<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/NCT02968004</url>
  </required_header>
  <id_info>
    <org_study_id>CP-4-006</org_study_id>
    <nct_id>NCT02968004</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children</brief_title>
  <official_title>A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OPKO Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OPKO Health, Inc.</source>
  <brief_summary>
    <textblock>
      This will be an open-label, randomized, multicenter, efficacy and safety study of weekly&#xD;
      MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone&#xD;
      deficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of a 12 month, open-label, randomized, active controlled, parallel&#xD;
      group study comparing the efficacy and safety of weekly MOD-4023 to daily growth hormone&#xD;
      (GH), Genotropin. After 12 months, subjects will have the option to enter the long term&#xD;
      open-label extension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">August 2019</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>Annual Height Velocity</measure>
    <time_frame>52 weeks</time_frame>
    <description>Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height Velocity at 6 Months</measure>
    <time_frame>After 6 months of treatment</time_frame>
    <description>Height velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Height Standard Deviation Score (SDS)</measure>
    <time_frame>After 6 and 12 months</time_frame>
    <description>Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bone Maturation (BM)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Annual change in bone age measurements as per Gruelich-Pyle method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)</measure>
    <time_frame>Baseline and at 12 months</time_frame>
    <description>Via central lab analysis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Device</measure>
    <time_frame>6 weeks</time_frame>
    <description>Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA</description>
  </other_outcome>
  <other_outcome>
    <measure>Device</measure>
    <time_frame>1 week</time_frame>
    <description>Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">224</enrollment>
  <condition>Pediatric Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>MOD-4023</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genotropin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOD-4023</intervention_name>
    <description>Once weekly subcutaneous injection using pre-filled pen device.</description>
    <arm_group_label>MOD-4023</arm_group_label>
    <other_name>Somatrogon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somatropin</intervention_name>
    <description>Once daily subcutaneous injection of Genotropin using pre-filled pen device.</description>
    <arm_group_label>Genotropin</arm_group_label>
    <other_name>Genotropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Study Inclusion Criteria:&#xD;
&#xD;
          1. Pre-pubertal children aged ≥3 years , and not yet 11 years for girls or not yet 12&#xD;
             years for boys with either isolated GHD, or GH insufficiency as part of multiple&#xD;
             pituitary hormone deficiency.&#xD;
&#xD;
          2. Confirmed diagnosis of GHD by two different GH provocation tests defined as a peak&#xD;
             plasma GH level of ≤10 ng/mL.&#xD;
&#xD;
          3. Bone age (BA) is not older than chronological age and should be less than 10 for girls&#xD;
             and less than 11 for boys.&#xD;
&#xD;
          4. Without prior exposure to any r-hGH therapy (naïve patients).&#xD;
&#xD;
          5. Impaired height and height velocity defined as:&#xD;
&#xD;
               -  Annualized height velocity (HV) below the 25th percentile for CA (HV &lt; -0.7 SDS)&#xD;
                  and gender according to sponsor calculator&#xD;
&#xD;
               -  The interval between 2 height measurements should be at least 6 months, but&#xD;
                  should not exceed 18 months prior to inclusion&#xD;
&#xD;
          6. Baseline IGF-I level of at least 1 SD below the mean IGF-1 level standardized for age&#xD;
             and sex (IGF-1 SDS ≤-1)&#xD;
&#xD;
          7. Normal calculated GFR per updated bedside Schwartz formula for pediatric patients&#xD;
&#xD;
          8. Children with multiple hormonal deficiencies must be on stable replacement therapies&#xD;
             (no change in dose) for other hypothalamo-pituitary-organ axes for at least 3 months&#xD;
             prior ICF signing&#xD;
&#xD;
          9. Normal 46XX karyotype for girls.&#xD;
&#xD;
         10. Willing and able to provide written informed consent of the parent or legal guardian&#xD;
             and written assent from patient&#xD;
&#xD;
             LT-OLE Inclusion Criteria:&#xD;
&#xD;
         11. Completion of the main study (12 months of treatment) with adequate compliance.&#xD;
&#xD;
         12. Willing and able to provide written informed consent of the parent or legal guardian&#xD;
             and written assent from patient&#xD;
&#xD;
         13. Agree to refrain from sexual activity&#xD;
&#xD;
        Main Study Exclusion Criteria:&#xD;
&#xD;
          1. Children with prior history of leukemia, lymphoma, sarcoma or any other forms of&#xD;
             cancer.&#xD;
&#xD;
          2. History of radiation therapy or chemotherapy&#xD;
&#xD;
          3. Malnourished children defined as BMI &lt; -2 SDS for age and sex&#xD;
&#xD;
          4. Children with psychosocial dwarfism&#xD;
&#xD;
          5. Children born small for gestational age (SGA - birth weight and/or birth length &lt;-2&#xD;
             SDS for gestational age)&#xD;
&#xD;
