<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/NCT03290235</url>
  </required_header>
  <id_info>
    <org_study_id>GenSci 045 CT-Extension Period</org_study_id>
    <nct_id>NCT03290235</nct_id>
  </id_info>
  <brief_title>Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children</brief_title>
  <official_title>The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changchun GeneScience Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>
      1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of&#xD;
           children with growth hormone deficiency for a relatively long period&#xD;
&#xD;
        2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the&#xD;
           height prediction model based on Chinese children with short stature, and to provide the&#xD;
           basis and guidance for standard and reasonable long-term clinical application of&#xD;
           PEG-Somatropin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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 (Height standard deviation score for chronological age)</measure>
    <time_frame>Baseline, every 13 weeks until 130 weeks</time_frame>
    <description>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 (Height standard deviation score for bone age)</measure>
    <time_frame>Baseline, every 13 weeks until 130 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yearly growth velocity</measure>
    <time_frame>Baseline, every 13 weeks until 130 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)</measure>
    <time_frame>Baseline, every 13 weeks until 130 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone age</measure>
    <time_frame>Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Near final height for some subjects</measure>
    <time_frame>Baseline, every 13 weeks until 130 weeks</time_frame>
    <description>When yearly growth velocity of some subject is no more than 2cm/year.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Growth Retardation</condition>
  <arm_group>
    <arm_group_label>PEG-somatropin-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosage 0.2mg/kg/w</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG-somatropin-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosage 0.1-0.2mg/kg/w</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG-somatropin</intervention_name>
    <description>Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit</description>
    <arm_group_label>PEG-somatropin-1</arm_group_label>
    <arm_group_label>PEG-somatropin-2</arm_group_label>
    <other_name>Jintrolong®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children has completed all visits and therapy in previous phase IV study;&#xD;
&#xD;
          -  Investigators evaluate subjects could continue growth hormone therapy;&#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;
          -  Children with epiphyseal closure;&#xD;
&#xD;
          -  Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age&#xD;
             ≥ 14 years old for girls, bone age ≥ 16 years old for boys;&#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 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;
          -  Patients with diabetics;&#xD;
&#xD;
          -  Patients with congenital bone dysplasia or scoliosis;&#xD;
&#xD;
          -  Patients took drugs that would influence the efficacy and safety of PEG-Somatropin&#xD;
             after phase IV study and before screening for this extension study;&#xD;
&#xD;
          -  Other conditions in which the investigator preclude enrollment into the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Months</minimum_age>
    <maximum_age>15 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>
  <location>
    <facility>
      <name>TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science &amp; Teconology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 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>
  <!-- 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/NCT03290235
org study id: GenSci 045 CT-Extension Period
nct id: NCT03290235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of
           children with growth hormone deficiency for a relatively long period

        2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the
           height prediction model based on Chinese children with short stature, and to provide the
           basis and guidance for standard and reasonable long-term clinical application of
           PEG-Somatropin.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ht SDSca (Height standard deviation score for chronological age)
time frame: Baseline, every 13 weeks until 130 weeks
description: 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 (Height standard deviation score for bone age)
time frame: Baseline, every 13 weeks until 130 weeks
measure: Yearly growth velocity
time frame: Baseline, every 13 weeks until 130 weeks
measure: IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)
time frame: Baseline, every 13 weeks until 130 weeks
measure: Bone age
time frame: Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks
measure: Near final height for some subjects
time frame: Baseline, every 13 weeks until 130 weeks
description: When yearly growth velocity of some subject is no more than 2cm/year.
arm group label: PEG-somatropin-1
arm group type: Experimental
description: Dosage 0.2mg/kg/w
arm group label: PEG-somatropin-2
arm group type: Experimental
description: Dosage 0.1-0.2mg/kg/w
intervention type: Drug
intervention name: PEG-somatropin
description: Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit
arm group label: PEG-somatropin-1
arm group label: PEG-somatropin-2
other name: Jintrolong®
criteria: 
gender: All
minimum age: 42 Months
maximum age: 15 Years
healthy volunteers: No
last name: Xiaohua Feng
phone: 0431-85170552
email: fengxiaohua@gensci-china.com
facility: 
status: Recruiting
country: China
responsible party type: Sponsor