<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/NCT02209324</url>
  </required_header>
  <id_info>
    <org_study_id>M522101-J12</org_study_id>
    <nct_id>NCT02209324</nct_id>
  </id_info>
  <brief_title>Open-label Study of ASP2151 in Herpes Simplex Patients</brief_title>
  <official_title>Open-label Study of ASP2151 in Herpes Simplex Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maruho Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maruho Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151&#xD;
      in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes&#xD;
      and Kaposi varicelliform).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <primary_completion_date type="Actual">July 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>The proportion of subjects achieving lesion healing by Day 8 of study treatment</measure>
    <time_frame>8 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to healing</measure>
    <time_frame>29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete crusting</measure>
    <time_frame>29 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to virus disappearance</measure>
    <time_frame>29 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Herpes Simplex</condition>
  <arm_group>
    <arm_group_label>ASP2151</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP2151</intervention_name>
    <arm_group_label>ASP2151</arm_group_label>
    <other_name>200 mg once daily</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with a rash associated with herpes simplex and a recurrent episode meeting&#xD;
             the following criteria&#xD;
&#xD;
               -  Recurrent labial/facial herpes: Patients with at least 10 papulae or&#xD;
                  vesicles/pustules&#xD;
&#xD;
               -  Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules&#xD;
                  on the genital organs or in the genital and circumanal region&#xD;
&#xD;
               -  Kaposi varicelliform eruption: Patients with major skin symptoms of papulae or&#xD;
                  vesicles&#xD;
&#xD;
          2. Patients who can start receiving the study drug within 48 hours after onset of rash&#xD;
&#xD;
          3. Age: 16 years or older, but younger than 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are not expected to have an adequate response to oral antiviral&#xD;
             medication.&#xD;
&#xD;
          2. Patients with two or more types of herpes simplex.&#xD;
&#xD;
          3. An extreme decline in immune function&#xD;
&#xD;
          4. Presence of serious complications&#xD;
&#xD;
          5. Patients found to meet any of the following conditions based on laboratory tests&#xD;
             performed within 14 days before informed consent:&#xD;
&#xD;
               -  AST or ALT ≥ 2.5 x upper limit of normal&#xD;
&#xD;
               -  Platelet count &lt; lower limit of normal&#xD;
&#xD;
               -  Serum creatinine ≥ 1.5 mg/dL&#xD;
&#xD;
               -  Creatinine clearance &lt; 30 mL/min&#xD;
&#xD;
          6. Current or previous history of malignant tumor within 5 years before informed consent&#xD;
&#xD;
          7. Diagnosis of autoimmune disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sapporo Hokkaido Japan</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oota-ku Tokyo Japan</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama Kanagawa Japan</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>March 15, 2016</last_update_submitted>
  <last_update_submitted_qc>March 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 16, 2016</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>Herpes Simplex</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/NCT02209324
org study id: M522101-J12
nct id: NCT02209324
lead sponsor: 
has dmc: Yes
A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151
      in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes
      and Kaposi varicelliform).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The proportion of subjects achieving lesion healing by Day 8 of study treatment
time frame: 8 days
measure: Time to healing
time frame: 29 days
measure: Time to complete crusting
time frame: 29 days
measure: Time to virus disappearance
time frame: 29 days
arm group label: ASP2151
arm group type: Experimental
intervention type: Drug
intervention name: ASP2151
arm group label: ASP2151
other name: 200 mg once daily
criteria: 
gender: All
minimum age: 16 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Herpes Simplex