A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 主要终点
- Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12
研究概览
简要总结
The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).
详细描述
A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease.
Approximately 242 eligible subjects will be randomised (1:1) to receive one of the following treatments for the duration of the study treatment period (52 weeks):
- Oral ferric maltol, 30 mg capsule bid.
- Intravenous iron (ferric carboxy maltose) as per SPC
In the FCM arm IV iron treatment will be repeated if the subject is iron deficient at any of the study visits.
Subject participation in the study will consist of 3 periods:
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
- None
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
- 未提供
研究组 & 干预措施
Oral ferric iron compound
30 mg capsules to be taken orally twice a day for 52 weeks
干预措施: Ferric Maltol (Drug)
Intravenous iron
Administered as per the local summary of product characteristics (SPC)
干预措施: Ferric Carboxy Maltose (Drug)
结局指标
主要结局
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12
时间窗: Baseline to Week 12
Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women, \>=13g/dL men) at Week 12
次要结局
- Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL(Baseline to Week 12)
- Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months(Baseline to Month 6)
- Change in Hb Concentration From Baseline to Week 12(Baseline to Week 12)
- Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL(Baseline to Week 4)
- Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12(Baseline to Week 12)
- Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12(Baseline to Week 12)
- Change in Hb Concentration From Baseline to Week 4(Baseline to Week 4)
- Number of Subjects With Hb Concentration Within Normal Limits at Week 12(Baseline to Week 12)
- Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12(Baseline to Week 12)
- Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12(Baseline to Week 12)
- Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4(Baseline to Week 4)
- Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4(Baseline to Week 4)
- Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4(Baseline to Week 4)
- Number of Subjects With Hb Concentration Within Normal Limits at Week 4(Baseline to Week 4)
- Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12(Baseline to Week 12)
- Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4(Baseline to Week 4)
- Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4(Baseline to Week 4)