<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/NCT03245333</url>
  </required_header>
  <id_info>
    <org_study_id>GenSci 030 CT-III</org_study_id>
    <nct_id>NCT03245333</nct_id>
  </id_info>
  <brief_title>A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)</brief_title>
  <official_title>Phase Ⅲ Clinical Study of Recombinant Human Growth Hormone Injection (JINTOPIN AQ) for Short Children With Small for Gestational Age(SGA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changchun GeneScience Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Children's Hospital of Zhejiang University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changchun GeneScience Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short&#xD;
      SGA children, further to evaluate the efficacy and safety of the treatment of short SGA&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2014</start_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 3</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>Change of height standard deviation score for chronological age (△Ht SDSCA)</measure>
    <time_frame>52 weeks</time_frame>
    <description>△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height（Ht）at the end of treatment</measure>
    <time_frame>Stage 1：52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height（Ht）at the end of treatment</measure>
    <time_frame>Stage 2：Every 52 weeks, up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized height velocity (HV)</measure>
    <time_frame>Stage 1：52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized height velocity (HV)</measure>
    <time_frame>Stage 2：Every 52 weeks, up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone age maturation</measure>
    <time_frame>Stage 1：52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone age maturation</measure>
    <time_frame>Stage 2：Every 52 weeks, up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mole ratio of IGF-1 and IGFBP-3</measure>
    <time_frame>Stage 1：52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mole ratio of IGF-1 and IGFBP-3</measure>
    <time_frame>Stage 2：Every 52 weeks, up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1 standard deviation score (SDS)</measure>
    <time_frame>Stage 1：52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1 standard deviation score (SDS)</measure>
    <time_frame>Stage 2：Every 52 weeks, up to 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Small for Gestational Age Infant</condition>
  <arm_group>
    <arm_group_label>Stage 1-experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1-negative control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>observed only for 52 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2-experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2-negative control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant Human Growth Hormone Injection</intervention_name>
    <description>Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.</description>
    <arm_group_label>Stage 1-experimental group</arm_group_label>
    <arm_group_label>Stage 1-negative control</arm_group_label>
    <arm_group_label>Stage 2-experimental group</arm_group_label>
    <arm_group_label>Stage 2-negative control</arm_group_label>
    <other_name>rhGH Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant Human Growth Hormone Injection</intervention_name>
    <description>Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.</description>
    <arm_group_label>Stage 1-experimental group</arm_group_label>
    <arm_group_label>Stage 1-negative control</arm_group_label>
    <arm_group_label>Stage 2-experimental group</arm_group_label>
    <arm_group_label>Stage 2-negative control</arm_group_label>
    <other_name>rhGH Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of full-term small for gestational age, SGA.&#xD;
&#xD;
          -  Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.&#xD;
&#xD;
          -  Prepubertal stage (Tanner I).&#xD;
&#xD;
          -  Height was lower than the mean -2SD of the values of normal children of the same age&#xD;
             and gender when participating in the study.&#xD;
&#xD;
          -  A GH peak concentration &gt;10µg/L in a provocative test within a year before&#xD;
             participating in the study.&#xD;
&#xD;
          -  Bone age&lt;Chronological age+1.&#xD;
&#xD;
          -  Normal glucose regulation：Fasting blood-glucose &lt; 5.6mmol/L, and 2 hours postprandial&#xD;
             blood-glucose &lt; 7.8mmol/L.&#xD;
&#xD;
          -  Gestational age was 37 to 42 weeks.&#xD;
&#xD;
          -  The subjects and their guardians signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with Liver and renal insufficiency (ALT &gt; 1.5 times of upper limit of normal&#xD;
             value, Cr&gt; upper limit of normal value).&#xD;
