<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/NCT01719133</url>
  </required_header>
  <id_info>
    <org_study_id>AN002</org_study_id>
    <nct_id>NCT01719133</nct_id>
  </id_info>
  <brief_title>Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen</brief_title>
  <official_title>Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anergis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anergis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the&#xD;
      major birch allergen bet v 1, in subjects allergic to birch pollen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study tested - all by skin tests - in the same group of 20 trial subjects, one positive&#xD;
      control (histamine solution), one negative control (placebo saline) and five experimental&#xD;
      peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as&#xD;
      negative (no reaction) or positive (wheal diameter &gt; 4 mm with erythema)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">June 2008</completion_date>
  <primary_completion_date type="Actual">March 2008</primary_completion_date>
  <phase>Phase 1</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>skin prick test reactivity</measure>
    <time_frame>15 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>All subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>saline solution</description>
    <arm_group_label>All subjects</arm_group_label>
    <other_name>saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Histamine</intervention_name>
    <description>positive control</description>
    <arm_group_label>All subjects</arm_group_label>
    <other_name>Histamine solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT1</intervention_name>
    <description>synthetic peptide T1</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT2</intervention_name>
    <description>synthetic peptide T2</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT3</intervention_name>
    <description>synthetic peptide T3</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT4</intervention_name>
    <description>synthetic peptide T4</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AllerT5</intervention_name>
    <description>synthetic peptide T5</description>
    <arm_group_label>All subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mix of AllerT1-T2-T3</intervention_name>
    <description>mix of peptides T1, T2 and T3</description>
    <arm_group_label>All subjects</arm_group_label>
    <other_name>AllerT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mix of AllerT4-T5</intervention_name>
    <description>mix T4-T5</description>
    <arm_group_label>All subjects</arm_group_label>
    <other_name>mix T4-T5</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of allergy symptoms during previous birch pollen season&#xD;
&#xD;
          -  positive skin prick test to birch pollen extract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  uncontrolled asthma&#xD;
&#xD;
          -  other significant clinical conditions or immune disorders&#xD;
&#xD;
          -  subjects taking antihistamines or drugs with antihistamine activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francois Spertini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 31, 2012</last_update_submitted>
  <last_update_submitted_qc>October 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>allergy</keyword>
  <keyword>birch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Histamine</mesh_term>
    <mesh_term>Histamine phosphate</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/NCT01719133
org study id: AN002
nct id: NCT01719133
lead sponsor: 
has dmc: No
Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the
      major birch allergen bet v 1, in subjects allergic to birch pollen.
The study tested - all by skin tests - in the same group of 20 trial subjects, one positive
      control (histamine solution), one negative control (placebo saline) and five experimental
      peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as
      negative (no reaction) or positive (wheal diameter > 4 mm with erythema)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: skin prick test reactivity
time frame: 15 minutes
arm group label: All subjects
arm group type: Other
description: placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
intervention type: Drug
intervention name: placebo
description: saline solution
arm group label: All subjects
other name: saline
intervention type: Drug
intervention name: Histamine
description: positive control
arm group label: All subjects
other name: Histamine solution
intervention type: Drug
intervention name: AllerT1
description: synthetic peptide T1
arm group label: All subjects
intervention type: Drug
intervention name: AllerT2
description: synthetic peptide T2
arm group label: All subjects
intervention type: Drug
intervention name: AllerT3
description: synthetic peptide T3
arm group label: All subjects
intervention type: Drug
intervention name: AllerT4
description: synthetic peptide T4
arm group label: All subjects
intervention type: Drug
intervention name: AllerT5
description: synthetic peptide T5
arm group label: All subjects
intervention type: Drug
intervention name: mix of AllerT1-T2-T3
description: mix of peptides T1, T2 and T3
arm group label: All subjects
other name: AllerT
intervention type: Drug
intervention name: mix of AllerT4-T5
description: mix T4-T5
arm group label: All subjects
other name: mix T4-T5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Francois Spertini, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Histamine
mesh term: Histamine phosphate