<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/NCT02263755</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0582</org_study_id>
    <nct_id>NCT02263755</nct_id>
  </id_info>
  <brief_title>Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to the World Health Organization about 1,400,000 deaths reported annually, are&#xD;
      related to chronic liver disease. Chronic liver disease is very prevalent in South Korea,&#xD;
      placing a large economic burden nationwide. Subsequently, an effective and systematized&#xD;
      approach to managing chronic hepatitis is imperative in Korea.&#xD;
&#xD;
      The natural history of chronic liver disease differs greatly according to race and ethnicity.&#xD;
      However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients.&#xD;
      Therefore, the investigators plan to establish a retrospective and prospective multicenter&#xD;
      cohort for chronic hepatitis B based on Korean patients that may be utilized for various&#xD;
      future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the&#xD;
      establishment and distribution of clinical guidelines for Korean patients with chronic&#xD;
      hepatitis B, as part of a nationwide project supported by the Centers for Disease Control&#xD;
      (CDC), Korea.&#xD;
&#xD;
      The investigators plan to collect 500 cases as have been advised by the CDC during the study&#xD;
      period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past&#xD;
      5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver&#xD;
      fibroscan and liver biopsy from these 4 institutions. The investigators plan to register&#xD;
      available cases retrospectively from those who are available to agree to give written&#xD;
      informed consent to participate in this study, and to register the remaining numbers of cases&#xD;
      prospectively, according to the inclusion and exclusion criteria.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2014</start_date>
  <completion_date type="Actual">June 25, 2015</completion_date>
  <primary_completion_date type="Actual">June 25, 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients</measure>
    <time_frame>time of registration of patient to cohort completment</time_frame>
    <description>This study aims for the establishment of chronic hepatitis B cohort and has no other primary end point other than the registration of the patient. (For Time-to-Event outcome measures, the development of events including HCC, ascitic decompensation, variceal bleeding, hepatic encephalopathy, transplantation, and death will be followed up to 10 years after enrollment. Time to the development of each kind of event will be calculated from the date of enrollment and the respective date of event development.)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">476</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>chronic hepatitis B subjects</arm_group_label>
    <description>Subjects who have been diagnosed with chronic hepatitis B.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        outpatient clinic in tertiary hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject aged 20 years or older&#xD;
&#xD;
          2. Subject who has been diagnosed with chronic hepatitis B (HBs Ag (+) for minimum of 6&#xD;
             months_&#xD;
&#xD;
          3. Subject who is currently under clinical follow up at the registered institution&#xD;
&#xD;
          4. Subject who has undergone or who can undergo liver fibroscan at the time of&#xD;
             registration&#xD;
&#xD;
          5. Subject who has given informed consent to the enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject with decompensated liver cirrhosis or hepatocellular carcinoma at the time of&#xD;
             initial liver fibroscan&#xD;
&#xD;
          2. Subject who had previously undergone antiviral therapy for chronic hepatitis B&#xD;
&#xD;
          3. Subject who are concomittantly infected with HCV, HDV or HIV&#xD;
&#xD;
          4. Subject with chronic alcoholism defined as equal to or greater than 40g of alcohol for&#xD;
             duration of 5 years or longer&#xD;
&#xD;
          5. Subject who has been diagnosed with right sided heart failure&#xD;
&#xD;
          6. Subjects whose liver fibroscan result is not valid&#xD;
&#xD;
          7. Subject who is considered ineligible to the enrollment to clinical study by the&#xD;
             researcher&#xD;
&#xD;
          8. Subjects who is pregnant at the time of registration&#xD;
&#xD;
          9. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwang Hyub Han, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yonsei University</affiliation>
  </overall_official>
  <reference>
