<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/NCT03237728</url>
  </required_header>
  <id_info>
    <org_study_id>HR-KB104</org_study_id>
    <nct_id>NCT03237728</nct_id>
  </id_info>
  <brief_title>Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients</brief_title>
  <official_title>Randomized, Double-blind Placebo-controlled Clinical Study to Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of Multiple-dose Kukoamine B Mesilate in Sepsis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Chasesun Pharmaceutical Co., LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Chasesun Pharmaceutical Co., LTD</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>
      Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B&#xD;
      Mesilate in Sepsis Patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Actual">September 25, 2019</completion_date>
  <primary_completion_date type="Actual">September 25, 2019</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Day-1 to Day8</time_frame>
    <description>AE, physical examination, monitoring of vital signs, Laboratory examination etc.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>0.06mg/kg,KB and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A:0.06mg/kg,Q8h,Day1-Day7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.12mg/kg,KB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B:0.12mg/kg,Q8h,Day1-Day7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.24mg/kg,KB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group C:0.24mg/kg,Q8h,Day1-Day7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebos</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group D:Placebos,Q8h,Day1-Day7</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.06mg/kg,KB</intervention_name>
    <description>0.06mg/kg,Q8h,Day1-Day7</description>
    <arm_group_label>0.06mg/kg,KB and Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.12mg/kg,KB</intervention_name>
    <description>0.12mg/kg,Q8h,Day1-Day7</description>
    <arm_group_label>0.12mg/kg,KB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.24mg/,KB</intervention_name>
    <description>0.24mg/kg,Q8h,Day1-Day7</description>
    <arm_group_label>0.24mg/kg,KB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebos,Q8h,Day1-Day7</description>
    <arm_group_label>0.06mg/kg,KB and Placebo</arm_group_label>
    <arm_group_label>Placebos</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The age of ≥ 18 years of age and ≤ 70 years of age, gender is not limited;&#xD;
&#xD;
          2. Confirmed or suspected bacterial infection (refer to Appendix 5);&#xD;
&#xD;
          3. Infection-related organ failure does not exceed 24 hours; organ failure is defined as&#xD;
             circulation, (SOFA) ≥ 3 points in at least one organ or system of the respiratory,&#xD;
             kidney, liver, coagulation and central nervous system;&#xD;
&#xD;
          4. The time interval between the selection of the test drug and the test drug is not more&#xD;
             than 8 hours;&#xD;
&#xD;
          5. Infertility test for women of childbearing age;&#xD;
&#xD;
          6. Childbearing age within six months without child care plan and agreed to take&#xD;
             effective measures during the study of contraception;&#xD;
&#xD;
          7. Patients or legal representatives signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women, or unable to take effective measures of contraception;&#xD;
&#xD;
          2. Patients are expected to live less than 28 days due to basic diseases, such as poor&#xD;
             control of malignant tumor, cardiac arrest in 30 days, and end-stage lung disease.&#xD;
&#xD;
          3. The patient has the following chronic organ dysfunction or immunosuppression (based on&#xD;
             the chronic health scoring assessment of the APACHE II score) : a) heart: New York&#xD;
             heart association cardiac function IV; B) breathing: chronic obstructive, obstructive,&#xD;
             or vascular lung disease can lead to severe restrictions on activities, i.e. the&#xD;
             inability to go upstairs or to do housework; Or clear chronic hypoxia, CO2 retention,&#xD;
             secondary real erythrocyte, severe pulmonary hypertension (&gt; 40 mmHg) or respiratory&#xD;
             muscle dependence; C) kidneys: receiving long-term dialysis; D) liver: liver cirrhosis&#xD;
             confirmed by biopsy and clear portal hypertension; The upper digestive tract&#xD;
             hemorrhage caused by portal hypertension; Or previous liver failure/hepatic&#xD;
             encephalopathy/hepatic coma; E) of immune function: accept the treatment of impact&#xD;
             resistance to infection, such as immune suppression therapy, chemotherapy, radiation&#xD;
             therapy, or for a long time the recent use of high doses of hormones), or sickness&#xD;
             impact resistance to infection, such as leukemia, lymphoma and AIDS);&#xD;
&#xD;
          4. Solid organ or bone marrow transplantation;&#xD;
&#xD;
          5. Plant survival status;&#xD;
&#xD;
          6. The following conditions occurred within 4 weeks prior to infection: a) acute&#xD;
             pulmonary embolism; B) transfusion response; C) acute coronary syndrome;&#xD;
&#xD;
          7. Confirmed or highly suspected of acute infectious diseases such as viral hepatitis&#xD;
             activity and active tuberculosis;&#xD;
&#xD;
          8. Patients with sinus bradycardia (less than 60 per minute);&#xD;
&#xD;
          9. Severe anemia (hemoglobin &lt; 7.0 g/dL);&#xD;
&#xD;
         10. Uncontrolled bleeding in the past 24 hours;&#xD;
&#xD;
         11. Large area burns or chemical burns (III degree burns area &gt; 30% BSA);&#xD;
&#xD;
         12. The average arterial pressure was &lt; 65 mmHg after adequate liquid resuscitation and&#xD;
             vasoactive drug therapy.&#xD;
&#xD;
         13. Acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (ANC &lt;&#xD;
             500 / mm3), or severe thrombocytopenia (&lt; 20,000 / mm3);&#xD;
&#xD;
         14. Allergic to the active ingredient or its auxiliary materials;&#xD;
&#xD;
         15. The medication patients are using may severely affect the metabolism of the drug;&#xD;
&#xD;
         16. Patients and (or) legal representatives have signed an unresuscitation (DNR), or&#xD;
             decided to withdraw life support (withdraw) or restrict life support for the intensity&#xD;
             (of the patient) and sign the informed consent form;&#xD;
&#xD;
         17. Participated in clinical intervention test in 3 months;&#xD;
&#xD;
         18. The subject is a researcher or his immediate family member, or may have improper&#xD;
             informed consent;&#xD;
&#xD;
         19. The attending physician considers it inappropriate for the patient to participate in&#xD;
             this test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>January 19, 2020</last_update_submitted>
  <last_update_submitted_qc>January 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</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>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03237728
org study id: HR-KB104
nct id: NCT03237728
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients
To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B
      Mesilate in Sepsis Patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Incidence of adverse events
time frame: Day-1 to Day8
description: AE, physical examination, monitoring of vital signs, Laboratory examination etc.
arm group label: 0.06mg/kg,KB and Placebo
arm group type: Experimental
description: Group A:0.06mg/kg,Q8h,Day1-Day7
arm group label: 0.12mg/kg,KB
arm group type: Experimental
description: Group B:0.12mg/kg,Q8h,Day1-Day7
arm group label: 0.24mg/kg,KB
arm group type: Experimental
description: Group C:0.24mg/kg,Q8h,Day1-Day7
arm group label: Placebos
arm group type: Experimental
description: Group D:Placebos,Q8h,Day1-Day7
intervention type: Drug
intervention name: 0.06mg/kg,KB
description: 0.06mg/kg,Q8h,Day1-Day7
arm group label: 0.06mg/kg,KB and Placebo
intervention type: Drug
intervention name: 0.12mg/kg,KB
description: 0.12mg/kg,Q8h,Day1-Day7
arm group label: 0.12mg/kg,KB
intervention type: Drug
intervention name: 0.24mg/,KB
description: 0.24mg/kg,Q8h,Day1-Day7
arm group label: 0.24mg/kg,KB
intervention type: Drug
intervention name: Placebos
description: Placebos,Q8h,Day1-Day7
arm group label: 0.06mg/kg,KB and Placebo
arm group label: Placebos
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: Undecided