<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/NCT02976675</url>
  </required_header>
  <id_info>
    <org_study_id>GenSci 004 CT-4</org_study_id>
    <nct_id>NCT02976675</nct_id>
  </id_info>
  <brief_title>Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency</brief_title>
  <official_title>Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changchun GeneScience Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Suzhou Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Henan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal and Child Health Hospital of Hubei Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nantong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changchun GeneScience Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children&#xD;
      with growth hormone deficiency, as well as to study the feasibility of extending the dosing&#xD;
      intervals (once per two weeks) of PEG Somatropin Injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <primary_completion_date type="Anticipated">June 2017</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>Ht SDSca</measure>
    <time_frame>Baseline, 4,12,26 weeks after initiating treatment</time_frame>
    <description>Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ht SDSBA</measure>
    <time_frame>Baseline, 4,12,26 weeks after initiating treatment</time_frame>
    <description>Calculate by formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yearly growth velocity</measure>
    <time_frame>Baseline, 4,12,26 weeks after initiating treatment</time_frame>
    <description>Calculate by formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1SDS</measure>
    <time_frame>Baseline, 4,12,26 weeks after initiating treatment</time_frame>
    <description>Calculate by formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1/IGFBP-3 molar ratio</measure>
    <time_frame>Baseline, 4,12,26 weeks after initiating treatment</time_frame>
    <description>Calculate by formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone age</measure>
    <time_frame>Baseline, 4,12,26 weeks after initiating treatment</time_frame>
    <description>Calculate by formula</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>PEG-somatropin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG-somatropin per two weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jintropin AQ</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PEG-somatropin</intervention_name>
    <description>Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks</description>
    <arm_group_label>Jintropin AQ</arm_group_label>
    <arm_group_label>PEG-somatropin</arm_group_label>
    <arm_group_label>PEG-somatropin per two weeks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PEG-somatropin</intervention_name>
    <description>Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks</description>
    <arm_group_label>Jintropin AQ</arm_group_label>
    <arm_group_label>PEG-somatropin</arm_group_label>
    <arm_group_label>PEG-somatropin per two weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects are diagnosed as GHD before starting treatment, according to medical history,&#xD;
             clinical symptoms and signs, GH provocation tests and imaging and other examinations:&#xD;
&#xD;
               1. According to statistical height data of physical development of Chinese children&#xD;
                  in nine cities in 2005, the height is lower than 3rd percentile growth curve of&#xD;
                  the same age, same sex normal children;&#xD;
&#xD;
               2. Height velocity (HV) ≤5.0 cm / yr;&#xD;
&#xD;
               3. GH provocative tests (with two drugs of different mechanism of action) confirmed&#xD;
                  plasma GH peak &lt;10.0 ng / ml;&#xD;
&#xD;
               4. bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more&#xD;
                  later than the actual age, that is the actual age - bone age ≥ 1 year;&#xD;
&#xD;
          -  Before puberty (Tanner I stage), age≥3 years old, male or female;&#xD;
&#xD;
          -  Subjects have not received hormone therapy within 6 months;&#xD;
&#xD;
          -  Subjects is willing and able to cooperate to complete scheduled visits, treatment&#xD;
             plans and laboratory tests and other procedures, to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dysfunction of liver and kidney (ALT&gt; 2 times the upper limit of normal, Cr&gt; upper&#xD;
             limit of normal);&#xD;
&#xD;
          -  Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen&#xD;
             (HBsAg) or hepatitis B e antigen (HBeAg);&#xD;
&#xD;
          -  Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other&#xD;
             components of the study product;&#xD;
&#xD;
          -  Patients with severe cardiopulmonary or hematological diseases, a current or past&#xD;
             history of malignant tumors, immunodeficiency diseases, or mental diseases;&#xD;
&#xD;
          -  Potential cancer patients (family history);&#xD;
&#xD;
          -  Patients with diabetics;&#xD;
&#xD;
          -  Patients with other growth disorders, such as Turner's syndrome, sexual physical&#xD;
             delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly&#xD;
             growing who did not rule out chromosomal abnormalities;&#xD;
&#xD;
          -  Patients with congenital bone dysplasia or scoliosis;&#xD;
&#xD;
