<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/NCT01684462</url>
  </required_header>
  <id_info>
    <org_study_id>AL_IIT_01</org_study_id>
    <nct_id>NCT01684462</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke</brief_title>
  <acronym>ALbumin</acronym>
  <official_title>A Phase IIB Placebo Comparative, Double Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of ALbumin Therapy in Acute Ischemic Stroke Patients in Korea.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Green Cross Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul St. Mary's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the&#xD;
      patients occurred within 12 hours of acute ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the statistics of the cause of death in 2008 by the Statistics Korea, the stroke&#xD;
      was accounted for a large proportion of cause of death among adults, as well as higher&#xD;
      mortality, severe sequelae. These stroke in acute phase showed neurological deterioration&#xD;
      over 50% of the patients after beginning of treatment and the sequelae resulting in that the&#xD;
      nervous tissue was not regenerated is regarded as irreversible changes.&#xD;
&#xD;
      The test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body&#xD;
      weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount of&#xD;
      placebo (saline solution (0.9% normal saline)) administered to the control group will be&#xD;
      compared to evaluate the efficacy and safety of ALbumin for the patients with acute ischemic&#xD;
      stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average change in NIHSS</measure>
    <time_frame>at 14±3days</time_frame>
    <description>Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NIHSS Score</measure>
    <time_frame>at 14±3days</time_frame>
    <description>Comparison of NIHSS score between the control and ALbumin group at 14±3days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with improvement by NIHSS</measure>
    <time_frame>at 14±3days</time_frame>
    <description>Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Scale(mRS) favorable outcome</measure>
    <time_frame>at 3 months</time_frame>
    <description>Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume difference on diffusion MRI</measure>
    <time_frame>at 4 days±1days</time_frame>
    <description>Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent new ischemic lesions on diffusion MRI</measure>
    <time_frame>at 4±1days</time_frame>
    <description>Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Cerebral Infarction</condition>
  <arm_group>
    <arm_group_label>Human Serum Albumin 20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human Serum Albumin 20% 100cc intravenously infused over 4~8h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.9 % Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treatment with same volume of normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Serum Albumin 20</intervention_name>
    <description>Human Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4~8h, commencing within 12 hours of stroke onset</description>
    <arm_group_label>Human Serum Albumin 20</arm_group_label>
    <other_name>Human Serum Albumin Injection 20% 100ml Greencross</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9 % Normal Saline</intervention_name>
    <description>Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset</description>
    <arm_group_label>0.9 % Normal saline</arm_group_label>
    <other_name>0.9 % Normal Saline ChoongWae INJ. 100ml</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age less than 75 years old&#xD;
&#xD;
          -  Patients who can be administered ALbumin within 12hours of onset of acute ischemic&#xD;
             stroke&#xD;
&#xD;
          -  5 ≤ NIHSS score &lt; 15&#xD;
&#xD;
          -  Patients who are agreed by guardian or legal representative in case that patients have&#xD;
             no ability to join study voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of congestive heart failure or patients who are judged congestive&#xD;
             heart failure on admission.&#xD;
&#xD;
          -  Patients with cardiac edema or pulmonary edema.&#xD;
&#xD;
          -  Medical history of myocardial infarction within the past six months.&#xD;
&#xD;
          -  Patients who have serious aortic stenosis and mitral valve stenosis.&#xD;
&#xD;
          -  Signs or symptoms of acute MI on admission (Serum troponin level ≤0.1 ug/L)&#xD;
&#xD;
          -  Those Who had cardiac surgery.&#xD;
&#xD;
          -  Onset of cerebral infarction within the past three months.&#xD;
&#xD;
          -  Before onset of cerebral infarction, patients who were diagnosed as Historical mRS ≥&#xD;
             2.&#xD;
&#xD;
          -  Patients who received treatment of thrombolysis or who planned for treatment of&#xD;
             thrombolysis.&#xD;
&#xD;
          -  Acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission.&#xD;
&#xD;
          -  Acute or chronic lung disease requiring supplemental O2 therapy on admission&#xD;
&#xD;
