<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/NCT03270735</url>
  </required_header>
  <id_info>
    <org_study_id>2016-ZK-003</org_study_id>
    <nct_id>NCT03270735</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection</brief_title>
  <official_title>A Multi-centre, Randomised, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Snake Venom Thrombin Injection in the Treatment of Moderate to Severe Hemoptysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lee's Pharmaceutical Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhaoke Pharmaceutical (Hefei) Company Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lee's Pharmaceutical Limited</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-centre, randomised, double blind, placebo controlled clinical study which is&#xD;
      designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to&#xD;
      severe hemoptysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AEs and SAEs</measure>
    <time_frame>7 days</time_frame>
    <description>The incidence of AEs and SAEs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effective rate of treating hemoptysis</measure>
    <time_frame>72 hours</time_frame>
    <description>Effective rate of treating hemoptysis 72 hours after administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hemoptysis</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Snake venom thrombin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Snake venom thrombin simulant</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Snake venom thrombin (Treatment)</intervention_name>
    <description>Snake venom thrombin</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Snake venom thrombin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>No snake venom thrombin</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Snake venom thrombin simulant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-75 years;&#xD;
&#xD;
          -  Hemoptysis &gt;=100 mL within 24 hours;&#xD;
&#xD;
          -  Bronchiectasis diagnosed by chest high resolution CT;&#xD;
&#xD;
          -  Patient, family or guardian is willing to sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With severe hepatic or renal insufficiency, ALT&gt;3 ULN, creatinine clearance &lt;30 mL/min&#xD;
             or serum creatinine ≥200 µmol/L or ≥2.5 mg/dL;&#xD;
&#xD;
          -  Uncontrollable hypertension (SBP&gt;180mmHg or DBP&gt;110mmHg) or hypotension shock (SBP&lt;90&#xD;
             mmHg) at randomization;&#xD;
&#xD;
          -  History of thrombosis, patients who have undergone thrombosis, or who have severe&#xD;
             hematologic diseases;&#xD;
&#xD;
          -  Patient with bleeding caused by DIC or vascular disease;&#xD;
&#xD;
          -  Patient with coagulation dysfunction&#xD;
&#xD;
               1. INR&gt;2&#xD;
&#xD;
               2. Patient with abnormal coagulation function or other bleeding disease (including&#xD;
                  clinical congenital bleeding disorders, such as von Willebrand disease or&#xD;
                  acquired hemophilia; hemorrhagic disease; and significant unexplained hemorrhagic&#xD;
                  disease)&#xD;
&#xD;
               3. Platelet count &lt;100×109 /L;&#xD;
&#xD;
          -  known allergic to aspirin, clopidogrel, heparin, snake venom blood clotting enzyme, or&#xD;
             any component in the study drug allergy or allergic constitution;&#xD;
&#xD;
          -  Women who are pregnant or lactating and women of child-bearing agewho do not take&#xD;
             reliable contraceptive measures;&#xD;
&#xD;
          -  Patients who are or are planning to participate in other clinical trials during the&#xD;
             study period;&#xD;
&#xD;
          -  Within 72 hours before using the following products including Hemocoagulase For&#xD;
             Injection (邦亭®), injection spearhead haemocoagulase (巴曲亭®), Haemocoagulase Agkistrodon&#xD;
             for Injection (苏灵®), Hemocoagulase Atrox for Injection (立止血®), leaf pigment or other&#xD;
             hemostatic agents;&#xD;
&#xD;
          -  Life expectancy of less than 3 months;&#xD;
&#xD;
          -  Any other patients who have been judged unfit to participate in this clinical study,&#xD;
             including those who are unable or unwilling to comply with the protocol requirements;&#xD;
&#xD;
          -  Patients who had participated in other clinical studies within three months prior to&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nan Yang, MD, PhD</last_name>
    <phone>852-23146533</phone>
    <email>nancy.yang@leespharm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fuwai Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuhui Zhang, MD</last_name>
      <phone>86-10-88322674</phone>
      <email>yuhuizhangjoy@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>June 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</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>Hemoptysis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombin</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/NCT03270735
org study id: 2016-ZK-003
nct id: NCT03270735
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a multi-centre, randomised, double blind, placebo controlled clinical study which is
      designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to
      severe hemoptysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: AEs and SAEs
time frame: 7 days
description: The incidence of AEs and SAEs
measure: Effective rate of treating hemoptysis
time frame: 72 hours
description: Effective rate of treating hemoptysis 72 hours after administration
arm group label: Treatment
arm group type: Experimental
description: Snake venom thrombin
arm group label: Placebo
arm group type: Placebo Comparator
description: Snake venom thrombin simulant
intervention type: Drug
intervention name: Snake venom thrombin (Treatment)
description: Snake venom thrombin
arm group label: Treatment
other name: Snake venom thrombin
intervention type: Drug
intervention name: Placebo
description: No snake venom thrombin
arm group label: Placebo
other name: Snake venom thrombin simulant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nan Yang, MD, PhD
phone: 852-23146533
email: nancy.yang@leespharm.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Hemoptysis
mesh term: Thrombin