<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/NCT02204163</url>
  </required_header>
  <id_info>
    <org_study_id>LG-HGCL007</org_study_id>
    <nct_id>NCT02204163</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome</brief_title>
  <official_title>A Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With Prader-Willi Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Life Sciences</source>
  <brief_summary>
    <textblock>
      Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in&#xD;
      infants/toddlers with Prader-Willi syndrome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Change from baseline in height SDS (Standard Deviation Score)</measure>
    <time_frame>baseline and 52 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Lean body mass (g)</measure>
    <time_frame>baseline and 52 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Percent body fat (%)</measure>
    <time_frame>baseline and 52 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in height velocity (cm/year)</measure>
    <time_frame>baseline, 16, 28 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in head circumference (cm)</measure>
    <time_frame>baseline, 16, 28 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cognitive development (score) by Bayley Scale</measure>
    <time_frame>baseline, 28 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in motor development (score) by Bayley Scale</measure>
    <time_frame>baseline, 28 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in weight SDS</measure>
    <time_frame>baseline 16, 28 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in BMI (kg/m2) (Body Mass Index)</measure>
    <time_frame>baseline, 16, 28 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Bone age (month)</measure>
    <time_frame>baseline and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Bone mineral density (g/cm)</measure>
    <time_frame>baseline and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in height (cm)</measure>
    <time_frame>baseline, 16, 28 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in height SDS</measure>
    <time_frame>baseline, 16 and 28 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in IGF-1 (ng/mL) and IGF-1 SDS</measure>
    <time_frame>baseline, 28, and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in IGFBP-3 (ng/mL) and IGFBP-3 SDS</measure>
    <time_frame>baseline, 28, and 52 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Prader-Willi Syndrome</condition>
  <arm_group>
    <arm_group_label>Eutropin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eutropin 0.24mg/kg/week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genotropin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Genotropin 0.24mg/kg/week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eutropin</intervention_name>
    <arm_group_label>Eutropin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genotropin</intervention_name>
    <arm_group_label>Genotropin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               1. Pediatric patients with PWS confirmed by methylation PCR genetic testing&#xD;
&#xD;
               2. Prepubertal pediatric patients (Tanner's Pubertal stage I) at screening&#xD;
&#xD;
               3. Pediatric patients who have never been treated with hGH prior to screening, or&#xD;
                  who had been treated with hGH for less than 6 months if they had a treatment&#xD;
                  history, and whose last administration was made 6 months prior to screening&#xD;
&#xD;
               4. Pediatric patients with normal thyroid function at screening (Those with normal&#xD;
                  function through a hormonal therapy were allowable.)&#xD;
&#xD;
               5. Pediatric patients whose parents or LARs signed the informed consent form in&#xD;
                  writing after receiving the explanation about the purpose, method, effects, etc.&#xD;
                  of the clinical study, and who also signed the informed consent form in writing&#xD;
                  if they are capable of reading and understanding writing.&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               1. Pediatric patients who are accompanied by other causes for growth retardation as&#xD;
                  follows except for PWS at screening&#xD;
&#xD;
                  : Chronic renal failure (including the case in which renal transplantation has&#xD;
                  been undergone), Silver-Russell syndrome, Turner's syndrome, Seckel syndrome,&#xD;
                  Down's syndrome, Noonan syndrome, Cushing's syndrome, congenital infections,&#xD;
                  psychiatric disorders, chronic debilitating diseases, etc.&#xD;
&#xD;
               2. Pediatric patients with malignancy or a history of malignancy at screening&#xD;
&#xD;
