<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/NCT02258581</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-330-1508</org_study_id>
    <secondary_id>2015-001050-16</secondary_id>
    <nct_id>NCT02258581</nct_id>
  </id_info>
  <brief_title>Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection</brief_title>
  <official_title>A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the&#xD;
      HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only&#xD;
      individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">December 9, 2014</start_date>
  <completion_date type="Actual">August 14, 2017</completion_date>
  <primary_completion_date type="Actual">August 14, 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>Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>This endpoint will be measured for participants who are HBsAg positive at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who remain HBsAg negative at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>This endpoint will be measured for participants who are HBsAg negative at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144</measure>
    <time_frame>Week 144</time_frame>
    <description>This endpoint will be measured for participants who are HBsAg positive at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who achieve HBsAg loss at Weeks 48 and 144</measure>
    <time_frame>Weeks 48, 144</time_frame>
    <description>This endpoint will be measured for participants who are HBsAg positive at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who remain HBsAg negative at Week 144</measure>
    <time_frame>Week 144</time_frame>
    <description>This endpoint will be measured for participants who are HBsAg negative at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>This endpoint will be measured for participants who are HBeAg positive at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of participants with HBeAg loss and seroconversion at Week 144</measure>
    <time_frame>Week 144</time_frame>
    <description>This endpoint will be measured for participants who are HBeAg positive at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144</measure>
    <time_frame>Week 144</time_frame>
    <description>This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with HBV DNA &lt; the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144</measure>
    <time_frame>Weeks 48, 96 and 144</time_frame>
    <description>This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in HBV DNA at Weeks 48, 96, and 144</measure>
    <time_frame>Baseline; Week 48; Week 96; Week 144</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">241</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GS-4774</intervention_name>
    <description>Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GS-9620</intervention_name>
    <description>Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir disoproxil fumarate (TDF)</intervention_name>
    <description>Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.</description>
    <other_name>Viread®</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more&#xD;
             than 120 days prior to Baseline (Day 1), except for participants from previous&#xD;
             Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their&#xD;
             last visit in that protocol.&#xD;
&#xD;
          -  Must have the ability to understand and sign a written informed consent form, which&#xD;
             must be obtained prior to initiation of study procedures&#xD;
&#xD;
          -  Must be willing and able to comply with the visit schedule and study requirements&#xD;
&#xD;
          -  Must have documented HBV DNA &lt; 2,000 IU/mL at time of screening visit, which shall&#xD;
             occur no later than 1 year post last study visit in GS-US-174-0149&#xD;
&#xD;
          -  Must have documented hepatitis B surface antigen (HBsAg) negative status anytime&#xD;
             during participation in GS-US-174-0149 regardless of ongoing HBV treatment&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Patient participating or planning to participate in another clinical study with an&#xD;
             investigational agent&#xD;
&#xD;
          -  History of clinically-significant illness or any other major medical disorder that may&#xD;
             interfere with follow-up, assessments or compliance with the protocol&#xD;
&#xD;
          -  Believed by the Study Investigator to be inappropriate for study participation for any&#xD;
             reason not otherwise listed&#xD;
&#xD;
          -  Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm)&#xD;
             or for TDF retreatment, and have taken any HBV antiviral therapy since completion of&#xD;
             GS-US-174-0149&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#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>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silicon Valley Research Institute</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Queen's Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Associates, PA</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Procare, PLL</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiaoli Ma, PC</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours St. Mary's Hospital of Richmond</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon and Leslie Diamond Health Care Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liver and Intestinal Research Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnepeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Lai Chi Kok</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nirmal Hospital Private Limited</name>
      <address>
        <city>Surat</city>
        <state>Gurarat</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midas Multispecialty Hospital Private Limited</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Hepatology, School of Digestive &amp; Liver Diseases</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Foggia</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Pisana</name>
      <address>
        <city>Caianello</city>
        <state>Pisa</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Hong Kong</country>
    <country>India</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 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>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Vesatolimod</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/NCT02258581
org study id: GS-US-330-1508
secondary id: 2015-001050-16
nct id: NCT02258581
lead sponsor: 
has dmc: No
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the
      HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only
      individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).
observational model: Cohort
time perspective: Prospective
measure: Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48
time frame: Week 48
description: This endpoint will be measured for participants who are HBsAg positive at baseline.
measure: Proportion of participants who remain HBsAg negative at Week 48
time frame: Week 48
description: This endpoint will be measured for participants who are HBsAg negative at baseline.
measure: Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144
time frame: Week 144
description: This endpoint will be measured for participants who are HBsAg positive at baseline.
measure: Proportion of participants who achieve HBsAg loss at Weeks 48 and 144
time frame: Weeks 48, 144
description: This endpoint will be measured for participants who are HBsAg positive at baseline.
measure: Proportion of participants who remain HBsAg negative at Week 144
time frame: Week 144
description: This endpoint will be measured for participants who are HBsAg negative at baseline.
measure: Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48
time frame: Week 48
description: This endpoint will be measured for participants who are HBeAg positive at baseline.
measure: Proportions of participants with HBeAg loss and seroconversion at Week 144
time frame: Week 144
description: This endpoint will be measured for participants who are HBeAg positive at baseline.
measure: Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48
time frame: Week 48
description: This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
measure: Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144
time frame: Week 144
description: This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
measure: Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144
time frame: Weeks 48, 96 and 144
description: This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.
measure: Change from Baseline in HBV DNA at Weeks 48, 96, and 144
time frame: Baseline; Week 48; Week 96; Week 144
intervention type: Drug
intervention name: GS-4774
description: Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.
intervention type: Drug
intervention name: GS-9620
description: Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
intervention type: Drug
intervention name: Tenofovir disoproxil fumarate (TDF)
description: Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
other name: Viread®
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Australia
country: Canada
country: Hong Kong
country: India
country: Italy
country: Korea, Republic of
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Tenofovir
mesh term: Vesatolimod