NCT01428843终止3 期
A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives18 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年1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
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- Level of hemoglobin
研究概览
简要总结
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.
Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.
The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of 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
- Double (Participant, Investigator)
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
- •Age greater than 18 years
- •Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria
- •Under anti-TNF therapy or indication for starting an anti-TNF therapy
- •Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman)
- •Iron deficiency anemia defined as:
- •Ferritinemia under 100 if C-Reactive Protein under normal value OR - Ferritinemia between 30 and 100 if C-Reactive Protein above normal value
排除标准
- 未提供
研究组 & 干预措施
Ferrisat
Active Comparator
Infusion of Ferrisat (50mg/ml) at inclusion under usual practices
干预措施: FERRISAT (Drug)
Placebo
Placebo Comparator
Infusion of placebo at inclusion visit
干预措施: PLACEBO (Drug)
结局指标
主要结局
Level of hemoglobin
时间窗: 6 weeks after inclusion
Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)
次要结局
- Improvement of quality of life(6 weeks after perfusion)
- Tolerance of Ferrisat(At Inclusion)
研究者
研究点 (18)
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