Trial | NCT03276910  Report issue

Official Title

Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    24
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).
Study Started
Sep 08
2017
Anticipated
Primary Completion
Dec 22
2017
Anticipated
Study Completion
Jun 01
2018
Anticipated
Last Update
Sep 08
2017

Drug EPREX

6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use

Drug sodium chloride AGUETTANT 0.9%

6 injections at 1ml in subcutaneous use

Eprex 20 UI/kg Experimental

6 doses at 20 IU/kg in subcutaneous use

Eprex 50 UI/kg Experimental

6 doses at 50 IU/kg in subcutaneous use

Placebo Placebo Comparator

6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%

Criteria 

Inclusion Criteria:

Man between 18 and 49 years old
Beneficiary of a social protection scheme
Able to sign informed consent

Exclusion Criteria:

Hematocrite>50% or Hemoglobin> 17d/dl or Ferritin<30 ug/l
Hypersensitivity to the active substance or to any of the excipients ofEPREX
Erythroblastopenia already reported following treatment with erythropoietin
Uncontrolled hypertension
Any medication taken as part of a chronic treatment
Absence of stable or evolutionary pathology without treatment
History of convulsion or epilepsy
History of thrombotic vascular events
Large blood loss due to an accident, pathological condition or other similar situation.
Donation of blood or blood transfusion within three months prior to inclusion in the protocol.
No Results Posted