NCT00810004已完成3 期
A Multi-centre, Randomised, Prospective, Single-blinded, Controlled Study to Investigate the Efficacy and Safety of a Standardised Maintenance Dosage Regimen of Intravenous Ferric Carboxymaltose (FERINJECT®) Versus Placebo in Patients With Iron Deficiency Caused by Inflammatory Bowel Disease
Vifor Pharma1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Efficacy of maintenance treatment of iron deficiency
研究概览
简要总结
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Chronic alcohol abuse (alcohol consumption >20 g/day).
- •Presence of portal hypertension with oesophageal varices. History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.
- •Known hypersensitivity to FERINJECT®.
- •History of acquired iron overload.
- •Myelodysplastic syndrome.
- •Pregnancy or lactation.
- •Known active infection, clinically significant overt bleeding, active malignancy. Known chronic renal failure.
- •Surgery with relevant blood loss (defined as Hb drop <2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.
- •Chronic liver disease or increase of liver enzymes (alanine aminotransferase ([ALT], aspartate aminotransferase [AST]) >3 times the upper limit of normal range.
- •Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
- •Participation in any other interventional study (except correction study) within 1 month prior to screening.
- •Body weight <35 kg.
- •Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.
研究组 & 干预措施
Ferinject
Experimental
Intravenous infusion of iron
干预措施: Ferinject (Drug)
Placebo
Placebo Comparator
NaCL 0,9%
干预措施: Ferinject (Drug)
结局指标
主要结局
Efficacy of maintenance treatment of iron deficiency
时间窗: 8 months
次要结局
未报告次要终点
研究者
研究点 (1)
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