               3. Pediatric patients with severe respiratory disturbance, or sleep apnoea or a&#xD;
                  history of respiratory infections with an unknown cause at screening. However,&#xD;
                  those whose condition had been confirmed to be eligible to participate in the&#xD;
                  clinical study on investigator's judgment were allowed to participae in the&#xD;
                  study.&#xD;
&#xD;
               4. Pediatric patients with impaired fasting glucose, diabetes, and diabetic&#xD;
                  retinopathy at screening&#xD;
&#xD;
               5. Pediatric patients whose epiphyses are closed with a growth rate of ≤1 cm/year at&#xD;
                  screening&#xD;
&#xD;
               6. Pediatric patients who are being administered any drug that may have an effect on&#xD;
                  the secretion and actions of hGH (estrogen, androgen, anabolic steroids,&#xD;
                  corticosteroids, GnRH analogs, thyroxine, aromatase inhibitors, etc.) or&#xD;
                  anticonvulsants and cyclosporin at screening, and have been administered any of&#xD;
                  them for a long period of time within 6 months prior to screening (However, those&#xD;
                  who have been administered a thyroxine preparation for ≥4 weeks on a stable dose&#xD;
                  [allowable in case the investigator determines the dose is stable even though it&#xD;
                  is changeable based upon the weight of the pediatric patient] were allowed to&#xD;
                  participate in the clinical study.)&#xD;
&#xD;
               7. Pediatric patients who are being administered any drug (e.g. methylphenidate) for&#xD;
                  treatment of hyperactivity disorders including attention deficit hyperactivity&#xD;
                  disorder (ADHD) at screening&#xD;
&#xD;
               8. Pediatric patients who are hypersensitive to somatropin or any excipient of the&#xD;
                  investigational product (cresol or glycerol) or who have a relevant history of&#xD;
                  hypersensitivity&#xD;
&#xD;
               9. Pediatric patients who have participated in any other clinical studies after&#xD;
                  enrolled in this study or who had participated in any other clinical studies&#xD;
                  within 3 months prior to enrollment in this clinical study&#xD;
&#xD;
              10. Pediatric patients in whom this clinical study is considered to be difficult to&#xD;
                  be conducted for any other reasons on investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2019</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>Prader-Willi Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02204163
org study id: LG-HGCL007
nct id: NCT02204163
lead sponsor: 
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in
      infants/toddlers with Prader-Willi syndrome
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in height SDS (Standard Deviation Score)
time frame: baseline and 52 weeks
measure: Change from baseline in Lean body mass (g)
time frame: baseline and 52 weeks
measure: Change from baseline in Percent body fat (%)
time frame: baseline and 52 weeks
measure: Change from baseline in height velocity (cm/year)
time frame: baseline, 16, 28 and 52 weeks
measure: Change from baseline in head circumference (cm)
time frame: baseline, 16, 28 and 52 weeks
measure: Change from baseline in cognitive development (score) by Bayley Scale
time frame: baseline, 28 and 52 weeks
measure: Change from baseline in motor development (score) by Bayley Scale
time frame: baseline, 28 and 52 weeks
measure: Change from baseline in weight SDS
time frame: baseline 16, 28 and 52 weeks
measure: Change from baseline in BMI (kg/m2) (Body Mass Index)
time frame: baseline, 16, 28 and 52 weeks
measure: Change from baseline in Bone age (month)
time frame: baseline and 52 weeks
measure: Change from baseline in Bone mineral density (g/cm)
time frame: baseline and 52 weeks
measure: Change from baseline in height (cm)
time frame: baseline, 16, 28 and 52 weeks
measure: Change from baseline in height SDS
time frame: baseline, 16 and 28 weeks
measure: Change from baseline in IGF-1 (ng/mL) and IGF-1 SDS
time frame: baseline, 28, and 52 weeks
measure: Change from baseline in IGFBP-3 (ng/mL) and IGFBP-3 SDS
time frame: baseline, 28, and 52 weeks
arm group label: Eutropin
arm group type: Experimental
description: Eutropin 0.24mg/kg/week
arm group label: Genotropin
arm group type: Active Comparator
description: Genotropin 0.24mg/kg/week
intervention type: Drug
intervention name: Eutropin
arm group label: Eutropin
intervention type: Drug
intervention name: Genotropin
arm group label: Genotropin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Prader-Willi Syndrome
mesh term: Syndrome