<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/NCT01696500</url>
  </required_header>
  <id_info>
    <org_study_id>NPB-01-07/C-01</org_study_id>
    <nct_id>NCT01696500</nct_id>
  </id_info>
  <brief_title>Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.</brief_title>
  <official_title>NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nihon Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nihon Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were&#xD;
      confirmed based on the investigators national diagnostic criteria. Patients who meet all&#xD;
      inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01&#xD;
      (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy&#xD;
      of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be&#xD;
      evaluated the disease evaluation score et al.&#xD;
&#xD;
      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse&#xD;
      events by 20 days after the start of the study treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 3</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>disease evaluation score</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>disease evaluation score</measure>
    <time_frame>4 ,10 ,20 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>avulsed skin area</measure>
    <time_frame>20 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>erythematous area</measure>
    <time_frame>20 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Stevens-Johnson Syndrome</condition>
  <condition>Toxic Epidermal Necrolysis</condition>
  <arm_group>
    <arm_group_label>NPB-01</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous immunoglobulin</intervention_name>
    <arm_group_label>NPB-01</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who the disease evaluation score is more than 14 at study medication&#xD;
             received.&#xD;
&#xD;
          2. Patients with corticosteroids over 20mg/day(Prednisolone) at study medication received&#xD;
             and continued this treatment more than 2 days.&#xD;
&#xD;
          3. Patients with treatment effect is insufficiency before study medication received and&#xD;
             need additional treatment.&#xD;
&#xD;
          4. Patients aged more than twenty years old at informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who the SCORTEN score is more than 4 at study medication received.&#xD;
&#xD;
          2. Patients with multiple organ failure at study medication received.&#xD;
&#xD;
          3. Patients with severe respiratory disorder at study medication received.&#xD;
&#xD;
          4. Patients with Drug-induced hypersensitivity syndrome (DIHS) at informed consent.&#xD;
&#xD;
          5. Patients with malignancy during treatment at informed consent.&#xD;
&#xD;
          6. Patients treated with corticosteroids dosage is change at 2 days before study&#xD;
             medication received.&#xD;
&#xD;
          7. Patients treated with corticosteroids pulse therapy(including semi-pulse therapy) at 2&#xD;
             days before study medication received.&#xD;
&#xD;
          8. Patients treated with plasmapheresis at 2 days before study medication received.&#xD;
&#xD;
          9. Patients treated with high-dose intravenous immunoglobulin at 28 days before informed&#xD;
             consent.&#xD;
&#xD;
         10. Patients with history of shock or hypersensitivity for NPB-01.&#xD;
&#xD;
         11. Patients with IgA deficiency.&#xD;
&#xD;
         12. Patients with severe impaired liver function diagnosed virus hepatitis or cirrhosis et&#xD;
             al.&#xD;
&#xD;
         13. Patients with more than 2mg/dL serum creatinine.&#xD;
&#xD;
         14. Patients with severe cerebro- or cardiovascular disorders.&#xD;
&#xD;
         15. Patients with high risk of thromboembolism.&#xD;
&#xD;
         16. Patients with hemolytic/hemorrhagic anemia.&#xD;
&#xD;
         17. Patients with severe decreased cardiac function.&#xD;
&#xD;
         18. Patients with decreased platelet less than 75,000/μL..&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nihon Pharmaceutical Co., Ltd</name>
      <address>
        <city>Tokyo</city>
        <zip>101-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>July 1, 2014</last_update_submitted>
  <last_update_submitted_qc>July 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVIG in Stevens-Johnson syndrome</keyword>
  <keyword>Toxic Epidermal Necrolysis</keyword>
  <keyword>Patients with Stevens-Johnson syndrome</keyword>
  <keyword>Toxic Epidermal Necrolysis unresponsive to corticosteroids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stevens-Johnson Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>gamma-Globulins</mesh_term>
    <mesh_term>Rho(D) Immune Globulin</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/NCT01696500
org study id: NPB-01-07/C-01
nct id: NCT01696500
lead sponsor: 
has dmc: No
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were
      confirmed based on the investigators national diagnostic criteria. Patients who meet all
      inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01
      (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, efficacy
      of NPB-01 for therapy of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis will be
      evaluated the disease evaluation score et al.

      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
      events by 20 days after the start of the study treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: disease evaluation score
time frame: 7 days
measure: disease evaluation score
time frame: 4 ,10 ,20 days
measure: avulsed skin area
time frame: 20 days
measure: erythematous area
time frame: 20 days
arm group label: NPB-01
arm group type: Experimental
intervention type: Drug
intervention name: Intravenous immunoglobulin
arm group label: NPB-01
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Stevens-Johnson Syndrome
mesh term: Syndrome
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
mesh term: gamma-Globulins
mesh term: Rho(D) Immune Globulin