<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/NCT03266601</url>
  </required_header>
  <id_info>
    <org_study_id>AFL-2015-2.0</org_study_id>
    <nct_id>NCT03266601</nct_id>
  </id_info>
  <brief_title>Effect of Recombinant Human Interferon α-2b Spray on Herpangina</brief_title>
  <official_title>Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tianjin Sinobioway Biomedicine Co.Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hunan Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yuying Children's Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Children's Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Kaifeng City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zunyi Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anhui Provincial Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness&#xD;
      of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric&#xD;
      patients with herpangina.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The defervesce rate during treatment by 72 hours</measure>
    <time_frame>Measure the body temperature every 4 hours from starting of treatment to the 96th hour.</time_frame>
    <description>Body temperature returned to normal,and remain at least 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abnormal blood routine</measure>
    <time_frame>Before admission and 72th hours after treatment.</time_frame>
    <description>White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as &quot;1&quot;, if five indicators all are normal, abnormal blood routine is defined as &quot;0&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The significant efficiency rate</measure>
    <time_frame>From starting of treatment to the 48th hour.</time_frame>
    <description>Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effective rate</measure>
    <time_frame>From starting of treatment to the 72th hour.</time_frame>
    <description>Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ineffective rate</measure>
    <time_frame>From starting of treatment to the 96th hour.</time_frame>
    <description>After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total effective rate</measure>
    <time_frame>From starting of treatment to the 96th hour.</time_frame>
    <description>Total effective rate = efficiency rate + effective rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospital stay</measure>
    <time_frame>From starting of treatment to the 96th hour.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite improvement</measure>
    <time_frame>From starting of treatment to the 96th hour.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial enzymes and electrocardiogram</measure>
    <time_frame>Before admission and 72th hours after treatment.</time_frame>
    <description>Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The condition of herpes and ulcers subside</measure>
    <time_frame>Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.</time_frame>
    <description>Clinical examination to check herpes subsided, ulcer wounds smaller, with or</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">668</enrollment>
  <condition>Herpangina</condition>
  <arm_group>
    <arm_group_label>Recombinant Human Interferon α-2b Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ribavirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant Human Interferon α-2b Spray</intervention_name>
    <description>Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).</description>
    <arm_group_label>Recombinant Human Interferon α-2b Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).</description>
    <arm_group_label>Ribavirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects should meet all of the following:&#xD;
&#xD;
          1. meet the diagnostic criteria for pediatric herpangina;&#xD;
&#xD;
          2. ages 1-7 years, no limitation for gender;&#xD;
&#xD;
          3. within 72 hours of onset;&#xD;
&#xD;
          4. the main organs (heart, liver, kidney and lung) function normally;&#xD;
&#xD;
          5. follow up according to requirements and be hospitalized for observation;&#xD;
&#xD;
          6. the guardian is fully informed and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects should be excluded if meet any of the following:&#xD;
&#xD;
          1. have allergy history of interferon;&#xD;
&#xD;
          2. heart failure, respiratory insufficiency,liver and kidney dysfunction or severe&#xD;
             malnutrition and other serious disease, or immunodeficient;&#xD;
&#xD;
          3. children with epilepsy or other neurological disorders;&#xD;
&#xD;
          4. other pathogens exist at the same time;&#xD;
&#xD;
          5. the researchers believe that it is not appropriate to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>201102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Fudan University</investigator_affiliation>
    <investigator_full_name>Hui Yu</investigator_full_name>
    <investigator_title>Professor, Director</investigator_title>
  </responsible_party>
  <keyword>Aged 1-7 years old, within 72 hours of onset patients with herpangina</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpangina</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Ribavirin</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/NCT03266601
org study id: AFL-2015-2.0
nct id: NCT03266601
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness
      of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric
      patients with herpangina.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The defervesce rate during treatment by 72 hours
time frame: Measure the body temperature every 4 hours from starting of treatment to the 96th hour.
description: Body temperature returned to normal,and remain at least 24 hours.
measure: Abnormal blood routine
time frame: Before admission and 72th hours after treatment.
description: White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as "1", if five indicators all are normal, abnormal blood routine is defined as "0".
measure: The significant efficiency rate
time frame: From starting of treatment to the 48th hour.
description: Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved.
measure: The effective rate
time frame: From starting of treatment to the 72th hour.
description: Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved.
measure: The ineffective rate
time frame: From starting of treatment to the 96th hour.
description: After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty.
measure: The total effective rate
time frame: From starting of treatment to the 96th hour.
description: Total effective rate = efficiency rate + effective rate.
measure: Total hospital stay
time frame: From starting of treatment to the 96th hour.
measure: Appetite improvement
time frame: From starting of treatment to the 96th hour.
measure: Myocardial enzymes and electrocardiogram
time frame: Before admission and 72th hours after treatment.
description: Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.
measure: The condition of herpes and ulcers subside
time frame: Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.
description: Clinical examination to check herpes subsided, ulcer wounds smaller, with or
arm group label: Recombinant Human Interferon α-2b Spray
arm group type: Experimental
arm group label: Ribavirin
arm group type: Active Comparator
intervention type: Drug
intervention name: Recombinant Human Interferon α-2b Spray
description: Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).
arm group label: Recombinant Human Interferon α-2b Spray
intervention type: Drug
intervention name: Ribavirin
description: Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).
arm group label: Ribavirin
criteria: 
gender: All
minimum age: 1 Year
maximum age: 7 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Fudan University
investigator full name: Hui Yu
investigator title: Professor, Director
mesh term: Herpangina
mesh term: Interferons
mesh term: Ribavirin