<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/NCT03276910</url>
  </required_header>
  <id_info>
    <org_study_id>Athletes For Transparency</org_study_id>
    <nct_id>NCT03276910</nct_id>
  </id_info>
  <brief_title>Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents</brief_title>
  <acronym>ERYTHROFER-01</acronym>
  <official_title>Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Athletes For Transparency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Milan School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre d'Investigation Clinique Lyon (CIC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ecole Nationale de Ski et d'Alpinisme (ENSA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Partnership for Clean Competition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association Athletes For Transparency</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>
      The main objective of this research is to demonstrate the possible use of erythroferrone&#xD;
      (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included&#xD;
      in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 8, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 22, 2017</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>3 different conditions:&#xD;
Eprex 20 UI/kg&#xD;
Eprex 50 UI/kg&#xD;
Placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Erythroferrone</measure>
    <time_frame>12 measures in 29 days</time_frame>
    <description>dosage Erythroferrone from blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hbmass</measure>
    <time_frame>2 measures in 29 days</time_frame>
    <description>Measure of the total mass of hemoglobin</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Sports Drug Abuse</condition>
  <arm_group>
    <arm_group_label>Eprex 20 UI/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 doses at 20 IU/kg in subcutaneous use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eprex 50 UI/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 doses at 50 IU/kg in subcutaneous use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EPREX</intervention_name>
    <description>6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use</description>
    <arm_group_label>Eprex 20 UI/kg</arm_group_label>
    <arm_group_label>Eprex 50 UI/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sodium chloride AGUETTANT 0.9%</intervention_name>
    <description>6 injections at 1ml in subcutaneous use</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man between 18 and 49 years old&#xD;
&#xD;
          -  Beneficiary of a social protection scheme&#xD;
&#xD;
          -  Able to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hematocrite&gt;50% or Hemoglobin&gt; 17d/dl or Ferritin&lt;30 ug/l&#xD;
&#xD;
          -  Hypersensitivity to the active substance or to any of the excipients ofEPREX&#xD;
&#xD;
          -  Erythroblastopenia already reported following treatment with erythropoietin&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Any medication taken as part of a chronic treatment&#xD;
&#xD;
          -  Absence of stable or evolutionary pathology without treatment&#xD;
&#xD;
          -  History of convulsion or epilepsy&#xD;
&#xD;
          -  History of thrombotic vascular events&#xD;
&#xD;
          -  Large blood loss due to an accident, pathological condition or other similar&#xD;
             situation.&#xD;
&#xD;
          -  Donation of blood or blood transfusion within three months prior to inclusion in the&#xD;
             protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine MD CORNU, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre d'Investigation Clinique (CIC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pierre SALLET, phD</last_name>
    <phone>+33661587265</phone>
    <email>p.sallet@athletesfortransparency.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Catherine MD CORNU, phD</last_name>
    <phone>+33472357231</phone>
    <email>catherine.cornu@chu-lyon.fr</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>antidoping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_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/NCT03276910
org study id: Athletes For Transparency
nct id: NCT03276910
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this research is to demonstrate the possible use of erythroferrone
      (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included
      in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 different conditions:
Eprex 20 UI/kg
Eprex 50 UI/kg
Placebo
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Erythroferrone
time frame: 12 measures in 29 days
description: dosage Erythroferrone from blood samples
measure: Hbmass
time frame: 2 measures in 29 days
description: Measure of the total mass of hemoglobin
arm group label: Eprex 20 UI/kg
arm group type: Experimental
description: 6 doses at 20 IU/kg in subcutaneous use
arm group label: Eprex 50 UI/kg
arm group type: Experimental
description: 6 doses at 50 IU/kg in subcutaneous use
arm group label: Placebo
arm group type: Placebo Comparator
description: 6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%
intervention type: Drug
intervention name: EPREX
description: 6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
arm group label: Eprex 20 UI/kg
arm group label: Eprex 50 UI/kg
intervention type: Drug
intervention name: sodium chloride AGUETTANT 0.9%
description: 6 injections at 1ml in subcutaneous use
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine MD CORNU, phD
role: Principal Investigator
affiliation: Centre d'Investigation Clinique (CIC)
last name: Pierre SALLET, phD
phone: +33661587265
email: p.sallet@athletesfortransparency.com
last name: Catherine MD CORNU, phD
phone: +33472357231
email: catherine.cornu@chu-lyon.fr
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: Undecided