<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/NCT03801798</url>
  </required_header>
  <id_info>
    <org_study_id>GC1102B_P2a</org_study_id>
    <nct_id>NCT03801798</nct_id>
  </id_info>
  <brief_title>A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients</brief_title>
  <official_title>A Double-blind, Randomized, Placebo Controlled, Parallel-group, Phase 2a Study to Evaluate the Efficacy and Safety of GC1102 in Combination With Nucleos(t)Ide Analogues (NAs) in Patients With Chronic Hepatitis B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Green Cross Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GC Biopharma Corp</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of&#xD;
      Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with ≥ 1log10 reduction in HBsAg titer</measure>
    <time_frame>from baseline at Week 48 after the first dose of investigational product</time_frame>
    <description>HBsAg titer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer</measure>
    <time_frame>from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product</time_frame>
    <description>HBsAg titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with ≥ 1log10 reduction in HBsAg titer</measure>
    <time_frame>from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product</time_frame>
    <description>HBsAg titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HBsAg titer</measure>
    <time_frame>from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product</time_frame>
    <description>HBsAg titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT response rates</measure>
    <time_frame>from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product</time_frame>
    <description>Proportions of subjects with ALT ≤ 1.0 X ULN at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with ALT &gt;1.0 X ULN at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBeAg seroconversion rates</measure>
    <time_frame>from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product</time_frame>
    <description>Proportions of subjects with negative (-) HBeAg result at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with positive (+) HBeAg result at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of HBsAg loss</measure>
    <time_frame>from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product</time_frame>
    <description>Proportions of subjects with negative (-; below the limit of detection of 0.5 IU/mL) HBsAg result at Weeks 24, 28, 36 and 48 after the first dose of investigational product</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point</measure>
    <time_frame>from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product</time_frame>
    <description>Proportion of subjects with negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>NAs antivirals + GC1102 180,000 IU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.&#xD;
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL&#xD;
V2 to V17 : IV bolus injection twice a week&#xD;
V18 to V33 : IV bolus injection once a week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAs antivirals + GC1102 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.&#xD;
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL&#xD;
V2 to V17: IV bolus injection twice a week&#xD;
V18 to V33: IV bolus injection once a week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GC1102</intervention_name>
    <description>NAs antivirals+GC1102 180,000 IU</description>
    <arm_group_label>NAs antivirals + GC1102 180,000 IU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GC1102 Placebo</intervention_name>
    <description>NAs antivirals+GC1102 Placebo</description>
    <arm_group_label>NAs antivirals + GC1102 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had this study information explained to them and understood it,&#xD;
             voluntarily decided participation, and provided written consent&#xD;
&#xD;
          -  Patients who Aged ≥19 and ≤ 65 years at the time of signing the consent form&#xD;
&#xD;
          -  Patients with chronic hepatitis B who have been taking Nucleos(t)ide analogue&#xD;
             antivirals 24 weeks before screening&#xD;
&#xD;
          -  Patients whose HBsAg and HBV DNA in blood; 10 IU/mL ≤ HBsAg titer ≤ 1,000 IU/mL and&#xD;
             negative(-; below the limit of detection of 10 IU/mL) HBV DNA in the screening test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have Hepatic diseases (e.g., autoimmune hepatitis) from causes other than&#xD;
             hepatitis B&#xD;
&#xD;
          -  Patients who have history of liver transplantation, or liver transplantation schedule&#xD;
             during the study&#xD;
&#xD;
          -  Patients who co-infected with HAV, HCV, HDV and HIV&#xD;
&#xD;
          -  Patient with Vasculitis&#xD;
&#xD;
          -  Patients who had a loss of blood or donated blood of ≥ 400mL within 8 weeks before the&#xD;
             screening&#xD;
&#xD;
          -  patient who have active infection(other than chronic hepatitis B infection) requiring&#xD;
             continual treatment with antibiotics or antivirals (except for clinically&#xD;
             insignificant temporary infection such as cold)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang Hoon Ahn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GC1102</keyword>
  <keyword>GC1102B</keyword>
  <keyword>Chronic Hepatitis B virus</keyword>
  <keyword>CHB</keyword>
  <keyword>NAs</keyword>
  <keyword>NUC</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/NCT03801798
org study id: GC1102B_P2a
nct id: NCT03801798
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of
      Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
time frame: from baseline at Week 48 after the first dose of investigational product
description: HBsAg titer
measure: Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer
time frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
description: HBsAg titer
measure: Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
time frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
description: HBsAg titer
measure: Change in HBsAg titer
time frame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
description: HBsAg titer
measure: ALT response rates
time frame: from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
description: Proportions of subjects with ALT ≤ 1.0 X ULN at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with ALT >1.0 X ULN at baseline
measure: HBeAg seroconversion rates
time frame: from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product
description: Proportions of subjects with negative (-) HBeAg result at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with positive (+) HBeAg result at baseline
measure: Rate of HBsAg loss
time frame: from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product
description: Proportions of subjects with negative (-; below the limit of detection of 0.5 IU/mL) HBsAg result at Weeks 24, 28, 36 and 48 after the first dose of investigational product
measure: Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
time frame: from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
description: Proportion of subjects with negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
arm group label: NAs antivirals + GC1102 180,000 IU
arm group type: Experimental
description: All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL
V2 to V17 : IV bolus injection twice a week
V18 to V33 : IV bolus injection once a week
arm group label: NAs antivirals + GC1102 Placebo
arm group type: Placebo Comparator
description: All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study.
Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL
V2 to V17: IV bolus injection twice a week
V18 to V33: IV bolus injection once a week
intervention type: Drug
intervention name: GC1102
description: NAs antivirals+GC1102 180,000 IU
arm group label: NAs antivirals + GC1102 180,000 IU
intervention type: Other
intervention name: GC1102 Placebo
description: NAs antivirals+GC1102 Placebo
arm group label: NAs antivirals + GC1102 Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sang Hoon Ahn, MD
role: Principal Investigator
affiliation: Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic