<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/NCT03274973</url>
  </required_header>
  <id_info>
    <org_study_id>000302</org_study_id>
    <nct_id>NCT03274973</nct_id>
  </id_info>
  <brief_title>Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome</brief_title>
  <acronym>RAZANT</acronym>
  <official_title>A Prospective Non-Interventional Study to Assess Long-term Effectiveness of Zomacton® and Factors Affecting Adherence in Patients With Growth Hormone Deficiency or Growth Retardation Due to Ullrich-Turner Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency&#xD;
      or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and&#xD;
      adherence, optionally with the aid of an electronic app or patient diary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient, delayed recruitment of participants&#xD;
  </why_stopped>
  <start_date type="Actual">May 14, 2018</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Linear growth (change in height)</measure>
    <time_frame>Over the first 12 months (month 0, 3, 6, 9 and 12)</time_frame>
    <description>Change in height defined as the change of the standard deviation score of body height vs. baseline</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Growth Disorders</condition>
  <arm_group>
    <arm_group_label>Zomacton</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zomacton</intervention_name>
    <description>Injection</description>
    <arm_group_label>Zomacton</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric outpatient clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (&lt; 18 years) with growth hormone deficiency or growth retardation&#xD;
             due to Ullrich-Turner-Syndrome&#xD;
&#xD;
          -  Patients already receiving or who have been prescribed Zomacton® de novo according to&#xD;
             its German label; the decision to prescribe Zomacton® was made independently from&#xD;
             participation and prior to enrollment in this study.&#xD;
&#xD;
          -  Patient and their parents (or legal representatives) who are willing and able to&#xD;
             provide signed informed consent for use of their personal data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in an interventional clinical study within the last 30 days prior to&#xD;
             baseline visit or during the follow-up period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Compliance</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik fuer Allgemeine Paediatrie der Christian-Albrechts-Universitaet zu Kiel (there might be other sites in this country)</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</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>Turner Syndrome</mesh_term>
    <mesh_term>Gonadal Dysgenesis</mesh_term>
    <mesh_term>Growth Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274973
org study id: 000302
nct id: NCT03274973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Assessment of long-term effectiveness of ZOMACTON in treatment of Growth Hormone Deficiency
      or growth retardation due to Ullrich-Turner Syndrome and assessment of compliance and
      adherence, optionally with the aid of an electronic app or patient diary.
observational model: Cohort
time perspective: Prospective
measure: Linear growth (change in height)
time frame: Over the first 12 months (month 0, 3, 6, 9 and 12)
description: Change in height defined as the change of the standard deviation score of body height vs. baseline
arm group label: Zomacton
intervention type: Drug
intervention name: Zomacton
description: Injection
arm group label: Zomacton
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Global Clinical Compliance
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Turner Syndrome
mesh term: Gonadal Dysgenesis
mesh term: Growth Disorders