<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/NCT02185183</url>
  </required_header>
  <id_info>
    <org_study_id>YI2014-HMO-CTIL</org_study_id>
    <nct_id>NCT02185183</nct_id>
  </id_info>
  <brief_title>Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)</brief_title>
  <official_title>Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will&#xD;
      be tested in patients with inflammatory bowel disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral administration of Alequel prepared from patients biopsies will be tested in patients&#xD;
      with inflammatory bowel disease to determine its anti inflammatory effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">January 2010</completion_date>
  <primary_completion_date type="Actual">January 2010</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Improved in Disease Activity</measure>
    <time_frame>15 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>AlequelTM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AlequelTM</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alequel</intervention_name>
    <description>Alequel</description>
    <arm_group_label>AlequelTM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Crohn's disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immune suppression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaron Ilan, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <verification_date>January 2008</verification_date>
  <study_first_submitted>April 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>September 7, 2014</results_first_submitted>
  <results_first_submitted_qc>September 17, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 22, 2014</results_first_posted>
  <last_update_submitted>September 21, 2014</last_update_submitted>
  <last_update_submitted_qc>September 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 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>Crohn Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AlequelTM 30 ng Once a Day Orally</title>
          <description>AlequelTM 30 ng once a day orally&#xD;
Alequel: Alequel</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AlequelTM</title>
          <description>AlequelTM&#xD;
Alequel: Alequel</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" lower_limit="26" upper_limit="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>14 participants followed for improvement of disease</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Crohn's disease activity index</title>
          <description>On a sclae of 100 to 400, a decrease in the score suggests improvement of disease activity</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="303" lower_limit="100" upper_limit="400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Improved in Disease Activity</title>
        <time_frame>15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AlequelTM</title>
            <description>AlequelTM&#xD;
Alequel: Alequel</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Improved in Disease Activity</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>AlequelTM</title>
          <description>AlequelTM&#xD;
Alequel: Alequel</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Elazar Rabbani</name_or_title>
      <organization>ENZO</organization>
      <phone>2125830100</phone>
      <email>erabbani@enzo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02185183
org study id: YI2014-HMO-CTIL
nct id: NCT02185183
lead sponsor: 
has dmc: No
Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will
      be tested in patients with inflammatory bowel disease.
Oral administration of Alequel prepared from patients biopsies will be tested in patients
      with inflammatory bowel disease to determine its anti inflammatory effect.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Improved in Disease Activity
time frame: 15 weeks
arm group label: AlequelTM
arm group type: Experimental
description: AlequelTM
intervention type: Drug
intervention name: Alequel
description: Alequel
arm group label: AlequelTM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yaron Ilan, M.D.
role: Study Director
affiliation: Hadassah Medical Organization
responsible party type: Sponsor
mesh term: Crohn Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 