<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/NCT03004209</url>
  </required_header>
  <id_info>
    <org_study_id>1607-120-777</org_study_id>
    <nct_id>NCT03004209</nct_id>
  </id_info>
  <brief_title>Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients</brief_title>
  <official_title>Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis.&#xD;
      Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has&#xD;
      tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and&#xD;
      activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2&#xD;
      and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa&#xD;
      B pathway inhibition regulates pro-inflammatory cytokine production.&#xD;
&#xD;
      We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune&#xD;
      encephalitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">February 6, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 2018</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline modified Rankin Scale (mRS) at 12th week</measure>
    <time_frame>2nd week, 12th week</time_frame>
    <description>Favorable outcome is an improvement of mRS score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse effect</measure>
    <time_frame>2nd week, 4th week, 8th week, 12th week</time_frame>
    <description>Common terminology criteria for adverse events (CTCAE) 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life in Epilepsy Inventory (QOLIE) -31</measure>
    <time_frame>2nd week, 4th week, 8th week, 12th week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination (MMSE)</measure>
    <time_frame>2nd week, 4th week, 8th week, 12th week</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Autoimmune Encephalitis</condition>
  <arm_group>
    <arm_group_label>EPO</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erythropoietin</intervention_name>
    <description>three times per a week 100IU / k</description>
    <arm_group_label>EPO</arm_group_label>
    <other_name>Epokine prefilled injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed autoimmune encephalitis&#xD;
&#xD;
          -  Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g.&#xD;
             Rituximab or cyclophosphamide)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin &gt; 12g/dL&#xD;
&#xD;
          -  Hematochrit &gt;36%&#xD;
&#xD;
          -  Thrombocytosis &gt; 750K&#xD;
&#xD;
          -  AST or ALT &gt; 120&#xD;
&#xD;
          -  HIV (+)&#xD;
&#xD;
          -  Allergic reaction upon erythropoietin&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  mRS before the autoimmune encephalitis &gt; 3&#xD;
&#xD;
          -  Breast feeding or pregnancy&#xD;
&#xD;
          -  History of ischemic stroke or pulmonary thrombosis&#xD;
&#xD;
          -  Refuse to be enrolled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kon Chu, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>September 23, 2021</last_update_submitted>
  <last_update_submitted_qc>September 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Kon Chu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Erythropoietin</keyword>
  <keyword>Autoimmune encephalitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Autoimmune Diseases of the Nervous System</mesh_term>
    <mesh_term>Hashimoto Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03004209
org study id: 1607-120-777
nct id: NCT03004209
lead sponsor: 
has dmc: Yes
This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis.
      Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.
Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has
      tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and
      activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2
      and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa
      B pathway inhibition regulates pro-inflammatory cytokine production.

      We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune
      encephalitis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline modified Rankin Scale (mRS) at 12th week
time frame: 2nd week, 12th week
description: Favorable outcome is an improvement of mRS score.
measure: Adverse effect
time frame: 2nd week, 4th week, 8th week, 12th week
description: Common terminology criteria for adverse events (CTCAE) 4.0
measure: Quality of Life in Epilepsy Inventory (QOLIE) -31
time frame: 2nd week, 4th week, 8th week, 12th week
measure: Mini-Mental State Examination (MMSE)
time frame: 2nd week, 4th week, 8th week, 12th week
arm group label: EPO
arm group type: Other
description: Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection
intervention type: Drug
intervention name: Erythropoietin
description: three times per a week 100IU / k
arm group label: EPO
other name: Epokine prefilled injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Kon Chu, Ph.D
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kon Chu
investigator title: Associate Professor
mesh term: Encephalitis
mesh term: Autoimmune Diseases of the Nervous System
mesh term: Hashimoto Disease
mesh term: Epoetin Alfa
sharing ipd: No