xml: <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/NCT06035861</url>
    </required_header>
    <id_info>
      <org_study_id>22HH7807</org_study_id>
      <nct_id>NCT06035861</nct_id>
    </id_info>
    <brief_title>Endothelial Cell Activation and Total Pulmonary Resistance in PAH</brief_title>
    <official_title>Investigating the Relationship Between Endothelial Cell Activation and Total Pulmonary Resistance in Pulmonary Artery Hypertension (PAH)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To determine whether changes in endothelial cell dysfunction are associated with changes in&#xD;
        total pulmonary resistance in patients with pulmonary arterial hypertension&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with PAH will be exposed to XBD173. Markers of endothelial cell dysfunction and&#xD;
        activation will be measured in the plasma, and changes in total pulmonary resistance will be&#xD;
        meausured with an implantable monitor&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage change in plasma sVCAM1, e-selectin, GDF-15 and NT-proBNP</measure>
      <time_frame>8 weeks</time_frame>
      <description>Percentage change in plasma markers</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage change in total pulmonary resistance</measure>
      <time_frame>8 weeks</time_frame>
      <description>Percentage change in total pulmonary resistance</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Pulmonary Artery Hypertension</condition>
    <arm_group>
      <arm_group_label>XBD173</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8 weeks exposure to XBD173</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>XBD173</intervention_name>
      <description>Participants will be treated with XBD173 90mg, once or twice daily, for 8 weeks</description>
      <arm_group_label>XBD173</arm_group_label>
      <other_name>AC5216</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects aged between 18-75 years old&#xD;
  &#xD;
            2. PAH which is: idiopathic; PAH heritable; PAH associated with connective tissue&#xD;
               disease; PAH after ≥ 1 year repair of congenital systemic to pulmonary shunt; or PAH&#xD;
               associated with anorexignes or other drugs.&#xD;
  &#xD;
            3. Resting mean pulmonary artery pressure ≥25 mmHg, pulmonary capillary wedge pressure&#xD;
               ≤15 mmHg, PVR &gt;5 wood units, and normal or reduced cardiac output, as measured by a&#xD;
               previous right heart catheterisation (RHC).&#xD;
  &#xD;
            4. Have an insertable FDA/CE cardiac rhythm monitor and pulmonary artery pressure monitor&#xD;
               that captures cardiopulmonary haemodynamics and daily activity.&#xD;
  &#xD;
            5. Six-minute walking distance &gt;50m at entry&#xD;
  &#xD;
            6. Stable on an unchanged PAH therapeutic regime comprising at least 2 therapies licensed&#xD;
               for PAH (any combination of endothelin receptor antagonist, phosphodiesterase&#xD;
               inhibitor or prostacyclin analogue) for at least 1 month prior to screening&#xD;
  &#xD;
            7. Subjects willing to be genotyped for genes that influence XBD173 activity&#xD;
  &#xD;
            8. Able to provide written informed consent prior to any study mandated procedures&#xD;
  &#xD;
            9. Contraception: Fertile females (women of childbearing potential) are eligible to&#xD;
               participate after a negative highly sensitive pregnancy test, if they are taking a&#xD;
               highly effective method of contraception other than the oral contraceptive pill during&#xD;
               treatment and until the end of relevant systemic exposure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unable to provide informed consent and/or are non-fluent speakers of the English&#xD;
               language&#xD;
  &#xD;
            2. Hypersensitivity to XBD173 or to any of the excipients&#xD;
  &#xD;
            3. Clinically-significant renal disease (confirmed by creatinine clearance &lt;30 ml/min per&#xD;
               1.73m2)&#xD;
  &#xD;
            4. Clinically-significant liver disease (confirmed by serum transaminases &gt;2 times than&#xD;
               upper normal limit)&#xD;
  &#xD;
            5. Anaemia confirmed by haemoglobin concentration &lt;10 g/dl&#xD;
  &#xD;
            6. Individuals known to have haemoglobinopathy sickle cell disease, thalassaemia&#xD;
  &#xD;
            7. Hospital admission related to PAH or change in PAH therapy within 3 months prior to&#xD;
               screening&#xD;
  &#xD;
            8. History of left-sided heart disease and/or clinically significant cardiac disease,&#xD;
               including but not limited to any of the following:&#xD;
  &#xD;
                 1. Aortic or mitral valve disease (stenosis or regurgitation) defined as greater&#xD;
                    than mild aortic insufficiency, mild aortic stenosis, mild mitral stenosis,&#xD;
                    moderate mitral regurgitation&#xD;
  &#xD;
                 2. Mechanical or bioprosthetic cardiac valve&#xD;
  &#xD;
                 3. Pericardial constriction, effusion with tamponade physiology, or abnormal left&#xD;
                    atrial size.&#xD;
  &#xD;
                 4. Restrictive or congestive cardiomyopathy&#xD;
  &#xD;
                 5. Left ventricular ejection fraction ≤50% (measured in echocardiogram at screening)&#xD;
  &#xD;
                 6. Symptomatic coronary disease&#xD;
  &#xD;
                 7. Significant (2+ for regurgitation) valvular disease other than tricuspid or&#xD;
                    pulmonary regurgitation&#xD;
  &#xD;
                 8. Acutely decompensated left heart failure within 1 month of screening&#xD;
  &#xD;
                 9. History of untreated obstructive sleep apnoea&#xD;
  &#xD;
            9. Evidence of significant lung disease on high-resolution CT (if available) or recent&#xD;
               (performed within 12 months) lung function, where FEV1 &lt; 50% predicted and FVC &lt; 70%&#xD;
               predicted, and DLCO (or TLCO) &lt; 50% predicted if any CT abnormalities; judged by the&#xD;
               Site Physician&#xD;
  &#xD;
           10. Patients with a history of uncontrolled systemic hypertension&#xD;
  &#xD;
           11. Acute infection (including eye, dental, and skin infections)&#xD;
  &#xD;
           12. Chronic inflammatory disease including HIV, and Hepatitis B&#xD;
  &#xD;
           13. Women of childbearing potential who are pregnant or breastfeeding (if applicable)&#xD;
  &#xD;
           14. Patients who have received an Investigational Medicinal Product (IMP) within 5&#xD;
               half-lives of the last dose of the IMP or 1 month (which ever is greater) before the&#xD;
               baseline visit&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Pulmonary Arterial Hypertension</mesh_term>
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>December 5, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT06035861/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035861
  org study id: 22HH7807
  nct id: NCT06035861
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To determine whether changes in endothelial cell dysfunction are associated with changes in
        total pulmonary resistance in patients with pulmonary arterial hypertension
  Patients with PAH will be exposed to XBD173. Markers of endothelial cell dysfunction and
        activation will be measured in the plasma, and changes in total pulmonary resistance will be
        meausured with an implantable monitor
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Percentage change in plasma sVCAM1, e-selectin, GDF-15 and NT-proBNP
  time frame: 8 weeks
  description: Percentage change in plasma markers
  measure: Percentage change in total pulmonary resistance
  time frame: 8 weeks
  description: Percentage change in total pulmonary resistance
  arm group label: XBD173
  arm group type: Experimental
  description: 8 weeks exposure to XBD173
  intervention type: Drug
  intervention name: XBD173
  description: Participants will be treated with XBD173 90mg, once or twice daily, for 8 weeks
  arm group label: XBD173
  other name: AC5216
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Pulmonary Arterial Hypertension
  mesh term: Hypertension
  sharing ipd: No
  provided document: 