<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/NCT03245528</url>
  </required_header>
  <id_info>
    <org_study_id>LJ501-EAP01</org_study_id>
    <nct_id>NCT03245528</nct_id>
  </id_info>
  <brief_title>Expanded Access for LJPC-501</brief_title>
  <official_title>Expanded Access for LJPC-501</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>La Jolla Pharmaceutical Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>La Jolla Pharmaceutical Company</source>
  <brief_summary>
    <textblock>
      The primary objective of the study is to provide access to LJPC-501 for distributive shock&#xD;
      patients who remain hypotensive despite receiving fluid and vasopressor therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective&#xD;
&#xD;
      The primary objective of the study is to provide access to LJPC-501 for distributive shock&#xD;
      patients who remain hypotensive despite receiving fluid and vasopressor therapy.&#xD;
&#xD;
      Secondary Objective&#xD;
&#xD;
      The secondary objective of the study is to assess the safety of LJPC-501.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Catecholamine Resistant Hypotension (CRH)</condition>
  <condition>Distributive Shock</condition>
  <condition>High Output Shock</condition>
  <condition>Sepsis</condition>
  <condition>Vasodilatory Shock</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LJPC-501</intervention_name>
    <description>angiotensin II</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy&#xD;
             and vasopressor therapy and who received or are receiving a total sum norepinephrine&#xD;
             (NE) equivalent unit dose of &gt; 0.2 µg/kg/min for at least 2 hours prior to LJPC-501&#xD;
             infusion.&#xD;
&#xD;
          -  Patients must have central venous access and an arterial line present, which is&#xD;
             expected to remain for the duration of the LJPC-501 infusion.&#xD;
&#xD;
          -  Patients must be adequately volume resuscitated in the opinion of the treating&#xD;
             investigator.&#xD;
&#xD;
          -  Patients must have clinical features of distributive shock documented by either&#xD;
             estimated or measured CI &gt; 2.3 L/min/m^2 determined by echocardiogram or another&#xD;
             cardiac output monitoring modality OR a concurrent CVP &gt; 8 mmHg and ScvO2 &gt; 70%.&#xD;
&#xD;
          -  Patient or legal surrogate is willing and able to provide informed consent per local&#xD;
             guidance and patient/legal surrogate is willing to comply with all protocol&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a MAP &gt; 80 mmHg.&#xD;
&#xD;
          -  Patients diagnosed with acute occlusive coronary syndrome requiring intervention.&#xD;
&#xD;
          -  Patients who have been on ECMO &lt; 6 hours.&#xD;
&#xD;
          -  Patients in liver failure with a MELD score ≥ 30.&#xD;
&#xD;
          -  Patients not mechanically ventilated with a history of asthma or who are currently&#xD;
             experiencing bronchospasm requiring the use of inhaled bronchodilators.&#xD;
&#xD;
          -  Patients with acute mesenteric ischemic or history of mesenteric ischemia.&#xD;
&#xD;
          -  Patients with Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.&#xD;
&#xD;
          -  Patients with an expected lifespan of &lt; 24 hours.&#xD;
&#xD;
          -  Patients with active bleeding AND an anticipated need for transfusion of &gt; 4 units&#xD;
             PRBCs within 48 hours of the initiation of LJPC-501.&#xD;
&#xD;
          -  Patients with active bleeding AND hemoglobin &lt; 7 g/dL.&#xD;
&#xD;
          -  Patients with an ANC &lt; 500 cells/mm^3.&#xD;
&#xD;
          -  Patients with a known allergy to mannitol.&#xD;
&#xD;
          -  Patients who are currently participating in an investigational interventional trial.&#xD;
&#xD;
          -  Women who are known to be pregnant at the time of Screening or have a positive serum&#xD;
             or urine β-hCG, if of childbearing potential.&#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>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2018</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>Hypotension</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angiotensin II</mesh_term>
    <mesh_term>Giapreza</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/NCT03245528
org study id: LJ501-EAP01
nct id: NCT03245528
lead sponsor: 
The primary objective of the study is to provide access to LJPC-501 for distributive shock
      patients who remain hypotensive despite receiving fluid and vasopressor therapy.
Primary Objective

      The primary objective of the study is to provide access to LJPC-501 for distributive shock
      patients who remain hypotensive despite receiving fluid and vasopressor therapy.

      Secondary Objective

      The secondary objective of the study is to assess the safety of LJPC-501.
expanded access type treatment: Yes
intervention type: Drug
intervention name: LJPC-501
description: angiotensin II
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Sponsor
mesh term: Hypotension
mesh term: Shock
mesh term: Angiotensin II
mesh term: Giapreza