<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/NCT02202473</url>
  </required_header>
  <id_info>
    <org_study_id>Oxymatrine</org_study_id>
    <nct_id>NCT02202473</nct_id>
  </id_info>
  <brief_title>Oxymatrine Plus Lamivudine Combination Therapy Versus Lamivudine Monotherapy for Chronic Hepatitis B Infected Subjects</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cttq</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine&#xD;
      Combination Therapy and whether it could lower the incidence of Lamivudine long-term&#xD;
      resistance compared to Lamivudine Monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Group A (Lamivudine Monotherapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd.&#xD;
&#xD;
      Group B (Oxymatrine + Lamivudine Combination Therapy): Lamivudine (Manufacturer:&#xD;
      GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group&#xD;
      Co., Ltd) 200 mg, po, tid.&#xD;
&#xD;
      Total subjects: 200, 100 patients randomized in each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months</measure>
    <time_frame>1, 3, 6, 12, 15, 18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hepatitis B virus resistance loci</measure>
    <time_frame>1, 3, 6, 12, 15, 18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Lamivudine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lamivudine+Oxymatrine Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lamivudine</intervention_name>
    <arm_group_label>Lamivudine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lamivudine+Oxymatrine Capsules</intervention_name>
    <arm_group_label>Lamivudine+Oxymatrine Capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 to 60 years old.&#xD;
&#xD;
          2. Subjects diagnosed as chronic hepatitis B according to 2000 Xi'an Conference&#xD;
             Guidelines: Management of chronic hepatitis B. Alanine transaminase &gt;80 IU/L, total&#xD;
             bilirubin&lt;85.5 mmol/L, Hepatitis B virus DNA &gt;1×10^5copies/mL; haven't been treated&#xD;
             with antiviral therapy within 6 months before screening.&#xD;
&#xD;
          3. able to give written informed consent and to comply with the study protocol.&#xD;
&#xD;
          4. Women of childbearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of hepatocellular carcinoma&#xD;
&#xD;
          2. Clinical symptoms of Decompensated liver disease at screening, including but not&#xD;
             limited to: Serum bilirubin≥1.5 x upper limit of normal, prothrombin time of greater&#xD;
             than 2 seconds prolonged, a serum albumin&lt; 32g/L, or a history of ascites, variceal&#xD;
             bleeding, or hepatic encephalopathy;&#xD;
&#xD;
          3. Alanine transaminase&gt;10 x upper limit of normal at screening or history of Transient&#xD;
             hepatic decompensation caused by acute exacerbation;&#xD;
&#xD;
          4. hemoglobin&lt; 10g/dL, Neutrophil count&lt;1.5 × 10^9/L, platelet count&lt; 80 × 10^9/L;&#xD;
&#xD;
          5. Evidence of active liver disease from other causes, including co-infection with&#xD;
             hepatitis A virus, co-infection with hepatitis E virus, co-infection with hepatitis C&#xD;
             virus, co-infection with hepatitis D virus, co-infection with HIV, autoimmune&#xD;
             hepatitis (antinuclear antibody titer&gt; 1:100);&#xD;
&#xD;
          6. Use of immunosuppressors, immunomodulators (including interferon or thymosin) within 6&#xD;
             months before enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>the second hospital of Nanjing</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available.</citation>
    <PMID>19187608</PMID>
  </reference>
  <reference>
    <citation>Yuen MF, Fung J, Wong DK, Lai CL. Prevention and management of drug resistance for antihepatitis B treatment. Lancet Infect Dis. 2009 Apr;9(4):256-64. doi: 10.1016/S1473-3099(09)70056-8.</citation>
    <PMID>19324298</PMID>
  </reference>
  <reference>
    <citation>Wang YP, Zhao W, Xue R, Zhou ZX, Liu F, Han YX, Ren G, Peng ZG, Cen S, Chen HS, Li YH, Jiang JD. Oxymatrine inhibits hepatitis B infection with an advantage of overcoming drug-resistance. Antiviral Res. 2011 Mar;89(3):227-31. doi: 10.1016/j.antiviral.2011.01.005. Epub 2011 Jan 28.</citation>
    <PMID>21277330</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Wei Zhao</investigator_full_name>
    <investigator_title>director of the hospital</investigator_title>
  </responsible_party>
  <keyword>Oxymatrine Capsules, lamivudine, chronic Hepatitis B</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Oxymatrine</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/NCT02202473
org study id: Oxymatrine
nct id: NCT02202473
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine
      Combination Therapy and whether it could lower the incidence of Lamivudine long-term
      resistance compared to Lamivudine Monotherapy.
Group A (Lamivudine Monotherapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd.

      Group B (Oxymatrine + Lamivudine Combination Therapy): Lamivudine (Manufacturer:
      GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group
      Co., Ltd) 200 mg, po, tid.

      Total subjects: 200, 100 patients randomized in each group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months
time frame: 1, 3, 6, 12, 15, 18 months
measure: Hepatitis B virus resistance loci
time frame: 1, 3, 6, 12, 15, 18 months
arm group label: Lamivudine
arm group type: Active Comparator
description: Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd
arm group label: Lamivudine+Oxymatrine Capsules
arm group type: Experimental
description: Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.
intervention type: Drug
intervention name: Lamivudine
arm group label: Lamivudine
intervention type: Drug
intervention name: Lamivudine+Oxymatrine Capsules
arm group label: Lamivudine+Oxymatrine Capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: China
citation: Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available.
PMID: 19187608
citation: Yuen MF, Fung J, Wong DK, Lai CL. Prevention and management of drug resistance for antihepatitis B treatment. Lancet Infect Dis. 2009 Apr;9(4):256-64. doi: 10.1016/S1473-3099(09)70056-8.
PMID: 19324298
citation: Wang YP, Zhao W, Xue R, Zhou ZX, Liu F, Han YX, Ren G, Peng ZG, Cen S, Chen HS, Li YH, Jiang JD. Oxymatrine inhibits hepatitis B infection with an advantage of overcoming drug-resistance. Antiviral Res. 2011 Mar;89(3):227-31. doi: 10.1016/j.antiviral.2011.01.005. Epub 2011 Jan 28.
PMID: 21277330
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Wei Zhao
investigator title: director of the hospital
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Lamivudine
mesh term: Oxymatrine