CTRI/2023/01/048725尚未招募3 期
A phase III, randomised, single blind, comparative safety, efficacy and cost effectiveness trial of intravenous iron isomaltoside (i3R) and Ferric Carboxy Maltose (FeriumR) in subjects with iron deficiency anemia - SCIFI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects having IDA are caused by nutritional and different aetiologies of blood loss such as abnormal uterine bleeding, gastrointestinal diseases, and bariatric procedures (gastric bypass operations.
- •2. Subjects with intolerance to oral iron
- •3. Hb <= 11 g/dL
- •4. TSAT < 20 %
- •5. S-ferritin < 100 ng/mL
- •6. Willingness to participate and sign the informed consent form
排除标准
- •1. Known hypersensitivity reaction to any component of iron isomaltoside or FCM
- •2. Previous serious hypersensitivity reactions to any IV iron compounds
- •3. Previously randomized in a clinical trial with iron isomaltoside
- •4, Received an investigational drug within 30 days of screening
- •5. During the 10 days before screening; has been treated with IV iron
- •6. Erythropoiesis stimulating agent (ESA) treatment within 30 days before the screening visit
- •7. During the 30 days before screening or during the trial period; has or will require a surgical procedure that necessitates general anesthesia
- •8. Any non-viral infection
- •9. Required dialysis for treatment of CKD
- •10. Any other laboratory abnormality, medical condition, or psychiatric disorder which, in the opinion of the investigator, will put the subjectâ??s disease management at risk or may result in the subject being unable to comply with the trial requirements
研究者
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