<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/NCT03249480</url>
  </required_header>
  <id_info>
    <org_study_id>GenSci 004 CT-GCX</org_study_id>
    <nct_id>NCT03249480</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, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changchun GeneScience Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalian Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xian Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fuzhou Children s Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anhui Provincial Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hunan Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Hebei Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhengzhou Children's Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kunming Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First People's Hospital of Yunnan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xuzhou Children's Hopspital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Henan University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Union Hospital of Tongji Medical College of HUST</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuxi Women's &amp; Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanjing Children's Hospital</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>
      To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with&#xD;
      growth hormone deficiency, as well as to study the dosage of PEG Somatropin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 4</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>Ht SDSca (Height Standard Deviation Score for Chronological Age)</measure>
    <time_frame>Baseline</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>
  <primary_outcome>
    <measure>Change of yearly growth velocity from baseline to 26 weeks</measure>
    <time_frame>Baseline, 26 weeks after initiating treatment</time_frame>
    <description>Height velocity calculate by formula</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ht SDSca</measure>
    <time_frame>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 (Height Standard Deviation Score for Bone Age)</measure>
    <time_frame>Baseline,26 weeks after initiating treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1 SDS (IGF-1 Standard Deviation Score)</measure>
    <time_frame>Baseline,26 weeks after initiating treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)</measure>
    <time_frame>Baseline,26 weeks after initiating treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal maturity</measure>
    <time_frame>Baseline,26 weeks after initiating treatment</time_frame>
    <description>Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">900</enrollment>
  <condition>Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>PEG-somatropin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PEG-somatropin</intervention_name>
    <description>30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.</description>
    <arm_group_label>PEG-somatropin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as GHD before starting treatment, according to medical history, clinical&#xD;
             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;
          -  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>Chunxiu Gong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Children's Hospital</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>Anhui Provincial Children's Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fuzhou Children s Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen Memorial Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiangzhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Hebei Province</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Zhengzhou</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henan Provincal People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan University of TCM</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Union Hospital, Tongji Medical College, HUST</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wuhan Children's Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hunan Children's Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maternal &amp; Child Health Hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nanjing Children's Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wuxi Children's Hospital</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Xuzhou Children's Hpspital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dalian Children's Hospital</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Xi'an Children's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kunming Children's Hospital</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Yunnan Province</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shenzhen Children's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</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 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 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/NCT03249480
org study id: GenSci 004 CT-GCX
nct id: NCT03249480
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with
      growth hormone deficiency, as well as to study the dosage of PEG Somatropin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ht SDSca (Height Standard Deviation Score for Chronological Age)
time frame: Baseline
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: Change of yearly growth velocity from baseline to 26 weeks
time frame: Baseline, 26 weeks after initiating treatment
description: Height velocity calculate by formula
measure: Ht SDSca
time frame: 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 (Height Standard Deviation Score for Bone Age)
time frame: Baseline,26 weeks after initiating treatment
measure: IGF-1 SDS (IGF-1 Standard Deviation Score)
time frame: Baseline,26 weeks after initiating treatment
measure: IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)
time frame: Baseline,26 weeks after initiating treatment
measure: Skeletal maturity
time frame: Baseline,26 weeks after initiating treatment
description: Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration
arm group label: PEG-somatropin
arm group type: Experimental
description: 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
intervention type: Biological
intervention name: PEG-somatropin
description: 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
arm group label: PEG-somatropin
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Chunxiu Gong
role: Principal Investigator
affiliation: Beijing Children's Hospital
last name: Xiaohua Feng
phone: 13610794989
email: fengxiaohua@gensci-china.com
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
mesh term: Endocrine System Diseases