NCT03276910Unknown1 期
Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
Association Athletes For Transparency0 个研究点目标入组 24 人开始时间: 2017年9月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 主要终点
- Erythroferrone
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Man between 18 and 49 years old
- •Beneficiary of a social protection scheme
- •Able to sign informed consent
排除标准
- •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.
研究组 & 干预措施
Eprex 20 UI/kg
Experimental
6 doses at 20 IU/kg in subcutaneous use
干预措施: EPREX (Drug)
Eprex 50 UI/kg
Experimental
6 doses at 50 IU/kg in subcutaneous use
干预措施: EPREX (Drug)
Placebo
Placebo Comparator
6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%
干预措施: sodium chloride AGUETTANT 0.9% (Drug)
结局指标
主要结局
Erythroferrone
时间窗: 12 measures in 29 days
dosage Erythroferrone from blood samples
次要结局
- Hbmass(2 measures in 29 days)
研究者
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