          6. Presence of anti-hGH antibodies at screening&#xD;
&#xD;
          7. Any clinically significant abnormality likely to affect growth or the ability to&#xD;
             evaluate growth, such as, but not limited to, chronic diseases like renal&#xD;
             insufficiency, spinal cord irradiation, etc.&#xD;
&#xD;
          8. T2 and T1 diabetic patients, who in the opinion of the investigator are not receiving&#xD;
             standard of care treatment or are non-compliant with their prescribed treatment or who&#xD;
             are in poor metabolic control.&#xD;
&#xD;
          9. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan&#xD;
             syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX mutations/deletions and&#xD;
             skeletal dysplasias.&#xD;
&#xD;
         10. Concomitant administration of other treatments that may have an effect on growth such&#xD;
             as anabolic steroids, or sex steroids, with the exception of ADHD drugs or hormone&#xD;
             replacement therapies (thyroxin, hydrocortisone, desmopressin)&#xD;
&#xD;
         11. Children requiring glucocorticoid therapy (e.g. for asthma) that are taking&#xD;
             chronically a dose greater than 400 μg/d of inhaled budesonide or equivalent&#xD;
&#xD;
         12. Major medical conditions and/or presence of contraindication to r-hGH treatment.&#xD;
&#xD;
         13. More than one closed epiphyses&#xD;
&#xD;
         14. Known or suspected HIV-positive patient, or patient with advanced diseases such as&#xD;
             AIDS or tuberculosis.&#xD;
&#xD;
         15. Drug, substance, or alcohol abuse.&#xD;
&#xD;
         16. Known hypersensitivity to the components of study medication.&#xD;
&#xD;
         17. Other causes of short stature such as celiac disease, uncontrolled primary&#xD;
             hypothyroidism and rickets.&#xD;
&#xD;
         18. Likely non-compliance in respect to study conduct&#xD;
&#xD;
         19. Participation in any other trial of an investigational agent within 30 days prior to&#xD;
             consent&#xD;
&#xD;
         20. Study enrollment has been met or study is closed by sponsor prior to completion of&#xD;
             screening process.&#xD;
&#xD;
             LT-OLE Exclusion Criteria:&#xD;
&#xD;
         21. Concomitant administration of other treatments that may have an effect on growth such&#xD;
             as anabolic steroids, or sex steroids, with the exception of ADHD drugs or HRT&#xD;
             (thyroxin, hydrocortisone, desmopressin)&#xD;
&#xD;
         22. Change in medical condition during the treatment period (such as, but not limited to,&#xD;
             development of a serious inter-current critical illness, a severe adverse drug&#xD;
             reaction, etc.)&#xD;
&#xD;
         23. Positive pregnancy test&#xD;
&#xD;
         24. Unresolved drug related (Genotropin or MOD-4023) SAE from the treatment period as per&#xD;
             medical monitor judgement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tony Cruz</last_name>
    <role>Study Director</role>
    <affiliation>Sponsor GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Orange County- Children's Clinic</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital- Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Pediatrics</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Health System</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Medical Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Luke's Children's Specialty Center</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusettes</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Diabetes &amp; Obesity Clinical Specialist</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goryeb Children's Hospital</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buffalo Children's Hospital</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Einstein College of Medicine at Yeshiva University</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Cincinnati / Cincinnati Center for Growth Disorders</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cook Children's Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Bridge Children's Hospital &amp; Health Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Materno Infantil San Roque</name>
      <address>
        <city>Paraná</city>
        <state>Entre Rios</state>
        <zip>3100</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Ninos de la Santisima Trinidad Cordoba</name>
      <address>
        <city>Córdoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hunter Children's Hospital</name>
      <address>
        <city>New Lambton Heights</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital at Westmead</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PM Hospital for Children</name>
      <address>
        <city>Subiaco</city>
        <state>Western Australia</state>
        <zip>6008</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Institution- 2nd City Pediatric Hospital</name>
      <address>
        <city>Minsk</city>
        <zip>220020</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Sveta Marina</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de recherche du CHU Sainte-Justine</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dexa Diab</name>
      <address>
        <city>Bogotá</city>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniendo</name>
      <address>
        <city>Bogotá</city>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe</name>
      <address>
        <city>Medellín</city>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maritime Hospital JSC</name>
      <address>
        <city>Batumi</city>
        <zip>6010</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vere XXI JSC</name>
