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/NCT06024967</url>
    </required_header>
    <id_info>
      <org_study_id>GenSci004-302</org_study_id>
      <nct_id>NCT06024967</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency</brief_title>
    <acronym>ESCALATE</acronym>
    <official_title>The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study</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>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly&#xD;
        GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly&#xD;
        GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</primary_completion_date>
    <phase>Phase 3</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>Adverse Events of once-weekly GenSci004 in children with GHD</measure>
      <time_frame>108 weeks</time_frame>
      <description>Incidents of adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Annualized Height Velocity (AHV)</measure>
      <time_frame>104 weeks</time_frame>
      <description>Measured in centimeter per year (cm/year)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>GHD</condition>
    <arm_group>
      <arm_group_label>GenSci004</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PEG-somatropin</intervention_name>
      <description>PEG-somatropin</description>
      <arm_group_label>GenSci004</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Investigator-determined diagnosis of GHD prior to the historical initiation of daily&#xD;
               rhGH trerapy&#xD;
  &#xD;
            2. Participant must be 6 months to 17 years old&#xD;
  &#xD;
            3. Tanner stage &lt;5 at Visit 1&#xD;
  &#xD;
            4. Open epiphyses&#xD;
  &#xD;
            5. Normal fundoscopy at Screening&#xD;
  &#xD;
            6. Written, signed, informed consent of the participant's parent(s)/LAR(s) and written&#xD;
               assent of the participant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History or presence of malignant disease&#xD;
  &#xD;
            2. Children with diabetes mellitus&#xD;
  &#xD;
            3. Major medical conditions and/or presence of contraindications to GH treatment&#xD;
  &#xD;
            4. Pregnancy&#xD;
  &#xD;
            5. Participation in any other study of an investigational agent within three months prior&#xD;
               to Visit 1&#xD;
  &#xD;
            6. Prior exposure to investigational drug or any other long-acting growth hormone&#xD;
  &#xD;
            7. Any other reason per investigator's discretion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lawrence Silverman, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Morristown Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Duan Peng</last_name>
      <phone>+86-431-85195060</phone>
      <email>info@gensci-china.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>GHD</keyword>
    <keyword>growth hormone deficiency</keyword>
    <patient_data>
      <sharing_ipd>Yes</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/NCT06024967
  org study id: GenSci004-302
  nct id: NCT06024967
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly
        GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
  The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly
        GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Adverse Events of once-weekly GenSci004 in children with GHD
  time frame: 108 weeks
  description: Incidents of adverse events
  measure: Annualized Height Velocity (AHV)
  time frame: 104 weeks
  description: Measured in centimeter per year (cm/year)
  arm group label: GenSci004
  arm group type: Experimental
  intervention type: Drug
  intervention name: PEG-somatropin
  description: PEG-somatropin
  arm group label: GenSci004
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 17 Years
  healthy volunteers: No
  last name: Lawrence Silverman, MD
  role: Study Chair
  affiliation: Morristown Medical Center
  last name: Duan Peng
  phone: +86-431-85195060
  email: info@gensci-china.com
  responsible party type: Sponsor
  sharing ipd: Yes