<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/NCT02974179</url>
  </required_header>
  <id_info>
    <org_study_id>AG-CLI-0206-LTFU</org_study_id>
    <secondary_id>2016-003491-41</secondary_id>
    <nct_id>NCT02974179</nct_id>
  </id_info>
  <brief_title>A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia</brief_title>
  <official_title>A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AnGes USA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AnGes USA, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the&#xD;
      AG-CLI-0206-LTFU study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed to assess the long term safety of subjects who have been treated in the&#xD;
      phase 3 study with AMG0001. A health questionnaire will be used to collect specific&#xD;
      information from the subject every 6 months. Only those subjects that were randomized in the&#xD;
      AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term&#xD;
      follow-up study. Subjects that received placebo will not be eligible for participation in&#xD;
      this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001</measure>
    <time_frame>3 years from the date last subject randomized into AG-CLI-0206 study</time_frame>
    <description>A health questionnaire will be used to collect specific information from the subject every 6 months</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Subjects who received AMG0001</arm_group_label>
    <description>Subjects from Study AG-CLI-0206 who received the study product AMG0001</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Subjects from Study AG-CLI-0206 who received AMG0001</intervention_name>
    <description>Subjects from Study AG-CLI-0206 who received the study product AMG0001</description>
    <arm_group_label>Subjects who received AMG0001</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with critical limb ischemia who have previously been treated with AMG0001 in the&#xD;
        AG-CLI-0206 study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have been treated with AMG0001 in the AG-CLI-0206 study.&#xD;
&#xD;
          -  Subjects who have provided consent for this long term follow-up study either directly&#xD;
             or through a legally authorized representative.&#xD;
&#xD;
          -  Subjects who have provided a release of information to the sponsor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who were not enrolled in the AGCLI-0206 study.&#xD;
&#xD;
          -  Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001.&#xD;
&#xD;
          -  Subjects who have not provided consent to this long term follow-up study either&#xD;
             directly or through a legally authorized representative.&#xD;
&#xD;
          -  Subjects who have not provided a release of information for the Sponsor to contact&#xD;
             them directly via phone, email and/or mail.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Powell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</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>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02974179
org study id: AG-CLI-0206-LTFU
secondary id: 2016-003491-41
nct id: NCT02974179
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the
      AG-CLI-0206-LTFU study
The study is designed to assess the long term safety of subjects who have been treated in the
      phase 3 study with AMG0001. A health questionnaire will be used to collect specific
      information from the subject every 6 months. Only those subjects that were randomized in the
      AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term
      follow-up study. Subjects that received placebo will not be eligible for participation in
      this study.
observational model: Cohort
time perspective: Prospective
measure: Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001
time frame: 3 years from the date last subject randomized into AG-CLI-0206 study
description: A health questionnaire will be used to collect specific information from the subject every 6 months
arm group label: Subjects who received AMG0001
description: Subjects from Study AG-CLI-0206 who received the study product AMG0001
intervention type: Biological
intervention name: Subjects from Study AG-CLI-0206 who received AMG0001
description: Subjects from Study AG-CLI-0206 who received the study product AMG0001
arm group label: Subjects who received AMG0001
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Richard Powell, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
sharing ipd: No