    <citation>Jung KS, Kim SU, Ahn SH, Park YN, Kim DY, Park JY, Chon CY, Choi EH, Han KH. Risk assessment of hepatitis B virus-related hepatocellular carcinoma development using liver stiffness measurement (FibroScan). Hepatology. 2011 Mar;53(3):885-94. doi: 10.1002/hep.24121. Epub 2011 Feb 11.</citation>
    <PMID>21319193</PMID>
  </reference>
  <reference>
    <citation>Kim SU, Ahn SH, Park JY, Kang W, Kim DY, Park YN, Chon CY, Han KH. Liver stiffness measurement in combination with noninvasive markers for the improved diagnosis of B-viral liver cirrhosis. J Clin Gastroenterol. 2009 Mar;43(3):267-71. doi: 10.1097/MCG.0b013e31816f212e.</citation>
    <PMID>18987556</PMID>
  </reference>
  <reference>
    <citation>Kim SU, Seo YS, Cheong JY, Kim MY, Kim JK, Um SH, Cho SW, Paik SK, Lee KS, Han KH, Ahn SH. Factors that affect the diagnostic accuracy of liver fibrosis measurement by Fibroscan in patients with chronic hepatitis B. Aliment Pharmacol Ther. 2010 Aug;32(3):498-505. doi: 10.1111/j.1365-2036.2010.04353.x. Epub 2010 May 11.</citation>
    <PMID>20491742</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CHB, cohort, fibroscan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02263755
org study id: 4-2014-0582
nct id: NCT02263755
lead sponsor: 
has dmc: No
According to the World Health Organization about 1,400,000 deaths reported annually, are
      related to chronic liver disease. Chronic liver disease is very prevalent in South Korea,
      placing a large economic burden nationwide. Subsequently, an effective and systematized
      approach to managing chronic hepatitis is imperative in Korea.

      The natural history of chronic liver disease differs greatly according to race and ethnicity.
      However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients.
      Therefore, the investigators plan to establish a retrospective and prospective multicenter
      cohort for chronic hepatitis B based on Korean patients that may be utilized for various
      future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the
      establishment and distribution of clinical guidelines for Korean patients with chronic
      hepatitis B, as part of a nationwide project supported by the Centers for Disease Control
      (CDC), Korea.

      The investigators plan to collect 500 cases as have been advised by the CDC during the study
      period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past
      5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver
      fibroscan and liver biopsy from these 4 institutions. The investigators plan to register
      available cases retrospectively from those who are available to agree to give written
      informed consent to participate in this study, and to register the remaining numbers of cases
      prospectively, according to the inclusion and exclusion criteria.
observational model: Cohort
time perspective: Other
measure: retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients
time frame: time of registration of patient to cohort completment
description: This study aims for the establishment of chronic hepatitis B cohort and has no other primary end point other than the registration of the patient. (For Time-to-Event outcome measures, the development of events including HCC, ascitic decompensation, variceal bleeding, hepatic encephalopathy, transplantation, and death will be followed up to 10 years after enrollment. Time to the development of each kind of event will be calculated from the date of enrollment and the respective date of event development.)
arm group label: chronic hepatitis B subjects
description: Subjects who have been diagnosed with chronic hepatitis B.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kwang Hyub Han, MD,PhD
role: Principal Investigator
affiliation: Yonsei University
citation: Jung KS, Kim SU, Ahn SH, Park YN, Kim DY, Park JY, Chon CY, Choi EH, Han KH. Risk assessment of hepatitis B virus-related hepatocellular carcinoma development using liver stiffness measurement (FibroScan). Hepatology. 2011 Mar;53(3):885-94. doi: 10.1002/hep.24121. Epub 2011 Feb 11.
PMID: 21319193
citation: Kim SU, Ahn SH, Park JY, Kang W, Kim DY, Park YN, Chon CY, Han KH. Liver stiffness measurement in combination with noninvasive markers for the improved diagnosis of B-viral liver cirrhosis. J Clin Gastroenterol. 2009 Mar;43(3):267-71. doi: 10.1097/MCG.0b013e31816f212e.
PMID: 18987556
citation: Kim SU, Seo YS, Cheong JY, Kim MY, Kim JK, Um SH, Cho SW, Paik SK, Lee KS, Han KH, Ahn SH. Factors that affect the diagnostic accuracy of liver fibrosis measurement by Fibroscan in patients with chronic hepatitis B. Aliment Pharmacol Ther. 2010 Aug;32(3):498-505. doi: 10.1111/j.1365-2036.2010.04353.x. Epub 2010 May 11.
PMID: 20491742
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic