<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/NCT03792919</url>
  </required_header>
  <id_info>
    <org_study_id>VENI-1</org_study_id>
    <nct_id>NCT03792919</nct_id>
  </id_info>
  <brief_title>Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)</brief_title>
  <official_title>Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humanity &amp; Health Medical Group Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Humanity &amp; Health Medical Group Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome&#xD;
      including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB)&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis&#xD;
      B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown&#xD;
      to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss&#xD;
      rate is low even after long-term NAs treatment. Recent studies indicated that cessation of&#xD;
      NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can&#xD;
      stop NAs safely with satisfactory clinical outcome including sustain viral remission and&#xD;
      HBsAg clearance is very important.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Participants will be randomized to 2 groups. Group 1: Stop current anti-HBV neucleos(t)ides treatment, Group 2: Keep on current anti-HBV nucleus(t)ides treatment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of HBsAg clearance</measure>
    <time_frame>From baseline to the end of the fifth year after cessation of anti-HBV treatment.</time_frame>
    <description>The incidence of HBsAg clearance during the off-treatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of HBsAg seroconversion</measure>
    <time_frame>From baseline to the end of the fifth year after cessation of anti-HBV treatment.</time_frame>
    <description>The incidence of HBsAg seroconversion during the off-treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of sustain HBV viral submission</measure>
    <time_frame>rom baseline to the end of the fifth year after cessation of anti-HBV treatment.</time_frame>
    <description>The incidence of sustain HBV viral submission during the off-treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of sustain biological response</measure>
    <time_frame>rom baseline to the end of the fifth year after cessation of anti-HBV treatment.</time_frame>
    <description>The incidence of sustain biological response during the off-treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hepatocellular carcinoma</measure>
    <time_frame>rom baseline to the end of the fifth year after cessation of anti-HBV treatment.</time_frame>
    <description>The incidence of hepatocellular carcinoma during the off-treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Liver failure</measure>
    <time_frame>rom baseline to the end of the fifth year after cessation of anti-HBV treatment.</time_frame>
    <description>The incidence of Liver failure during the off-treatment period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Cessation of NAs treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic hepatitis B patients who meet the criteria to stop the current anti-HBV Neucleos(t)ides treatment will stop their NAs at the baseline of the clinical trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Keep on current NAs treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chronic hepatitis B patients who meet the criteria to stop anti-HBV Neucleos(t)ides treatment will choose to keep on their current NAs treatment from the baseline of the clinical trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stop current treatment (anti-HBV neucleos(t)ides)</intervention_name>
    <description>Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.</description>
    <arm_group_label>Cessation of NAs treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Keep current treatment (anti-HBV neucleos(t)ides)</intervention_name>
    <description>Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.</description>
    <arm_group_label>Keep on current NAs treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HBsAg positive, HBeAg negative, antibody to HBeAg-positive;&#xD;
&#xD;
          2. Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least&#xD;
             more than one and a half year;&#xD;
&#xD;
          3. Demonstration of undetectable HBV DNA on three occasions, each at least 6 months&#xD;
             apart, which is consistent with the APASL stopping rule;&#xD;
&#xD;
          4. Patients read, understand the consent form, and signed the study consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with other liver diseases;&#xD;
&#xD;
          2. Patient with concurrent hepatitis viruses or HIV infection;&#xD;
&#xD;
          3. Patients are reluctant to stop their anti-HBV treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>George Lau, MD</last_name>
    <phone>852-28613777</phone>
    <email>gkklau@netvigator.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Danny Wang</last_name>
    <phone>852-28613777</phone>
    <email>danny.wang@hnhmgl.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Humanity &amp; Health Research Centre</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong SAR</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Danny Wang</last_name>
      <phone>852-28613777</phone>
      <email>danny.wang@hnhmgl.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 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 B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_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/NCT03792919
org study id: VENI-1
nct id: NCT03792919
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome
      including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB)
      patients.
Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis
      B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown
      to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss
      rate is low even after long-term NAs treatment. Recent studies indicated that cessation of
      NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can
      stop NAs safely with satisfactory clinical outcome including sustain viral remission and
      HBsAg clearance is very important.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to 2 groups. Group 1: Stop current anti-HBV neucleos(t)ides treatment, Group 2: Keep on current anti-HBV nucleus(t)ides treatment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of HBsAg clearance
time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
description: The incidence of HBsAg clearance during the off-treatment period
measure: Incidence of HBsAg seroconversion
time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
description: The incidence of HBsAg seroconversion during the off-treatment period
measure: Incidence of sustain HBV viral submission
time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
description: The incidence of sustain HBV viral submission during the off-treatment period
measure: Incidence of sustain biological response
time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
description: The incidence of sustain biological response during the off-treatment period
measure: Incidence of hepatocellular carcinoma
time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
description: The incidence of hepatocellular carcinoma during the off-treatment period
measure: Incidence of Liver failure
time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
description: The incidence of Liver failure during the off-treatment period
arm group label: Cessation of NAs treatment
arm group type: Experimental
description: Chronic hepatitis B patients who meet the criteria to stop the current anti-HBV Neucleos(t)ides treatment will stop their NAs at the baseline of the clinical trial.
arm group label: Keep on current NAs treatment
arm group type: Active Comparator
description: Chronic hepatitis B patients who meet the criteria to stop anti-HBV Neucleos(t)ides treatment will choose to keep on their current NAs treatment from the baseline of the clinical trial.
intervention type: Drug
intervention name: Stop current treatment (anti-HBV neucleos(t)ides)
description: Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
arm group label: Cessation of NAs treatment
intervention type: Drug
intervention name: Keep current treatment (anti-HBV neucleos(t)ides)
description: Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
arm group label: Keep on current NAs treatment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: George Lau, MD
phone: 852-28613777
email: gkklau@netvigator.com
last name: Danny Wang
phone: 852-28613777
email: danny.wang@hnhmgl.com
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
sharing ipd: No