EUCTR2014-000246-30-DE进行中（未招募）1 期
Intravenous ferric carboxymaltose vs. oral iron substitution in patients with metastatic colorectal cancer (CRC) and iron deficiency anemia: a randomized multicenter treatment optimization study. - FERINJECT
IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest gGmbH0 个研究点目标入组 64 人开始时间: 2014年6月16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
- 64
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. Metastatic or inoperable colorectal carcinoma. No curative therapy available.
- •2. Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study.
- •3. Iron deficiency anemia: hemoglobin = 10.5 g/dl and transferrin saturation < 20 % and/or serum ferritin < 20 ng/ml
- •4. Male and female patients aged = 18 years; maturity
- •5. ECOG = 2
- •6. Written informed consent
- •7. Life expectancy > 6 months
- •8. Body weight = 40 kg
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1. Oral or intravenous iron substitution within the last 4 weeks
- •2. Age < 18 years or body weight < 40 kg
- •3. Absorption dysfunction due to short bowel syndrome or after gastric resection
- •4. Therapy with recombinant erythropoietin within the last 4 weeks
- •5. Chronic diarrhea
- •6. Chronic inflammatory bowel disease
- •7. Ferritin > 800 mg/dl at baseline
- •8. Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex
- •9. Known vitamin B12 or folic acid anemia
- •10. Necessary total parenteral nutrition
- •11. Participation in another interventional study
- •12. Pregnancy or lactation
研究者
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