<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/NCT03020810</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16120334</org_study_id>
    <nct_id>NCT03020810</nct_id>
  </id_info>
  <brief_title>Dupilumab Compassionate Use Study</brief_title>
  <official_title>Dupilumab Compassionate Use Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sally E. Wenzel MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <brief_summary>
    <textblock>
      This is a single patient expanded access, compassionate and non-emergency use study that&#xD;
      provides patients with severe asthma, who do not qualify for ongoing clinical trials with&#xD;
      dupilumab, access to this investigational treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being undertaken to determine whether dupilumab has efficacy in extremely&#xD;
      severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every&#xD;
      immunosuppressive drug, early access to a potentially effective therapy.&#xD;
&#xD;
      The patient will continue in the study indefinitely. Safety will be evaluated and serious&#xD;
      adverse events will be reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Asthma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dupilumab</intervention_name>
    <description>The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sever systemic corticosteroid dependent asthma for more than 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease other than asthma&#xD;
&#xD;
          -  Circulation eosinophils more than 1500/ul&#xD;
&#xD;
          -  Current smoker or more than 10 pack years&#xD;
&#xD;
        This is a single-patient study. The University of Pittsburgh site is not enrolling new&#xD;
        patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Sally E. Wenzel MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <!-- 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/NCT03020810
org study id: PRO16120334
nct id: NCT03020810
lead sponsor: 
This is a single patient expanded access, compassionate and non-emergency use study that
      provides patients with severe asthma, who do not qualify for ongoing clinical trials with
      dupilumab, access to this investigational treatment.
This study is being undertaken to determine whether dupilumab has efficacy in extremely
      severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every
      immunosuppressive drug, early access to a potentially effective therapy.

      The patient will continue in the study indefinitely. Safety will be evaluated and serious
      adverse events will be reported.
intervention type: Drug
intervention name: Dupilumab
description: The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Sally E. Wenzel MD
investigator title: Professor of Medicine