<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/NCT04426968</url>
  </required_header>
  <id_info>
    <org_study_id>L47-HB-II-02</org_study_id>
    <nct_id>NCT04426968</nct_id>
  </id_info>
  <brief_title>A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B</brief_title>
  <official_title>A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined With Pegylated Interferon in Subjects With Chronic Hepatitis B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai HEP Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai HEP Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect&#xD;
      Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects&#xD;
      with Chronic Hepatitis B&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled,&#xD;
      multicenter, dose-effect relationship, phase II clinical trial. The study is designed to&#xD;
      assess efficacy and safety of 3 Doses of hepalatide in Combination with Pegylated Interferon&#xD;
      Compared to Pegylated Interferon Alone in patients with Chronic Hepatitis B .Subjects will be&#xD;
      randomly assigned to the 2.1mg, 4.2mg, and 6.3mg dose groups , 32 subjects in each group .&#xD;
      The subjects in each dose group will be randomly and double-blindly administered the&#xD;
      corresponding dose of trial drug or placebo in a ratio of 3:1. The subjects in each dose&#xD;
      group who received placebo treatment combine as the placebo group. All subjects will receive&#xD;
      Pegylated Interferon treatment for 28 weeks as the basic treatment,trial drug or placebo&#xD;
      treatment for 24 weeks continuously , followed by a safety follow-up for 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 18, 2021</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>initial virological response</measure>
    <time_frame>24weeks</time_frame>
    <description>HBV DNA&lt;20 IU/ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HBV DNA down from baseline</measure>
    <time_frame>24weeks</time_frame>
    <description>HBV DNA down from baseline log10</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Virological suppression</measure>
    <time_frame>24weeks</time_frame>
    <description>HBV DNA &lt;2,000 IU/ml</description>
  </other_outcome>
  <other_outcome>
    <measure>No response</measure>
    <time_frame>24weeks</time_frame>
    <description>HBsAg &gt;20,000 IU/ml and HBV DNA lower than baseline &lt;2log10 IU/ml</description>
  </other_outcome>
  <other_outcome>
    <measure>Partial virological response</measure>
    <time_frame>24weeks</time_frame>
    <description>HBV DNA &gt;20 IU/ml and ≥2log10 IU/ml lower than baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>HBsAg is down from baseline</measure>
    <time_frame>24weeks</time_frame>
    <description>HBsAg is down from baseline log10</description>
  </other_outcome>
  <other_outcome>
    <measure>HBeAg turned negative</measure>
    <time_frame>24weeks</time_frame>
    <description>HBeAg &lt;0.05 index</description>
  </other_outcome>
  <other_outcome>
    <measure>HBeAg is down from baseline</measure>
    <time_frame>24weeks</time_frame>
    <description>HBeAg is down from baseline log10</description>
  </other_outcome>
  <other_outcome>
    <measure>ALT recurrence</measure>
    <time_frame>24weeks</time_frame>
    <description>ALT≤1.25×ULN</description>
  </other_outcome>
  <other_outcome>
    <measure>Histological response</measure>
    <time_frame>24weeks</time_frame>
    <description>Liver tissue inflammatory necrosis score reduced by ≥2 points with no increased liver fibrosis score; liver fibrosis score reduced by ≥1 point</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>Hepalatide 2.1mg+Pegylated Interferon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hepalatide 4.2mg+Pegylated Interferon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hepalatide 6.3mg+Pegylated Interferon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo+Pegylated Interferon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hepalatide 2.1mg</intervention_name>
    <description>2.1 mg/day subcutaneously (s.c.) for 24 week</description>
    <arm_group_label>Hepalatide 2.1mg+Pegylated Interferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hepalatide 4.2mg</intervention_name>
    <description>4.2mg/day subcutaneously (s.c.) for 24 week</description>
    <arm_group_label>Hepalatide 4.2mg+Pegylated Interferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hepalatide 6.3mg</intervention_name>
    <description>6.3mg/day subcutaneously (s.c.) for 24 week</description>
    <arm_group_label>Hepalatide 6.3mg+Pegylated Interferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo 2.1mg</intervention_name>
    <description>2.1 mg/day subcutaneously (s.c.) for 24 week</description>
    <arm_group_label>placebo+Pegylated Interferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo 4.2mg</intervention_name>
    <description>4.2 mg/day subcutaneously (s.c.) for 24 week</description>
    <arm_group_label>placebo+Pegylated Interferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo 6.3mg</intervention_name>
    <description>6.3 mg/day subcutaneously (s.c.) for 24 week</description>
    <arm_group_label>placebo+Pegylated Interferon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegylated Interferon</intervention_name>
    <description>180 ug/week subcutaneously (s.c.) for 28 week</description>
    <arm_group_label>Hepalatide 2.1mg+Pegylated Interferon</arm_group_label>
    <arm_group_label>Hepalatide 4.2mg+Pegylated Interferon</arm_group_label>
    <arm_group_label>Hepalatide 6.3mg+Pegylated Interferon</arm_group_label>
    <arm_group_label>placebo+Pegylated Interferon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age from 18 to 60 years inclusively at the time of signing Informed Consent Form.&#xD;
&#xD;
          2. HBsAg or/and HBV DNA Positive for at least 6 months before Screening.&#xD;
&#xD;
          3. Subjects did not receive interferon treatment and did not receive&#xD;
             nucleotide/nucleoside analogue within 6 months&#xD;
&#xD;
          4. HBeAg positive or negative&#xD;
&#xD;
          5. HBV DNA≥20,000 IU/ml (HBeAg positive) or HBV DNA≥2,000 IU/ml (HBeAg negative)&#xD;
&#xD;
          6. 2×ULN ≤ALT≤10×ULN&#xD;
&#xD;
          7. Serum total bilirubin&lt;2×ULN&#xD;
&#xD;
          8. Subjects had no history of decompensated liver disease（Ascites, jaundice, hepatic&#xD;
             encephalopathy, varicose hemorrhage）, serious heart disease (including unstable or&#xD;
