S. A "NEW" ANTIGEN IN LEUKEMIA SERA. JAMA. 1965 Feb 15;191:541-6. doi: 10.1001/jama.1965.03080070025007. No abstract available.
  PMID: 14239025
  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: Brunetto MR. A new role for an old marker, HBsAg. J Hepatol. 2010 Apr;52(4):475-7. doi: 10.1016/j.jhep.2009.12.020. Epub 2010 Jan 30. No abstract available.
  PMID: 20185190
  citation: Chan HL, Thompson A, Martinot-Peignoux M, Piratvisuth T, Cornberg M, Brunetto MR, Tillmann HL, Kao JH, Jia JD, Wedemeyer H, Locarnini S, Janssen HL, Marcellin P. Hepatitis B surface antigen quantification: why and how to use it in 2011 - a core group report. J Hepatol. 2011 Nov;55(5):1121-31. doi: 10.1016/j.jhep.2011.06.006. Epub 2011 Jun 28.
  PMID: 21718667
  citation: - Lau G K K, Marcellin P, Brunetto M, et al. 917 on-treatment monitoring of HBsAg levels to predict response to peginterferon alfa-2a in patients with HBeAg-positive chronic hepatitis B[J]. Journal of Hepatology, 2009, 50, Supplement 1(0): S333
  responsible party type: Sponsor
  mesh term: Hepatitis A
  mesh term: Hepatitis B
  mesh term: Hepatitis B, Chronic
  mesh term: Hepatitis
  sharing ipd: Undecided