<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/NCT02221271</url>
  </required_header>
  <id_info>
    <org_study_id>NPB-01-13/C-01</org_study_id>
    <nct_id>NCT02221271</nct_id>
  </id_info>
  <brief_title>Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome</brief_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 Guillain-Barré syndrome were confirmed based on the diagnostic&#xD;
      criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not&#xD;
      conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin)&#xD;
      400mg/kg/day for five consecutive days.&#xD;
&#xD;
      Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.&#xD;
&#xD;
      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse&#xD;
      events by the start of the study treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.</measure>
    <time_frame>Baseline,4weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>days required for 1 grade improvement of the Hughes functional grading scale(FG)</measure>
    <time_frame>Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days required for 2 grade improvement of the Hughes functional grading scale(FG)</measure>
    <time_frame>Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Hughes functional grading scale(FG)</measure>
    <time_frame>Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.</measure>
    <time_frame>Baseline,4weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days required for 1 grade improvement of the Arm Grade(AG)</measure>
    <time_frame>Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days required for 2 grade improvement of the Arm Grade(AG)</measure>
    <time_frame>Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Arm Grade(AG)</measure>
    <time_frame>Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in manual muscle testing(MMT)</measure>
    <time_frame>Baseline,1,2,3,4,8,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in grip strength</measure>
    <time_frame>Baseline,1,2,3,4,8,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in activity of daily living(ADL)</measure>
    <time_frame>Baseline,1,2,3,4,8,12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in electrophysiological findings</measure>
    <time_frame>Baseline,4,12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Guillain-Barré Syndrome</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>NPB-01</intervention_name>
    <arm_group_label>NPB-01</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. In principle, patients are able to receive study drug within 2weeks(with limits of&#xD;
             4weeks) from the start of symptoms.&#xD;
&#xD;
          2. Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4&#xD;
             or grade5(in this regard, if symptoms is progressive, patients with FG is grade3&#xD;
             involve in this study).&#xD;
&#xD;
          3. Patients with plasmapheresis, steroids(in prednisolone equivalent, more than&#xD;
             100mg/day) and immune globulin therapy is no operation for this onset.&#xD;
&#xD;
          4. Patients with greater than or equal to 18 years old at informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with history of shock for NPB-01.&#xD;
&#xD;
          2. Patients with history of hypersensitivity for NPB-01.&#xD;
&#xD;
          3. Patients with history of volatile organic solvent abuse, abnormal porphyrin&#xD;
             metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis,&#xD;
             botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone,&#xD;
             organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to&#xD;
             HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.&#xD;
&#xD;
          4. Patients with malignancy at informed consent.&#xD;
&#xD;
          5. Patients treated with immune globulin at 8 weeks before informed consent.&#xD;
&#xD;
          6. Patients with IgA deficiency.&#xD;
&#xD;
          7. Patients with impaired liver function.&#xD;
&#xD;
          8. Patients with impaired renal function.&#xD;
&#xD;
          9. Patients with cerebro- or cardiovascular disorders.&#xD;
&#xD;
         10. Patients with high risk of thromboembolism.&#xD;
&#xD;
         11. Patients with hemolytic/hemorrhagic anemia.&#xD;
&#xD;
         12. Patients with decreased cardiac function.&#xD;
&#xD;
         13. Patients with decreased platelet.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 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>Guillain-Barre Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02221271
org study id: NPB-01-13/C-01
nct id: NCT02221271
lead sponsor: 
has dmc: No
Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic
      criteria for Guillain-Barré syndrome. 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.

      Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.

      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
      events by the start of the study treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.
time frame: Baseline,4weeks
measure: days required for 1 grade improvement of the Hughes functional grading scale(FG)
time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
measure: days required for 2 grade improvement of the Hughes functional grading scale(FG)
time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
measure: changes in Hughes functional grading scale(FG)
time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
measure: proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.
time frame: Baseline,4weeks
measure: days required for 1 grade improvement of the Arm Grade(AG)
time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
measure: days required for 2 grade improvement of the Arm Grade(AG)
time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
measure: changes in Arm Grade(AG)
time frame: Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks
measure: changes in manual muscle testing(MMT)
time frame: Baseline,1,2,3,4,8,12 weeks
measure: changes in grip strength
time frame: Baseline,1,2,3,4,8,12 weeks
measure: changes in activity of daily living(ADL)
time frame: Baseline,1,2,3,4,8,12 weeks
measure: changes in electrophysiological findings
time frame: Baseline,4,12 weeks
arm group label: NPB-01
arm group type: Experimental
intervention type: Drug
intervention name: NPB-01
arm group label: NPB-01
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Guillain-Barre Syndrome
mesh term: Syndrome