<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/NCT03834376</url>
  </required_header>
  <id_info>
    <org_study_id>CR108461</org_study_id>
    <secondary_id>63623872FLZ4001</secondary_id>
    <nct_id>NCT03834376</nct_id>
  </id_info>
  <brief_title>Pre-Approval Access to Pimodivir for the Treatment of Patients With H7N9 Influenza A Infection</brief_title>
  <official_title>Pimodivir (JNJ-63623872) Pre Approval Access_Single Patient Access (SPR) for Patients Diagnosed With H7N9 Influenza A Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <brief_summary>
    <textblock>
      The purpose of this program is to provide pre-approval access to pimodivir for the treatment&#xD;
      of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision&#xD;
      for therapeutic use of an investigational product prior to its marketing authorization. Such&#xD;
      access may be considered for eligible patients with serious/life-threatening diseases or&#xD;
      conditions, where alternative treatments do not exist or have been exhausted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>H7N9 Subtype of Influenza A Virus</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pimodivir</intervention_name>
    <description>Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days.</description>
    <other_name>JNJ-63623872</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has an H7N9 Influenza A infection&#xD;
&#xD;
          -  The patient has no known severe hepatic impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Any other Influenza A sub-strains other than H7N9&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>October 27, 2020</last_update_submitted>
  <last_update_submitted_qc>October 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 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>Influenza, Human</mesh_term>
    <mesh_term>Influenza in Birds</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/NCT03834376
org study id: CR108461
secondary id: 63623872FLZ4001
nct id: NCT03834376
lead sponsor: 
The purpose of this program is to provide pre-approval access to pimodivir for the treatment
      of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision
      for therapeutic use of an investigational product prior to its marketing authorization. Such
      access may be considered for eligible patients with serious/life-threatening diseases or
      conditions, where alternative treatments do not exist or have been exhausted.
expanded access type individual: Yes
intervention type: Drug
intervention name: Pimodivir
description: Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days.
other name: JNJ-63623872
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
country: United Kingdom
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Influenza in Birds