      <address>
        <city>Tbilisi</city>
        <zip>0108</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aghia Sophia Children's Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Children's Hospital of Athens P&amp;A Kyriakou</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manipal Hospital</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>560017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Getwell Health &amp; Research Institute</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jehangir Clinical Development Centre</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Postgraduate Institute of Medical Education and Research</name>
      <address>
        <city>Chandigarh</city>
        <state>Punjab</state>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Hospital</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangna</state>
        <zip>500001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meditrina Institute of Medical Sciences</name>
      <address>
        <city>Nagpur</city>
        <zip>440010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Gangaram Hospital</name>
      <address>
        <city>New Delhi</city>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemek Medical Center</name>
      <address>
        <city>Afula</city>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center</name>
      <address>
        <city>Be'er Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Be'er Ya'aqov</city>
        <zip>7030000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnei Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3339509</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scheider Children's Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Hashomer Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Reẖovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bundang Cha Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>13497</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KyungPook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chosun University Hospital</name>
      <address>
        <city>Gwangju</city>
        <zip>61453</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Angeles de Puebla</name>
      <address>
        <city>Puebla</city>
        <state>Reserva Territorial Atilxcayotl</state>
        <zip>72190</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Liggins Institute</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Children's Hospital</name>
      <address>
        <city>Newtown</city>
        <state>Wellington</state>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne in Gdansk</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-211</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia Matki Polki</name>
      <address>
        <city>Łódź</city>
        <zip>93-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bashkirian State Medical University</name>
      <address>
        <city>Ufa</city>
        <state>Bashlortostan Republic</state>
        <zip>450008/450106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kazan State Medical Univeristy/Pediatric Republic Clinical Hospital</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan Republic</state>
        <zip>420012/420138</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrinology Scientific Center</name>
      <address>
        <city>Moscow</city>
        <zip>117036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric City Clinical Hospital/Russian Medical Academy of Continuous Education</name>
      <address>
        <city>Moscow</city>
        <zip>125373</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg State Pediatric Medical University</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194100</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Voronezh State Medical University</name>
      <address>
        <city>Voronezh</city>
        <zip>394024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <state>Aragon</state>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Josep Trueta</name>
      <address>
        <city>Girona</city>
        <state>Cataluna</state>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago De Compostela</city>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine</name>
      <address>
        <city>Kyiv</city>
        <zip>01021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Endocrinology and Metabolism/VP Komisarenko of Academy of Medical Science of Ukraine</name>
      <address>
        <city>Kyiv</city>
        <zip>04114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odesa Regional Clinical Children's Hospital</name>
      <address>
        <city>Odesa</city>
        <zip>65031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnitsa Regional Clinical Highly Specialized Endocrinology Centre</name>
      <address>
        <city>Vinnitsa</city>
        <zip>21010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zaporizhzhya Regional Clinical Child Hospital</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69063</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hospital for Children</name>
      <address>
        <city>Glasgow</city>
        <zip>G514TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George's University Hospital</name>
      <address>
        <city>London</city>
        <zip>SW17 OQT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belarus</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Georgia</country>
    <country>Greece</country>
    <country>India</country>
    <country>Israel</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
    <country>Italy</country>
