EUCTR2014-001518-25-DE进行中（未招募）不适用
A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) against Placebo in Subjects with Iron Deficiency Anaemia and who are Intolerant or Unresponsive to Oral Iron Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •A subject will be eligible for inclusion in the study if he/she fulfils the following criteria:
- •1. Men or women = 18 years having IDA caused by different aetiologies* such as ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy** for at least one month*** prior to study enrolment
- •2. Hb < 11 g/dL
- •3. TSAT < 20 %
- •4. S-ferritin < 100 ng/mL
- •5. Willingness to participate and signing the informed consent form (ICF)
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •A subject will not be eligible for inclusion in this study if he/she fulfils any of the following criteria:
- •1. Hb < 6 g/dL
- •2. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
- •3. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- •4. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
- •5. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
- •6. Body weight < 50 kg
- •7. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
- •8. History of multiple allergies
- •9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- •10. Erythropoietin treatment within 8 weeks prior to the screening visit
- •11. Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit
- •12. Participation in any other interventional clinical study within 3 months prior to the screening visit
- •13. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischaemic heart dis-ease, or uncontrolled diabetes mellitus
研究者
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