<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/NCT03265171</url>
  </required_header>
  <id_info>
    <org_study_id>2002C013G</org_study_id>
    <nct_id>NCT03265171</nct_id>
  </id_info>
  <brief_title>A Single-patient Study of Repeat-dose Administration of Prometic Plasminogen (Human) Intravenous</brief_title>
  <official_title>A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prometic Biotherapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana Hemophilia &amp;Thrombosis Center, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Prometic Biotherapeutics, Inc.</source>
  <brief_summary>
    <textblock>
      These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV&#xD;
      infusion in one adult and one child with hypoplasminogenemia. These patients are under&#xD;
      treatment to address wound healing and obstructions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Hypoplasminogenemia</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Plasminogen (Human)</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has provided informed consent.&#xD;
&#xD;
          -  Patient has a diagnosis of compound homozygous Type 1 plasminogen deficiency as&#xD;
             evidence by ligneous conjunctivitis since birth as well as involvement of the&#xD;
             conjunctiva, nasopharynx, gingiva, tracheobronchial tree, gastrointestinal tract, and&#xD;
             urinary tract.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plasminogen</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/NCT03265171
org study id: 2002C013G
nct id: NCT03265171
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV
      infusion in one adult and one child with hypoplasminogenemia. These patients are under
      treatment to address wound healing and obstructions.
expanded access type individual: Yes
intervention type: Biological
intervention name: Plasminogen (Human)
criteria: 
gender: All
minimum age: 16 Months
maximum age: N/A
responsible party type: Sponsor
mesh term: Plasminogen