    <country>Turkey</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>May 10, 2021</results_first_submitted>
  <results_first_submitted_qc>June 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 25, 2021</results_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02968004/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02968004/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MOD-4023</title>
          <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
        </group>
        <group group_id="P2">
          <title>Genotropin</title>
          <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MOD-4023</title>
          <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
        </group>
        <group group_id="B2">
          <title>Genotropin</title>
          <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="109"/>
            <count group_id="B2" value="115"/>
            <count group_id="B3" value="224"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.83" spread="2.66"/>
                    <measurement group_id="B2" value="7.61" spread="2.37"/>
                    <measurement group_id="B3" value="7.72" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiracial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Colombia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belarus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Annual Height Velocity</title>
        <description>Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.</description>
        <time_frame>52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MOD-4023</title>
            <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
          </group>
          <group group_id="O2">
            <title>Genotropin</title>
            <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Height Velocity</title>
          <description>Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.</description>
          <units>cm/year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.10" lower_limit="9.58" upper_limit="10.63"/>
                    <measurement group_id="O2" value="9.78" lower_limit="9.29" upper_limit="10.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Height Velocity at 6 Months</title>
        <description>Height velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.</description>
        <time_frame>After 6 months of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MOD-4023</title>
            <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
          </group>
          <group group_id="O2">
            <title>Genotropin</title>
            <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
          </group>
        </group_list>
        <measure>
          <title>Height Velocity at 6 Months</title>
          <description>Height velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.</description>
          <units>cm/year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.59" lower_limit="9.96" upper_limit="11.22"/>
                    <measurement group_id="O2" value="10.04" lower_limit="9.47" upper_limit="10.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Height Standard Deviation Score (SDS)</title>
        <description>Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.</description>
        <time_frame>After 6 and 12 months</time_frame>
        <population>Two subjects discontinued, one from each group.</population>
        <group_list>
          <group group_id="O1">
            <title>MOD-4023</title>
            <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
          </group>
          <group group_id="O2">
            <title>Genotropin</title>
            <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Height Standard Deviation Score (SDS)</title>
          <description>Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.</description>
          <population>Two subjects discontinued, one from each group.</population>
          <units>Standard Deviation Score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SDS at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" lower_limit="0.48" upper_limit="0.61"/>
                    <measurement group_id="O2" value="0.48" lower_limit="0.42" upper_limit="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SDS at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" lower_limit="0.82" upper_limit="1.02"/>
                    <measurement group_id="O2" value="0.87" lower_limit="0.78" upper_limit="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Bone Maturation (BM)</title>
        <description>Annual change in bone age measurements as per Gruelich-Pyle method</description>
        <time_frame>52 weeks</time_frame>
        <population>5 participants of MOD-4023 and 13 participants of Genotropin did not have bone age measurements at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>MOD-4023</title>
            <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
          </group>
          <group group_id="O2">
            <title>Genotropin</title>
            <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bone Maturation (BM)</title>
          <description>Annual change in bone age measurements as per Gruelich-Pyle method</description>
          <population>5 participants of MOD-4023 and 13 participants of Genotropin did not have bone age measurements at 12 months.</population>
          <units>ratio of bone age to chronologic age</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.09"/>
                    <measurement group_id="O2" value="0.06" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)</title>
        <description>Via central lab analysis</description>
        <time_frame>Baseline and at 12 months</time_frame>
