EUCTR2017-002972-15-GR进行中（未招募）1 期
Ferrous Acetyl-Aspartylated Casein Formulation Evaluation over Ferrous Sulfate in Iron Deficiency Anemia (Access): A Double-Dummy Randomized Clinical Trial - ACCESS
ni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.0 个研究点目标入组 60 人开始时间: 2017年9月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female
- •2.Age equal to or more than 18 years
- •3.Written informed consent provided by the patient
- •4.Hb below 10g/dl, as defined by other trials
- •5.Absolute red blood cell (RBC) count below 4.7 x 106/mm3 for men or 4.2 x 106/mm3 for women
- •6.Mean corpuscular volume (MCV) of RBCs below 80 fl
- •7.Mean corpuscular Hb (MCH) of RBCs below 27 pg
- •8.Total ferritin below 30 ng/ml; this criterion is associated with sensitivity more than 99% for iron deficiency
- •9.In the case of patients with anemia after GI tract hemorrhage, inclusion criteria 6 and 7 DO NOT apply for study inclusion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Age below 18 years
- •Denial to provide written informed consent
- •Acute myelogenous or lymphoblastic leukemia
- •Multiple myeloma
- •Primary or secondary myelodysplastic syndrome
- •Planning for start of chemotherapy within the first 30 days after inclusion in the trial
- •Planning for start of radiotherapy within the first 30 days after inclusion in the trial
- •Intake of erythropoietin
- •Planning for start of erythropoietin within the first 30 days after inclusion in the trial
- •Intake of chemotherapy the last six months
- •Intake of radiotherapy the last six months
- •Known hemochromatosis
- •Known celiac disease
- •Liver cirrhosis of Child-Pugh stage II or III
- •Any active overt bleeding
- •Pregnancy or lactation
研究者
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