<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/NCT02204930</url>
  </required_header>
  <id_info>
    <org_study_id>HX-01-UK</org_study_id>
    <secondary_id>2013-001993-10</secondary_id>
    <nct_id>NCT02204930</nct_id>
  </id_info>
  <brief_title>PeproStat Haemostat Study in Subjects Undergoing Liver Surgery</brief_title>
  <official_title>A Multi-centre, Open-label, Uncontrolled, First-in-Human Study to Evaluate the Safety and Tolerability and Explore the Efficacy of PeproStat in Gelita-Spon® Gelatin Sponge in Subjects Undergoing Open Liver Resection Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haemostatix Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haemostatix Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this First in Man study is to evaluate the safety and tolerability, as well as&#xD;
      to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in&#xD;
      patients undergoing open liver resection surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of PeproStat</measure>
    <time_frame>within 30 days after surgery and study treatment</time_frame>
    <description>Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>Percentages of subjects who achieve haemostasis within 3, 5, 7 and 10 minutes following application for the first five subjects and at 1, 3, 5, 7 &amp; 10 minutes following application in subsequent subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>Mean time to haemostasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>Percentage of subjects who do not achieve haemostasis within 10 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>Administered dose of PeproStat determined by number of sponges administered to a single bleeding site.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Immunogenicity</measure>
    <time_frame>within 30 days after surgery and study treatment</time_frame>
    <description>Immunogenicity to be investigated using a specific antibody test which has been established but not yet validated.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Haemostat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PeproStat</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PeproStat</intervention_name>
    <description>A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.</description>
    <arm_group_label>Haemostat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are able and willing to provide written informed consent to participate in this study,&#xD;
             confirmed by signing the informed consent documents&#xD;
&#xD;
          -  Adult males and females ≥18 years of age&#xD;
&#xD;
          -  Female subjects must be post-menopausal. Post-menopausal status is defined as any of&#xD;
             the following: natural menopause with menses &gt;1 year ago; radiation induced&#xD;
             oophorectomy with last menses &gt;1 year ago; chemotherapy induced menopause with 1 year&#xD;
             interval since last menses&#xD;
&#xD;
          -  Willing and able to comply with all protocol requirements including follow-up&#xD;
&#xD;
          -  Subject must have a haemoglobin ≥ 9.0 g/dL at screening&#xD;
&#xD;
          -  Subject must have a platelet count ≥ 100,000/mm3 at screening&#xD;
&#xD;
          -  Subject is undergoing a planned open liver resection&#xD;
&#xD;
          -  Male subjects must be willing and able to use adequate contraception from enrollment&#xD;
             through to the 30 day follow-up visit&#xD;
&#xD;
          -  During the surgery, the subject presents an identified target bleeding site (TBS) with&#xD;
             oozing, mild or moderate bleeding, which conventional surgical techniques are&#xD;
             insufficient to control and would otherwise be a candidate for standard haemostats&#xD;
&#xD;
          -  During the surgery, subject presents no intraoperative complications, other than&#xD;
             bleeding, that may interfere with study assessments as judged by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is undergoing emergency surgical procedure&#xD;
&#xD;
          -  Recipient of a liver transplant&#xD;
&#xD;
          -  Females of child-bearing potential&#xD;
&#xD;
          -  Active infection at the time of the liver resection&#xD;
&#xD;
          -  International Normalized Ratio (INR) &gt; 2.0 or APTT ratio &gt; 2.0 at screening&#xD;
&#xD;
          -  Fibrinogen level &lt; 1.5g/L at screening&#xD;
&#xD;
          -  History of thromboembolic disease and/or thrombophilia&#xD;
&#xD;
          -  Any other disease or condition that may affect normal blood clotting, for example&#xD;
             thrombocytopenia, as judged by the investigator&#xD;
&#xD;
          -  A known history of anaphylaxis or allergic reaction to human albumin, PEGylated&#xD;
             proteins, yeast or moulds, porcine products or other components in the IMP&#xD;
&#xD;
          -  Participation in another investigational drug or device research study within 30 days&#xD;
             before and after enrolment in the current study&#xD;
&#xD;
          -  Current known or suspected alcohol and/or drug abuse or dependence at the time of&#xD;
             screening&#xD;
&#xD;
          -  Any concurrent medical, surgical, or psychiatric condition that may, in the&#xD;
             investigator's opinion, affect the subject's willingness or ability to meet all study&#xD;
             requirements during the study duration&#xD;
&#xD;
          -  During the surgery, subject presents severe bleeding where use of a topical haemostat&#xD;
             would be inappropriate&#xD;
&#xD;
          -  Subject is taking any prohibited medications&#xD;
&#xD;
          -  BMI at screening of ≥35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>D Mirza, MBBS, MS, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Queen Elizabeth Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's University Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings University Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>October 20, 2015</last_update_submitted>
  <last_update_submitted_qc>October 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Haemostat</keyword>
  <keyword>Liver surgery</keyword>
  <keyword>Primary liver cancer</keyword>
  <keyword>Metastatic liver cancer</keyword>
  <keyword>Benign liver disease such as adenoma</keyword>
  <keyword>Hepatitis-related or alcoholic-related liver cirrhosis</keyword>
  <keyword>Living donation for liver transplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</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/NCT02204930
org study id: HX-01-UK
secondary id: 2013-001993-10
nct id: NCT02204930
lead sponsor: 
has dmc: No
The purpose of this First in Man study is to evaluate the safety and tolerability, as well as
      to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in
      patients undergoing open liver resection surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Safety of PeproStat
time frame: within 30 days after surgery and study treatment
description: Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
time frame: During surgery
description: Percentages of subjects who achieve haemostasis within 3, 5, 7 and 10 minutes following application for the first five subjects and at 1, 3, 5, 7 & 10 minutes following application in subsequent subjects.
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
time frame: During surgery
description: Mean time to haemostasis.
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
time frame: During surgery
description: Percentage of subjects who do not achieve haemostasis within 10 minutes.
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
time frame: During surgery
description: Administered dose of PeproStat determined by number of sponges administered to a single bleeding site.
measure: Exploratory Immunogenicity
time frame: within 30 days after surgery and study treatment
description: Immunogenicity to be investigated using a specific antibody test which has been established but not yet validated.
arm group label: Haemostat
arm group type: Experimental
description: PeproStat
intervention type: Drug
intervention name: PeproStat
description: A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.
arm group label: Haemostat
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: D Mirza, MBBS, MS, FRCS
role: Principal Investigator
affiliation: The Queen Elizabeth Hospital
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hemorrhage