        <population>2 subjects in MOD-4023 and 5 subjects in Genotropin didn't have the measurements at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>MOD-4023</title>
            <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
          </group>
          <group group_id="O2">
            <title>Genotropin</title>
            <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
          </group>
        </group_list>
        <measure>
          <title>Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)</title>
          <description>Via central lab analysis</description>
          <population>2 subjects in MOD-4023 and 5 subjects in Genotropin didn't have the measurements at 12 months</population>
          <units>Standard Deviation Score (SDS)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.95" spread="0.89"/>
                    <measurement group_id="O2" value="-1.72" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="1.32"/>
                    <measurement group_id="O2" value="-0.69" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Device</title>
        <description>Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA</description>
        <time_frame>6 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Device</title>
        <description>Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MOD-4023</title>
            <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
          </group>
        </group_list>
        <measure>
          <title>Device</title>
          <description>Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MOD-4023</title>
          <description>Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)&#xD;
MOD-4023: Once weekly subcutaneous injection using pre-filled pen device.</description>
        </group>
        <group group_id="E2">
          <title>Genotropin</title>
          <description>Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)&#xD;
Somatropin: Once daily subcutaneous injection of Genotropin</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Chronic tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="90" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Enterobiasis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Molluscum contagiosum</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Free fatty acids increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hypoinsulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>OPKO Health Inc</name_or_title>
      <organization>OPKO Health Inc</organization>
      <phone>3055754100</phone>
      <email>contact@opko.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02968004
org study id: CP-4-006
nct id: NCT02968004
lead sponsor: 
This will be an open-label, randomized, multicenter, efficacy and safety study of weekly
      MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone
      deficiency.
The study will consist of a 12 month, open-label, randomized, active controlled, parallel
      group study comparing the efficacy and safety of weekly MOD-4023 to daily growth hormone
      (GH), Genotropin. After 12 months, subjects will have the option to enter the long term
      open-label extension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Annual Height Velocity
time frame: 52 weeks
description: Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
measure: Height Velocity at 6 Months
time frame: After 6 months of treatment
description: Height velocity in cm measured after 6 months of treatment. Annualized Height velocity after 6 months is calculated based on the difference between the heights at 6 months and baseline.
measure: Change in Height Standard Deviation Score (SDS)
time frame: After 6 and 12 months
description: Change in height Standard Deviation Score (SDS) after 6 and 12 months is calculated based on the difference between the heights at 6 and 12 months and baseline.
measure: Change in Bone Maturation (BM)
time frame: 52 weeks
description: Annual change in bone age measurements as per Gruelich-Pyle method
measure: Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)
time frame: Baseline and at 12 months
description: Via central lab analysis
measure: Device
time frame: 6 weeks
description: Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA
measure: Device
time frame: 1 week
description: Proportion of successful single injections out of total number of single injections using the MOD-4023 Pen in the USA at Week 1 based on the Observer Assessment Tool (OAT)
arm group label: MOD-4023
arm group type: Experimental
description: Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)
arm group label: Genotropin
arm group type: Active Comparator
description: Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
intervention type: Drug
intervention name: MOD-4023
description: Once weekly subcutaneous injection using pre-filled pen device.
arm group label: MOD-4023
other name: Somatrogon
intervention type: Drug
intervention name: Somatropin
description: Once daily subcutaneous injection of Genotropin using pre-filled pen device.
arm group label: Genotropin
other name: Genotropin
criteria: 
gender: All
minimum age: 3 Years
maximum age: 11 Years
healthy volunteers: No
last name: Tony Cruz
role: Study Director
affiliation: Sponsor GmbH
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country: Argentina
country: Australia
country: Belarus
country: Bulgaria
country: Canada
country: Colombia
country: Georgia
country: Greece
country: India
country: Israel
country: Korea, Republic of
country: Mexico
country: New Zealand
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
country: Germany
country: Italy
country: Turkey
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
sharing ipd: No
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