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/NCT06007417</url>
    </required_header>
    <id_info>
      <org_study_id>GenSci004-301</org_study_id>
      <nct_id>NCT06007417</nct_id>
    </id_info>
    <brief_title>A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency</brief_title>
    <acronym>ELEVATE</acronym>
    <official_title>The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)</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 study is to evaluate the efficacy and safety of weekly GenSci004 compared&#xD;
        with daily Genotropin in treatment-naive children with growth failure due to GHD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of&#xD;
        weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve&#xD;
        children with growth failure due to GHD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">August 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups</measure>
      <time_frame>52 weeks</time_frame>
      <description>Measured in centimeter per year (cm/year)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups</measure>
      <time_frame>104 weeks</time_frame>
      <description>Measured in centimeter per year (cm/year)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">162</enrollment>
    <condition>GHD</condition>
    <arm_group>
      <arm_group_label>GenSci004</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Genotropin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GenSci004</intervention_name>
      <description>GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)</description>
      <arm_group_label>GenSci004</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Genotropin</intervention_name>
      <description>Genotropin</description>
      <arm_group_label>Genotropin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Prepubertal children with GHD in Tanner Stage 1&#xD;
  &#xD;
            2. Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).&#xD;
  &#xD;
            3. Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.&#xD;
  &#xD;
            4. Growth hormone stimulation tests: ≤10 ng/mL&#xD;
  &#xD;
            5. Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for&#xD;
               age and sex (IGF 1 SDS ≤-1.0)&#xD;
  &#xD;
            6. Normal 46 XX karyotype for girls.&#xD;
  &#xD;
            7. Children with multiple hormonal deficiencies must be on stable replacement therapy for&#xD;
               other hypothalamo-pituitary axes for at least 3 months&#xD;
  &#xD;
            8. Written, signed informed consent of the parent(s) or legal guardian(s) of the&#xD;
               participant and written assent of the participant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. BA≥CA&#xD;
  &#xD;
            2. Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.&#xD;
  &#xD;
            3. Major medical conditions or presence of contraindication to human growth hormone (hGH)&#xD;
               treatment&#xD;
  &#xD;
            4. Participation in any other trial of an investigational agent within 3 months prior to&#xD;
               Screening.&#xD;
  &#xD;
            5. Any reason per investigator's discretion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bradley Miller</last_name>
      <role>Study Chair</role>
      <affiliation>University of Minnesota</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Peng Duan</last_name>
      <phone>+86-431-85195060</phone>
      <email>info@gensci-china.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cook Childrens</name>
        <address>
          <city>Fort Worth</city>
          <state>Texas</state>
          <zip>76104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Gomez</last_name>
      </contact>
      <investigator>
        <last_name>Paul Thornton, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 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>No</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/NCT06007417
  org study id: GenSci004-301
  nct id: NCT06007417
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared
        with daily Genotropin in treatment-naive children with growth failure due to GHD.
  The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of
        weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve
        children with growth failure due to GHD.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
  time frame: 52 weeks
  description: Measured in centimeter per year (cm/year)
  measure: Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
  time frame: 104 weeks
  description: Measured in centimeter per year (cm/year)
  arm group label: GenSci004
  arm group type: Experimental
  arm group label: Genotropin
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: GenSci004
  description: GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
  arm group label: GenSci004
  intervention type: Drug
  intervention name: Genotropin
  description: Genotropin
  arm group label: Genotropin
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Bradley Miller
  role: Study Chair
  affiliation: University of Minnesota
  last name: Peng Duan
  phone: +86-431-85195060
  email: info@gensci-china.com
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No