<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/NCT02968394</url>
  </required_header>
  <id_info>
    <org_study_id>NEVIT</org_study_id>
    <nct_id>NCT02968394</nct_id>
  </id_info>
  <brief_title>Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions</brief_title>
  <official_title>Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University Clinic of Pulmonary and Allergic Diseases Golnik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University Clinic of Pulmonary and Allergic Diseases Golnik</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction&#xD;
      of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to&#xD;
      systemic reactions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to&#xD;
      systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions.&#xD;
      High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to&#xD;
      systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure&#xD;
      patients will be co-treated with omalizumab during another attempt of immunotherapy&#xD;
      introduction. Patients will be clinically and immunologically followed up after the&#xD;
      introduction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</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>Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in basophil sensitivity during omalizumab co-treatment</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">11</enrollment>
  <condition>Allergy</condition>
  <condition>Bee Venom</condition>
  <condition>Immunotherapy</condition>
  <condition>Omalizumab</condition>
  <arm_group>
    <arm_group_label>NEVIT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Co treatment with omalizumab during another attempt of immunotherapy introduction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omalizumab</intervention_name>
    <arm_group_label>NEVIT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed&#xD;
             sensitization to honey-bee venom,&#xD;
&#xD;
          -  honey-bee venom immunotherapy treatment failure due to systemic reactions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic mastocytosis,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  use of beta-adrenergic blocking agents.&#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>Mitja Košnik, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Clinic of Pulmonary and Allergic Diseases Golnik</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Kopac, MD</last_name>
    <phone>+386 4 25 69 100</phone>
    <email>peter.kopac@klinika-golnik.si</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Clinic of Pulmonary and Allergic Diseases Golnik</name>
      <address>
        <city>Golnik</city>
        <zip>4204</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Kopac, MD</last_name>
      <phone>+386 4 25 69 100</phone>
      <email>peter.kopac@klinika-golnik.si</email>
    </contact>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</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/NCT02968394
org study id: NEVIT
nct id: NCT02968394
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction
      of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to
      systemic reactions.
Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to
      systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions.
      High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to
      systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure
      patients will be co-treated with omalizumab during another attempt of immunotherapy
      introduction. Patients will be clinically and immunologically followed up after the
      introduction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.
time frame: 2 months
measure: Changes in basophil sensitivity during omalizumab co-treatment
time frame: 2 years
arm group label: NEVIT
arm group type: Experimental
description: Co treatment with omalizumab during another attempt of immunotherapy introduction
intervention type: Drug
intervention name: omalizumab
arm group label: NEVIT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mitja Košnik, MD, PhD
role: Study Director
affiliation: University Clinic of Pulmonary and Allergic Diseases Golnik
last name: Peter Kopac, MD
phone: +386 4 25 69 100
email: peter.kopac@klinika-golnik.si
facility: 
status: Recruiting
contact: 
country: Slovenia
responsible party type: Sponsor
mesh term: Omalizumab