<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/NCT02191540</url>
  </required_header>
  <id_info>
    <org_study_id>AB-MPE-2010</org_study_id>
    <nct_id>NCT02191540</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Abnoba Viscum F 20mg in Malignant Pleural Effusion Patients</brief_title>
  <official_title>A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abnoba Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abnoba Gmbh</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Abnoba Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of&#xD;
      Abnoba viscum F 20mg in patients with malignant pleural effusion&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy</measure>
    <time_frame>4 weeks</time_frame>
    <description>Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Malignant Pleural Effusion</condition>
  <arm_group>
    <arm_group_label>Abnoba Viscum F 20mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abnoba Viscum F 20mg</intervention_name>
    <description>intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space</description>
    <arm_group_label>Abnoba Viscum F 20mg</arm_group_label>
    <other_name>viscum album extract</other_name>
    <other_name>mistletoe extract</other_name>
    <other_name>abnobaVISCUM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject who need the pleurodesis among subjects diagnosed with a mlignant pleural&#xD;
             effusion&#xD;
&#xD;
          -  Full lung expansion must be achieved within 12 to 24 hours after drainage&#xD;
&#xD;
          -  Expected survival time of at least 2 months&#xD;
&#xD;
          -  Subject who score 50 or more on the Karnofsky Performance Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with previous attempts at pleurodesis with sclerosing agent&#xD;
&#xD;
          -  Subjects with trapped lung or bronchial obstruction&#xD;
&#xD;
          -  Subjects with adverse drug response to mistletoe agents&#xD;
&#xD;
          -  Subjects who have participated in another clinical study other than the present study&#xD;
&#xD;
          -  Subjects who is taking immune-suppressive agents&#xD;
&#xD;
          -  Subjects with medical and psychiatric contraindications for the study drug&#xD;
&#xD;
          -  Subjects who are not allowed to participate in the study by legal requirement&#xD;
&#xD;
          -  Subjects who are not allowed to participate in the study by the Investigator's&#xD;
             discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kook Joo Na, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonnam National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Friedemann Schad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FORSCHUNGSINSTITUT HAVELHOHE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>YongJik Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yeong Dae Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Busan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonnam National University Hwasun hospital</name>
      <address>
        <city>Hwasun gun</city>
        <state>Jeolla Namdo</state>
        <zip>519-763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Busan University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>682-714</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</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>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_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/NCT02191540
org study id: AB-MPE-2010
nct id: NCT02191540
lead sponsor: 
collaborator: 
has dmc: No
Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of
      Abnoba viscum F 20mg in patients with malignant pleural effusion
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy
time frame: 4 weeks
description: Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
arm group label: Abnoba Viscum F 20mg
arm group type: Experimental
intervention type: Drug
intervention name: Abnoba Viscum F 20mg
description: intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
arm group label: Abnoba Viscum F 20mg
other name: viscum album extract
other name: mistletoe extract
other name: abnobaVISCUM
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kook Joo Na, MD
role: Principal Investigator
affiliation: Chonnam National University Hospital
last name: Friedemann Schad, MD
role: Principal Investigator
affiliation: FORSCHUNGSINSTITUT HAVELHOHE
last name: YongJik Lee, MD
role: Principal Investigator
affiliation: Ulsan University Hospital
last name: Yeong Dae Kim, MD
role: Principal Investigator
affiliation: Busan University Hospital
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion