<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/NCT03303573</url>
  </required_header>
  <id_info>
    <org_study_id>Multiple EPO</org_study_id>
    <nct_id>NCT03303573</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Multiple EPO Injections in Children With Cerebral Palsy</brief_title>
  <official_title>Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bundang CHA Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bundang CHA Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a retrospective review on the safety and efficacy of repetitive erythropoietin&#xD;
      injection in children with cerebral palsy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth,&#xD;
      involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown&#xD;
      neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic&#xD;
      pathways. The safety and feasibility of EPO in children were proven in previous clinical&#xD;
      trials. In addition, the efficacy of EPO is actively being investigated and some reports have&#xD;
      shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple&#xD;
      injections with expected effect, retrospective review on medical records was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>interview was performed at an average of 1 year after the completion of rhEPO injections</time_frame>
    <description>telephone interview was conducted to collect information of adverse events from all patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Gross Motor Function Measure</measure>
    <time_frame>The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared</time_frame>
    <description>The change of GMFM score before and after rhEPO injections</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">164</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>recombinant human erythropoietin group</arm_group_label>
    <description>cerebral palsy patients who had received erythropoietin from January 2013 to November 2016</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>recombinant human erythropoietin</intervention_name>
    <description>Subcutaneous rhEPO injection</description>
    <arm_group_label>recombinant human erythropoietin group</arm_group_label>
    <other_name>rhEPO</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children diagnosed with cerebral palsy who had received recombinant human erythropoietin&#xD;
        more than once.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,&#xD;
&#xD;
          -  less than 18 years of age,&#xD;
&#xD;
          -  received recombinant human erythropoietin (rhEPO) more than once.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not responding to phone interview or&#xD;
&#xD;
          -  no functional assessments available.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 7, 2017</last_update_submitted>
  <last_update_submitted_qc>October 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bundang CHA Hospital</investigator_affiliation>
    <investigator_full_name>MinYoung Kim, M.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Erythropoeitin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03303573
org study id: Multiple EPO
nct id: NCT03303573
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a retrospective review on the safety and efficacy of repetitive erythropoietin
      injection in children with cerebral palsy
Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth,
      involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown
      neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic
      pathways. The safety and feasibility of EPO in children were proven in previous clinical
      trials. In addition, the efficacy of EPO is actively being investigated and some reports have
      shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple
      injections with expected effect, retrospective review on medical records was performed.
observational model: Cohort
time perspective: Retrospective
measure: Adverse events
time frame: interview was performed at an average of 1 year after the completion of rhEPO injections
description: telephone interview was conducted to collect information of adverse events from all patients.
measure: Change of Gross Motor Function Measure
time frame: The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared
description: The change of GMFM score before and after rhEPO injections
arm group label: recombinant human erythropoietin group
description: cerebral palsy patients who had received erythropoietin from January 2013 to November 2016
intervention type: Drug
intervention name: recombinant human erythropoietin
description: Subcutaneous rhEPO injection
arm group label: recombinant human erythropoietin group
other name: rhEPO
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Bundang CHA Hospital
investigator full name: MinYoung Kim, M.D.
investigator title: Professor
mesh term: Cerebral Palsy
mesh term: Epoetin Alfa
sharing ipd: Undecided