          -  Severe anemia (Hb &lt; 8.0)&#xD;
&#xD;
          -  Severe dehydration (defined as decreased skin turgor, dry oral mucous membrane,&#xD;
             tachycardia(&gt;100/min), and oliguria)&#xD;
&#xD;
          -  Fever, defined as core body temperature&gt;37.5 ℃&#xD;
&#xD;
          -  Serum creatinine &gt; 2.0 mg/dL&#xD;
&#xD;
          -  History of allergy to albumin.&#xD;
&#xD;
          -  Patients who have side effects of albumin (hyperergia to shock, fever, facial&#xD;
             flushing,urticarial, algor, lumbodynia)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who are in life-threatening or stupor coma situation.&#xD;
&#xD;
          -  Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid&#xD;
             hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on&#xD;
             admission CT or MRI scan.&#xD;
&#xD;
          -  Patients who are not the normal, excesses of circulating blood.&#xD;
&#xD;
          -  Haemolytic anemia, anemia due to blood loss.&#xD;
&#xD;
          -  Immunodeficiency disease, immunosuppression.&#xD;
&#xD;
          -  Blood pressure higher than 180/110 mmHg on admission.&#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_official>
    <last_name>Kwang Soo Lee, M.D, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Vincent's hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Mokdong Hospital</name>
      <address>
        <city>Mok-dong</city>
        <state>Seoul</state>
        <zip>158-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seocho-Gu</city>
        <state>Seoul</state>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeoudo St. Mary's hospital</name>
      <address>
        <city>Yeongdeungpo-Gu</city>
        <state>Seoul</state>
        <zip>150-713</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>November 28, 2013</last_update_submitted>
  <last_update_submitted_qc>November 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Kwang Soo Lee</investigator_full_name>
    <investigator_title>Neurology Professor</investigator_title>
  </responsible_party>
  <keyword>Acute Ischemic Stroke</keyword>
  <keyword>Albumin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT01684462
org study id: AL_IIT_01
nct id: NCT01684462
lead sponsor: 
collaborator: 
has dmc: Yes
In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the
      patients occurred within 12 hours of acute ischemic stroke.
According to the statistics of the cause of death in 2008 by the Statistics Korea, the stroke
      was accounted for a large proportion of cause of death among adults, as well as higher
      mortality, severe sequelae. These stroke in acute phase showed neurological deterioration
      over 50% of the patients after beginning of treatment and the sequelae resulting in that the
      nervous tissue was not regenerated is regarded as irreversible changes.

      The test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body
      weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount of
      placebo (saline solution (0.9% normal saline)) administered to the control group will be
      compared to evaluate the efficacy and safety of ALbumin for the patients with acute ischemic
      stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Average change in NIHSS
time frame: at 14±3days
description: Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days
measure: NIHSS Score
time frame: at 14±3days
description: Comparison of NIHSS score between the control and ALbumin group at 14±3days
measure: Proportion of patients with improvement by NIHSS
time frame: at 14±3days
description: Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.
measure: modified Rankin Scale(mRS) favorable outcome
time frame: at 3 months
description: Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months.
measure: Volume difference on diffusion MRI
time frame: at 4 days±1days
description: Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days
measure: Recurrent new ischemic lesions on diffusion MRI
time frame: at 4±1days
description: Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI
arm group label: Human Serum Albumin 20
arm group type: Experimental
description: Human Serum Albumin 20% 100cc intravenously infused over 4~8h
arm group label: 0.9 % Normal saline
arm group type: Placebo Comparator
description: Treatment with same volume of normal saline
intervention type: Biological
intervention name: Human Serum Albumin 20
description: Human Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4~8h, commencing within 12 hours of stroke onset
arm group label: Human Serum Albumin 20
other name: Human Serum Albumin Injection 20% 100ml Greencross
intervention type: Drug
intervention name: 0.9 % Normal Saline
description: Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset
arm group label: 0.9 % Normal saline
other name: 0.9 % Normal Saline ChoongWae INJ. 100ml
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kwang Soo Lee, M.D, Ph.D
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Kwang Soo Lee
investigator title: Neurology Professor
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Infarction