xml: <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/NCT06037473</url>
    </required_header>
    <id_info>
      <org_study_id>Gensci-LAGH-23003</org_study_id>
      <nct_id>NCT06037473</nct_id>
    </id_info>
    <brief_title>The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg</brief_title>
    <official_title>A Real-world Study of the Efficacy and Safety of PEGylated Recombinant Human Growth Hormone Injection in the Treatment of Short Stature in Chinese Children From the Global Registry for Novel Therapies For Rare Bone or Endocrine Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Office for Rare Conditions Registries, University of Glasgow</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Beijing Children's Hospital</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>
        In order to further observe the long-term safety and effectiveness of real-world polyethylene&#xD;
        glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature,&#xD;
        and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and&#xD;
        the height prediction model after treatment, etc., collect and analyze more scientifically&#xD;
        and rationally, and understand the situation of real-world PEG-GH treatment. A database&#xD;
        registration study was developed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A database registration study was developed to retrospectively analyze the efficacy and&#xD;
        safety of polyethylene glycol recombinant human growth hormone injection in the treatment of&#xD;
        slow growth in children caused by endogenous growth hormone deficiency, idiopathic short&#xD;
        stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order&#xD;
        to participate in the global real-world use of long-acting growth hormone, all data from this&#xD;
        study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and&#xD;
        Bone Disorders (GloBE-Reg) platform.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2029</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the change in height standard deviation score</measure>
      <time_frame>3-10years</time_frame>
      <description>final adult height standard deviation score- height standard deviation score before treatment</description>
    </primary_outcome>
    <number_of_groups>5</number_of_groups>
    <enrollment type="Anticipated">2600</enrollment>
    <condition>Growth Hormone Treatment</condition>
    <condition>Growth Disorders</condition>
    <arm_group>
      <arm_group_label>growth hormone deficiency(GHD)</arm_group_label>
      <description>Growth hormone deficiency (GHD) is a rare and treatable condition that causes short height in children and metabolic issues in adults.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Idiopathic short stature (ISS)</arm_group_label>
      <description>Idiopathic short stature is a condition in which the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population, in whom no identifiable disorder is present.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>small for gestational age (SGA)</arm_group_label>
      <description>Small for gestational age (SGA) is defined as a birth weight of less than 10th percentile for gestational age.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Turner Syndrome (TS)</arm_group_label>
      <description>Turner syndrome, a condition that affects only females, results when one of the X chromosomes (sex chromosomes) is missing or partially missing.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>others</arm_group_label>
      <description>others who with the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Polyethylene glycol recombinant human growth hormone injection</intervention_name>
      <description>0.1-0.3mg/kg.w</description>
      <arm_group_label>Idiopathic short stature (ISS)</arm_group_label>
      <arm_group_label>Turner Syndrome (TS)</arm_group_label>
      <arm_group_label>growth hormone deficiency(GHD)</arm_group_label>
      <arm_group_label>others</arm_group_label>
      <arm_group_label>small for gestational age (SGA)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The height of the patients was below 2 stadard deviation below average. The patients were&#xD;
          diagosesed as endogenous growth hormone deficiency, TS, SGA, ISS, etc. and treated with&#xD;
          polyethylene glycol recombinant human growth hormone injection&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short&#xD;
          stature, etc. treated with polyethylene glycol recombinant human growth hormone injection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with serious heart and lung, blood system, malignant tumors and other diseases or&#xD;
          systemic infections, immune function is low and Persons with mental illness;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bingyan Cao, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Children's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chunxiu Gong, Dr.</last_name>
      <phone>13370115001</phone>
      <email>chunxiugong@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jiajia Chen, Dr.</last_name>
      <phone>13810773718</phone>
      <email>chenjiaj2009@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Endocrinology, Genetics, Metabolism</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>010</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>chunxiu Gong, doctor</last_name>
        <phone>13370115001</phone>
        <phone_ext>59616326</phone_ext>
        <email>chunxiugong@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beijing Children's Hospital</investigator_affiliation>
      <investigator_full_name>Chunxiu Gong</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dwarfism</mesh_term>
      <mesh_term>Growth Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hormones</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037473
  org study id: Gensci-LAGH-23003
  nct id: NCT06037473
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  In order to further observe the long-term safety and effectiveness of real-world polyethylene
        glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature,
        and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and
        the height prediction model after treatment, etc., collect and analyze more scientifically
        and rationally, and understand the situation of real-world PEG-GH treatment. A database
        registration study was developed.
  A database registration study was developed to retrospectively analyze the efficacy and
        safety of polyethylene glycol recombinant human growth hormone injection in the treatment of
        slow growth in children caused by endogenous growth hormone deficiency, idiopathic short
        stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order
        to participate in the global real-world use of long-acting growth hormone, all data from this
        study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and
        Bone Disorders (GloBE-Reg) platform.
  observational model: Cohort
  time perspective: Retrospective
  measure: the change in height standard deviation score
  time frame: 3-10years
  description: final adult height standard deviation score- height standard deviation score before treatment
  arm group label: growth hormone deficiency(GHD)
  description: Growth hormone deficiency (GHD) is a rare and treatable condition that causes short height in children and metabolic issues in adults.
  arm group label: Idiopathic short stature (ISS)
  description: Idiopathic short stature is a condition in which the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population, in whom no identifiable disorder is present.
  arm group label: small for gestational age (SGA)
  description: Small for gestational age (SGA) is defined as a birth weight of less than 10th percentile for gestational age.
  arm group label: Turner Syndrome (TS)
  description: Turner syndrome, a condition that affects only females, results when one of the X chromosomes (sex chromosomes) is missing or partially missing.
  arm group label: others
  description: others who with the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population.
  intervention type: Drug
  intervention name: Polyethylene glycol recombinant human growth hormone injection
  description: 0.1-0.3mg/kg.w
  arm group label: Idiopathic short stature (ISS)
  arm group label: Turner Syndrome (TS)
  arm group label: growth hormone deficiency(GHD)
  arm group label: others
  arm group label: small for gestational age (SGA)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Bingyan Cao, Dr.
  role: Principal Investigator
  affiliation: Beijing Children's Hospital
  last name: Chunxiu Gong, Dr.
  phone: 13370115001
  email: chunxiugong@163.com
  last name: Jiajia Chen, Dr.
  phone: 13810773718
  email: chenjiaj2009@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Beijing Children's Hospital
  investigator full name: Chunxiu Gong
  investigator title: Principal Investigator
  mesh term: Dwarfism
  mesh term: Growth Disorders
  mesh term: Hormones
  sharing ipd: Undecided