<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/NCT02186574</url>
  </required_header>
  <id_info>
    <org_study_id>JF62014</org_study_id>
    <nct_id>NCT02186574</nct_id>
  </id_info>
  <brief_title>Tenofovir to Prevent HBV Reactivation</brief_title>
  <official_title>A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine how effective preemptive tenofovir therapy is in&#xD;
      preventing the re-activation of Hepatitis B infection, in patients who are receiving&#xD;
      rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation&#xD;
      will be compared between patients who receive preemptive tenofovir and patients who receive&#xD;
      tenofovir as needed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of reverse seroconversion</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
    <description>The difference in the rate of reverse seroconversion or Hepatitis B (HBV)-associated hepatitis (definition: appearance of HBsAg in the serum with or without detectable HBV DNA in a patient who was previously HBsAg-/cAb+.) between the intervention and placebo groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of HBV Reactivation</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe HBV-associated hepatitis</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBV-related liver failure</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver-related death</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related adverse effects (AEs)</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to start chemotherapy</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy interruption</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>12 months post-chemotherapy</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Hepatitis B</condition>
  <condition>Lymphoma</condition>
  <condition>Non-Hodgkin</condition>
  <arm_group>
    <arm_group_label>Pre-emptive tenofovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tenofovir disoproxil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir disoproxil</intervention_name>
    <arm_group_label>Pre-emptive tenofovir</arm_group_label>
    <other_name>Viread</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years of age&#xD;
&#xD;
          2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy&#xD;
&#xD;
          3. HBsAg negative, anti-HBc positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current therapy with known activity against HBV&#xD;
&#xD;
          2. Screening ALT &gt; 10 x ULN&#xD;
&#xD;
          3. Screening ALT &gt;2 and &lt;10 xULN with HBV DNA &gt; 2000 IU/mL (indicates active HBV&#xD;
             infection despite HBsAg negative and require antiviral therapy)&#xD;
&#xD;
          4. Life expectancy &lt; 3 months&#xD;
&#xD;
          5. HBsAg positive&#xD;
&#xD;
          6. HIV co-infection&#xD;
&#xD;
          7. Active HCV co-infection (HCV RNA positive)&#xD;
&#xD;
          8. Creatinine clearance &lt;50 mL/min&#xD;
&#xD;
          9. Intolerance to tenofovir&#xD;
&#xD;
         10. Women of child-bearing potential unwilling to take contraception during the study&#xD;
             period&#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>Harry Janssen, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jordan Feld, MD</last_name>
    <phone>416-340-4584</phone>
    <email>jordan.feld@uhn.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jamuna Nanthakumar, CCRP</last_name>
    <phone>416-340-4800</phone>
    <phone_ext>6453</phone_ext>
    <email>jnanthak@uhnresearch.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nimisha Dave, BSc</last_name>
      <phone>416-946-4501</phone>
      <phone_ext>4753</phone_ext>
      <email>nimisha.dave@uhn.ca</email>
    </contact>
    <contact_backup>
      <last_name>Ruth Turner, RN</last_name>
      <phone>416-946-2987</phone>
      <email>ruth.turner@uhn.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Michael Crump, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>December 10, 2019</last_update_submitted>
  <last_update_submitted_qc>December 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-Hodgkin</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Hepatitis B</keyword>
  <keyword>Tenofovir</keyword>
  <keyword>Viread</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>Lymphoma</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</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/NCT02186574
org study id: JF62014
nct id: NCT02186574
lead sponsor: 
has dmc: Yes
The purpose of the study is to determine how effective preemptive tenofovir therapy is in
      preventing the re-activation of Hepatitis B infection, in patients who are receiving
      rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation
      will be compared between patients who receive preemptive tenofovir and patients who receive
      tenofovir as needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Rate of reverse seroconversion
time frame: 12 months post-chemotherapy
description: The difference in the rate of reverse seroconversion or Hepatitis B (HBV)-associated hepatitis (definition: appearance of HBsAg in the serum with or without detectable HBV DNA in a patient who was previously HBsAg-/cAb+.) between the intervention and placebo groups.
measure: Rates of HBV Reactivation
time frame: 12 months post-chemotherapy
measure: Severe HBV-associated hepatitis
time frame: 12 months post-chemotherapy
measure: HBV-related liver failure
time frame: 12 months post-chemotherapy
measure: Liver-related death
time frame: 12 months post-chemotherapy
measure: Treatment-related adverse effects (AEs)
time frame: 12 months post-chemotherapy
measure: Time to start chemotherapy
time frame: 12 months post-chemotherapy
measure: Chemotherapy interruption
time frame: 12 months post-chemotherapy
measure: All-cause mortality
time frame: 12 months post-chemotherapy
arm group label: Pre-emptive tenofovir
arm group type: Active Comparator
description: Tenofovir disoproxil
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Tenofovir disoproxil
arm group label: Pre-emptive tenofovir
other name: Viread
intervention type: Drug
intervention name: Placebo Oral Tablet
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harry Janssen, MD
role: Study Director
affiliation: University Health Network, Toronto
last name: Jordan Feld, MD
phone: 416-340-4584
email: jordan.feld@uhn.ca
last name: Jamuna Nanthakumar, CCRP
phone: 416-340-4800
phone ext: 6453
email: jnanthak@uhnresearch.ca
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Lymphoma
mesh term: Hepatitis
mesh term: Tenofovir