             uncontrolled heart disease within 6 months),serious mental illness (especially&#xD;
             depression),organ transplantation .subjects have no uncontrolled epilepsy, mental&#xD;
             illness, diabetes and hypertension,no autoimmune disease, immune related extrahepatic&#xD;
             manifestations (vasculitis, purpura, nodular arteritis, peripheral neuropathy and&#xD;
             glomerulonephritis), thyroid disease, malignant tumor, immunosuppressive therapy; no&#xD;
             basic diseases and other serious diseases such as serious infection, retinal disease,&#xD;
             heart failure and chronic obstructive pulmonary disease; no alcohol and drug abuse.&#xD;
&#xD;
          9. Subjects must agree to use a highly effective contraception for 2 years , female&#xD;
             subjects are not pregnant or breastfeeding&#xD;
&#xD;
         10. Subjects did not donate blood or as clinical trial subjects within 3 months before&#xD;
             screening&#xD;
&#xD;
         11. Subjects have good compliance with the protocol&#xD;
&#xD;
         12. Subjects understood and agreed to sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Decompensated liver disease: direct bilirubin &gt; 1.2 × ULN,&#xD;
&#xD;
          2. Prothrombin time &gt; 1.2 × ULN, serum albumin &lt; 35 g / L&#xD;
&#xD;
          3. Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or or&#xD;
             Child-Pugh score&gt; 7&#xD;
&#xD;
          4. Hemocytopenia: neutrophil &lt; 1 × 10^9 / L, platelet &lt; 50 × 10^9 / L, hemoglobin &lt; 100g&#xD;
             / L (female) or hemoglobin &lt; 110g / L (male) points&#xD;
&#xD;
          5. HAV,HCV,HDV,HEV or HIV infection&#xD;
&#xD;
          6. Pegylated interferon therapy is contraindicated&#xD;
&#xD;
          7. Allergic to interferon, Such as severe depression, epilepsy, autoimmune diseases,&#xD;
             uncontrolled thyroid dysfunction and so on&#xD;
&#xD;
          8. severe retinopathy or eye disease(Eye diseases due to high blood pressure or diabetes,&#xD;
             CMV retinitis, macular degeneration)&#xD;
&#xD;
          9. Positive for anti-HBV Pre-S1 antibody.&#xD;
&#xD;
         10. Hamilton Depression Scale (HAMD, 17 items) score &gt; 17 points&#xD;
&#xD;
         11. Female subjects pregnancy test positive&#xD;
&#xD;
         12. Other laboratories or auxiliary examinations are obviously abnormal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fusheng Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>The fifth medical center of PLA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaolu Tang</last_name>
    <phone>86-21-68412368</phone>
    <phone_ext>619</phone_ext>
    <email>tangxiaolu@heppharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xian Gao</last_name>
    <phone>86-21-68412368</phone>
    <phone_ext>620</phone_ext>
    <email>gaoxian@heppharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The fifth medical center of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Yu</last_name>
      <phone>010-66933460</phone>
    </contact>
    <investigator>
      <last_name>Fusheng Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jilin Hepatobiliary Disease Hospital</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Chen</last_name>
    </contact>
    <investigator>
      <last_name>Hui Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The first hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qinglong Jin</last_name>
    </contact>
    <investigator>
      <last_name>Qinglong Jin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chizhou People's Hospital</name>
      <address>
        <city>Chizhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoling Liu</last_name>
    </contact>
    <investigator>
      <last_name>Xiaoling Liu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital Affiliated to the Army Medical University</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qing Mao</last_name>
    </contact>
    <investigator>
      <last_name>Qing Mao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoping Wu</last_name>
    </contact>
    <investigator>
      <last_name>Xiaoping Wu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Nanjing</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Ye</last_name>
    </contact>
    <investigator>
      <last_name>Wei Ye</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Qingyuan People's Hospital</name>
      <address>
        <city>Qingyuan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bei Zhong</last_name>
    </contact>
    <investigator>
      <last_name>Bei Zhong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Tongren Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qin Zhang</last_name>
    </contact>
    <investigator>
      <last_name>Qin Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Sixth People's Hospital of Shenyang</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chengxin Meng</last_name>
    </contact>
    <investigator>
      <last_name>Chengxin Meng</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jia Shang</last_name>
    </contact>
    <investigator>
      <last_name>Jia Shang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henan Provincial Infectious Disease Hospital</name>
      <address>
        <city>Zhenzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guangmin Li</last_name>
    </contact>
    <investigator>
      <last_name>Guangmin Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 11, 2022</last_update_submitted>
  <last_update_submitted_qc>December 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</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>
  </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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04426968
org study id: L47-HB-II-02
nct id: NCT04426968
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect
      Relationship Study of Hepalatide for Injection Combined with Pegylated Interferon in Subjects
      with Chronic Hepatitis B
The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled,
      multicenter, dose-effect relationship, phase II clinical trial. The study is designed to
      assess efficacy and safety of 3 Doses of hepalatide in Combination with Pegylated Interferon
      Compared to Pegylated Interferon Alone in patients with Chronic Hepatitis B .Subjects will be
      randomly assigned to the 2.1mg, 4.2mg, and 6.3mg dose groups , 32 subjects in each group .
