<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/NCT01679912</url>
  </required_header>
  <id_info>
    <org_study_id>P110109</org_study_id>
    <secondary_id>2012-A00044-39</secondary_id>
    <nct_id>NCT01679912</nct_id>
  </id_info>
  <brief_title>A Call Center During HAE Attacks (SOS HAE)</brief_title>
  <acronym>SOS AOH</acronym>
  <official_title>Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial aims to compare morbidity and cost associated with acute attacks of&#xD;
      hereditary angioedema in patients with an intervention based on a support after a phone call&#xD;
      to the call center (SOS HAE) from a group of patients does not change their practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators propose a study to determine whether a call center for an acute attack of HAE&#xD;
      associated with intervention recommendations based on systematic early treatment&#xD;
      (self-administration at home or by a caregiver) would reduce the morbidity and the&#xD;
      socioeconomic impact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of hospital admissions for angioedema attack- no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of ICU admissions - no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ED admissions - no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions for others causes - no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of intubations - no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of EMS interventions - no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of working days lost</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality - no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality for angioedema attack- no (%)</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of angioedema attacks</measure>
    <time_frame>at 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Hereditary Angioedema</condition>
  <arm_group>
    <arm_group_label>1: phone to call center</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>recommendations to phone to the call center for all the patients who have an acute attack</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2: usual strategy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual strategy. No intervention (patients does not change their practice)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phone to the call center</intervention_name>
    <description>recommendations to phone to the call center for all the patients who have an acute attack</description>
    <arm_group_label>1: phone to call center</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an hereditary angioedema followed in a reference center for bradykinin&#xD;
             angioedema (CRéAk)&#xD;
&#xD;
          -  Patient's age ≥ 18 years&#xD;
&#xD;
          -  Consent to the participation in the study&#xD;
&#xD;
          -  Affiliated to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  recent history of myocardial infarction&#xD;
&#xD;
          -  recent history of stroke&#xD;
&#xD;
          -  allergy to icatibant or C1 inhibitor concentrate&#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>Frédéric ADNET, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SAMU 93 - Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <state>Ile de France</state>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hereditary angioedema</keyword>
  <keyword>Emergency Medical Service</keyword>
  <keyword>Health care coast</keyword>
  <keyword>Telephone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angioedema</mesh_term>
    <mesh_term>Angioedemas, Hereditary</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/NCT01679912
org study id: P110109
secondary id: 2012-A00044-39
nct id: NCT01679912
lead sponsor: 
has dmc: Yes
This clinical trial aims to compare morbidity and cost associated with acute attacks of
      hereditary angioedema in patients with an intervention based on a support after a phone call
      to the call center (SOS HAE) from a group of patients does not change their practice.
Investigators propose a study to determine whether a call center for an acute attack of HAE
      associated with intervention recommendations based on systematic early treatment
      (self-administration at home or by a caregiver) would reduce the morbidity and the
      socioeconomic impact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of hospital admissions for angioedema attack- no (%)
time frame: at 2 years
measure: Number of ICU admissions - no (%)
time frame: at 2 years
measure: Number of ED admissions - no (%)
time frame: at 2 years
measure: Number of hospital admissions for others causes - no (%)
time frame: at 2 years
measure: Number of intubations - no (%)
time frame: at 2 years
measure: Number of EMS interventions - no (%)
time frame: at 2 years
measure: Number of working days lost
time frame: at 2 years
measure: Mortality - no (%)
time frame: at 2 years
measure: Mortality for angioedema attack- no (%)
time frame: at 2 years
measure: Cost of angioedema attacks
time frame: at 2 years
arm group label: 1: phone to call center
arm group type: Experimental
description: recommendations to phone to the call center for all the patients who have an acute attack
arm group label: 2: usual strategy
arm group type: No Intervention
description: usual strategy. No intervention (patients does not change their practice)
intervention type: Other
intervention name: phone to the call center
description: recommendations to phone to the call center for all the patients who have an acute attack
arm group label: 1: phone to call center
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frédéric ADNET, MD,PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Angioedema
mesh term: Angioedemas, Hereditary