<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/NCT03236584</url>
  </required_header>
  <id_info>
    <org_study_id>UC15MISI0099</org_study_id>
    <nct_id>NCT03236584</nct_id>
  </id_info>
  <brief_title>Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir</brief_title>
  <official_title>Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uijeongbu St. Mary Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uijeongbu St. Mary Hospital</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>
      Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant&#xD;
      chronic hepatitis B patients who achieved a complete virological response to lamivudine plus&#xD;
      adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy&#xD;
      for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus&#xD;
      DNA while on lamivudine plus adefovir combination therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Anticipated">March 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2018</primary_completion_date>
  <phase>Phase 3</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>SVR</measure>
    <time_frame>48 WEEK</time_frame>
    <description>Proportion of patients with a sustained virological response (serum HBV DNA &lt;20 IU/mL) at week 48</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Proportion of Patients With a Sustained Virological Response (Serum HBV DNA &lt;20 IU/mL) at Week 48</condition>
  <arm_group>
    <arm_group_label>lamivudine adefovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>tenofovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lamivudine plus adefovir combination</intervention_name>
    <description>continuing lamivudine plus adefovir</description>
    <arm_group_label>lamivudine adefovir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir Disoproxil Fumarate</intervention_name>
    <description>switching to tenofovir</description>
    <arm_group_label>tenofovir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HBsAg (+) for &gt; 6 months age &gt;19 years antiviral resistance to LAM (rtL180M and/or&#xD;
             M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels &lt;20&#xD;
             IU/ml on two consecutive tests of 3-month interval&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection&#xD;
             with HIV, HCV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uijeongbu St. Mary Hospital</investigator_affiliation>
    <investigator_full_name>Chang Wook Kim</investigator_full_name>
    <investigator_title>C.W. Kim</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, 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>Lamivudine</mesh_term>
    <mesh_term>Adefovir</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/NCT03236584
org study id: UC15MISI0099
nct id: NCT03236584
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant
      chronic hepatitis B patients who achieved a complete virological response to lamivudine plus
      adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy
      for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus
      DNA while on lamivudine plus adefovir combination therapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SVR
time frame: 48 WEEK
description: Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48
arm group label: lamivudine adefovir
arm group type: Active Comparator
arm group label: tenofovir
arm group type: Experimental
intervention type: Drug
intervention name: lamivudine plus adefovir combination
description: continuing lamivudine plus adefovir
arm group label: lamivudine adefovir
intervention type: Drug
intervention name: Tenofovir Disoproxil Fumarate
description: switching to tenofovir
arm group label: tenofovir
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Uijeongbu St. Mary Hospital
investigator full name: Chang Wook Kim
investigator title: C.W. Kim
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Tenofovir
mesh term: Lamivudine
mesh term: Adefovir
sharing ipd: No