      The subjects in each dose group will be randomly and double-blindly administered the
      corresponding dose of trial drug or placebo in a ratio of 3:1. The subjects in each dose
      group who received placebo treatment combine as the placebo group. All subjects will receive
      Pegylated Interferon treatment for 28 weeks as the basic treatment,trial drug or placebo
      treatment for 24 weeks continuously , followed by a safety follow-up for 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: initial virological response
time frame: 24weeks
description: HBV DNA<20 IU/ml
measure: HBV DNA down from baseline
time frame: 24weeks
description: HBV DNA down from baseline log10
measure: Virological suppression
time frame: 24weeks
description: HBV DNA <2,000 IU/ml
measure: No response
time frame: 24weeks
description: HBsAg >20,000 IU/ml and HBV DNA lower than baseline <2log10 IU/ml
measure: Partial virological response
time frame: 24weeks
description: HBV DNA >20 IU/ml and ≥2log10 IU/ml lower than baseline
measure: HBsAg is down from baseline
time frame: 24weeks
description: HBsAg is down from baseline log10
measure: HBeAg turned negative
time frame: 24weeks
description: HBeAg <0.05 index
measure: HBeAg is down from baseline
time frame: 24weeks
description: HBeAg is down from baseline log10
measure: ALT recurrence
time frame: 24weeks
description: ALT≤1.25×ULN
measure: Histological response
time frame: 24weeks
description: Liver tissue inflammatory necrosis score reduced by ≥2 points with no increased liver fibrosis score; liver fibrosis score reduced by ≥1 point
arm group label: Hepalatide 2.1mg+Pegylated Interferon
arm group type: Experimental
arm group label: Hepalatide 4.2mg+Pegylated Interferon
arm group type: Experimental
arm group label: Hepalatide 6.3mg+Pegylated Interferon
arm group type: Experimental
arm group label: placebo+Pegylated Interferon
arm group type: Active Comparator
intervention type: Drug
intervention name: Hepalatide 2.1mg
description: 2.1 mg/day subcutaneously (s.c.) for 24 week
arm group label: Hepalatide 2.1mg+Pegylated Interferon
intervention type: Drug
intervention name: Hepalatide 4.2mg
description: 4.2mg/day subcutaneously (s.c.) for 24 week
arm group label: Hepalatide 4.2mg+Pegylated Interferon
intervention type: Drug
intervention name: Hepalatide 6.3mg
description: 6.3mg/day subcutaneously (s.c.) for 24 week
arm group label: Hepalatide 6.3mg+Pegylated Interferon
intervention type: Drug
intervention name: placebo 2.1mg
description: 2.1 mg/day subcutaneously (s.c.) for 24 week
arm group label: placebo+Pegylated Interferon
intervention type: Drug
intervention name: placebo 4.2mg
description: 4.2 mg/day subcutaneously (s.c.) for 24 week
arm group label: placebo+Pegylated Interferon
intervention type: Drug
intervention name: placebo 6.3mg
description: 6.3 mg/day subcutaneously (s.c.) for 24 week
arm group label: placebo+Pegylated Interferon
intervention type: Drug
intervention name: Pegylated Interferon
description: 180 ug/week subcutaneously (s.c.) for 28 week
arm group label: Hepalatide 2.1mg+Pegylated Interferon
arm group label: Hepalatide 4.2mg+Pegylated Interferon
arm group label: Hepalatide 6.3mg+Pegylated Interferon
arm group label: placebo+Pegylated Interferon
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Fusheng Wang
role: Principal Investigator
affiliation: The fifth medical center of PLA
last name: Xiaolu Tang
phone: 86-21-68412368
phone ext: 619
email: tangxiaolu@heppharma.com
last name: Xian Gao
phone: 86-21-68412368
phone ext: 620
email: gaoxian@heppharma.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Interferons
sharing ipd: No