&#xD;
          -  Patients are positive for antibodies to hepatitis B core (HBc), hepatitis B surface&#xD;
             antigen (HBsAg) or hepatitis B e antigen (HBeAg).&#xD;
&#xD;
          -  Known Highly allergic constitution or allergic to the test drug.&#xD;
&#xD;
          -  Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and&#xD;
             hematological diseases, malignant tumors, or systemic infection, immunocompromised&#xD;
             patients and patients with psychosis.&#xD;
&#xD;
          -  Subjects with other growth disorders, such as Turner syndrome, constitutional delay of&#xD;
             growth and puberty, and Laron syndrome and growth hormone receptor deficiency.&#xD;
&#xD;
          -  Subjects who have received the treatment of GH.&#xD;
&#xD;
          -  Subjects took part in other clinical trial study within 3 months.&#xD;
&#xD;
          -  Children who have treated with other hormone (such as gonadal hormone and&#xD;
             glucocorticoids etc, continuous administration of more than a month) and that may&#xD;
             affect growth hormone secretion or action including oxygen male dragon, growth hormone&#xD;
             releasing hormone, etc. within 3 months.&#xD;
&#xD;
          -  Other conditions which in the opinion of the investigator preclude enrollment into the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiaohua Feng</last_name>
    <phone>0431-85170552</phone>
    <email>fengxiaohua@gensci-china.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoping Luo</last_name>
    <phone>+86-27-83663712</phone>
    <email>xpluo@tjh.tjmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The first affiliated Hospital with Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beijing Children's Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shanghai Children's Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>December 10, 2017</last_update_submitted>
  <last_update_submitted_qc>December 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</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/NCT03245333
org study id: GenSci 030 CT-III
nct id: NCT03245333
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short
      SGA children, further to evaluate the efficacy and safety of the treatment of short SGA
      children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of height standard deviation score for chronological age (△Ht SDSCA)
time frame: 52 weeks
description: △Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )
measure: Height（Ht）at the end of treatment
time frame: Stage 1：52 weeks
measure: Height（Ht）at the end of treatment
time frame: Stage 2：Every 52 weeks, up to 3 years
measure: Annualized height velocity (HV)
time frame: Stage 1：52 weeks
measure: Annualized height velocity (HV)
time frame: Stage 2：Every 52 weeks, up to 3 years
measure: Bone age maturation
time frame: Stage 1：52 weeks
measure: Bone age maturation
time frame: Stage 2：Every 52 weeks, up to 3 years
measure: Mole ratio of IGF-1 and IGFBP-3
time frame: Stage 1：52 weeks
measure: Mole ratio of IGF-1 and IGFBP-3
time frame: Stage 2：Every 52 weeks, up to 3 years
measure: IGF-1 standard deviation score (SDS)
time frame: Stage 1：52 weeks
measure: IGF-1 standard deviation score (SDS)
time frame: Stage 2：Every 52 weeks, up to 3 years
arm group label: Stage 1-experimental group
arm group type: Experimental
description: JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.
arm group label: Stage 1-negative control
arm group type: Other
description: observed only for 52 weeks.
arm group label: Stage 2-experimental group
arm group type: Experimental
description: After completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.
arm group label: Stage 2-negative control
arm group type: Other
description: After completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.
intervention type: Drug
intervention name: Recombinant Human Growth Hormone Injection
description: Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
arm group label: Stage 1-experimental group
arm group label: Stage 1-negative control
arm group label: Stage 2-experimental group
arm group label: Stage 2-negative control
other name: rhGH Injection
intervention type: Drug
intervention name: Recombinant Human Growth Hormone Injection
description: Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.
arm group label: Stage 1-experimental group
arm group label: Stage 1-negative control
arm group label: Stage 2-experimental group
arm group label: Stage 2-negative control
other name: rhGH Injection
criteria: 
gender: All
minimum age: 24 Years
maximum age: 90 Years
healthy volunteers: No
last name: Xiaohua Feng
phone: 0431-85170552
email: fengxiaohua@gensci-china.com
last name: Xiaoping Luo
phone: +86-27-83663712
email: xpluo@tjh.tjmu.edu.cn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Hormones