          -  Subjects took part in other clinical trial study during 3 months;&#xD;
&#xD;
          -  Other conditions in which the investigator preclude enrollment into the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feihong Luo, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaohua Feng</last_name>
    <phone>13610794989</phone>
    <email>fengxiaohua@gensci-china.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Maternal and Child Health Hospital of Anhui province</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First People's Hospital of Lu'an City</name>
      <address>
        <city>Lu'an</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Second Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maternal and Child Health Hospital of Guiyang City</name>
      <address>
        <city>Guiyangtou</city>
        <state>Guizhou</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maternal and Child Health Hospital of Hainan province</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hebei Provincial People's Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Henan University of Science and Technology</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maternal and Child Health Hospital of Hubei province</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First People's Hospital of Changzhou City</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First People's Hospital of Lianyungang City</name>
      <address>
        <city>Lianyungang</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Provincial Hospital of Chinese Traditional medicine</name>
      <address>
        <city>Nanjingkou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Nantong University</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Suzhou City Hospital</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maternal and Child Health Hospital of Tai'an city</name>
      <address>
        <city>Tai'an</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Chengdu city</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Cixi City</name>
      <address>
        <city>Cixi</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First People's Hospital of Jiaxing City</name>
      <address>
        <city>Jiaxing</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jinhua Central Hospital</name>
      <address>
        <city>Jinhua</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jishuitan Hospital of Beijing City</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peoples' hospital of Inner Mongolia Autonomous Region</name>
      <address>
        <city>Inner Mongolia Autonomous Region</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Ningxia Autonomous Region</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feihong Luo, Doctor</last_name>
      <phone>18017590900</phone>
      <email>luo_fh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>June 14, 2017</last_update_submitted>
  <last_update_submitted_qc>June 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 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>Dwarfism, Pituitary</mesh_term>
    <mesh_term>Endocrine System Diseases</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/NCT02976675
org study id: GenSci 004 CT-4
nct id: NCT02976675
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children
      with growth hormone deficiency, as well as to study the feasibility of extending the dosing
      intervals (once per two weeks) of PEG Somatropin Injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ht SDSca
time frame: Baseline, 4,12,26 weeks after initiating treatment
description: Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age
measure: Ht SDSBA
time frame: Baseline, 4,12,26 weeks after initiating treatment
description: Calculate by formula
measure: Yearly growth velocity
time frame: Baseline, 4,12,26 weeks after initiating treatment
description: Calculate by formula
measure: IGF-1SDS
time frame: Baseline, 4,12,26 weeks after initiating treatment
description: Calculate by formula
measure: IGF-1/IGFBP-3 molar ratio
time frame: Baseline, 4,12,26 weeks after initiating treatment
description: Calculate by formula
measure: Bone age
time frame: Baseline, 4,12,26 weeks after initiating treatment
description: Calculate by formula
arm group label: PEG-somatropin
arm group type: Experimental
description: Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
arm group label: PEG-somatropin per two weeks
arm group type: Experimental
description: Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
arm group label: Jintropin AQ
arm group type: Active Comparator
description: Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks
intervention type: Biological
intervention name: PEG-somatropin
description: Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
arm group label: Jintropin AQ
arm group label: PEG-somatropin
arm group label: PEG-somatropin per two weeks
intervention type: Biological
intervention name: PEG-somatropin
description: Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
arm group label: Jintropin AQ
arm group label: PEG-somatropin
arm group label: PEG-somatropin per two weeks
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Feihong Luo, Doctor
role: Principal Investigator
affiliation: Children's Hospital of Fudan University
last name: Xiaohua Feng
phone: 13610794989
email: fengxiaohua@gensci-china.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
mesh term: Endocrine System Diseases