NCT01017614已完成3 期
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Oligosaccharide (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Change in Hb concentration from baseline to week 8.
研究概览
简要总结
The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).
详细描述
The study is designed to determine the effects of an investigational drug Monofer in subjects with Inflammatory Bowel Disease (IBD) (an intestinal disease characterized by swelling, redness and sometimes ulcers in intestine) and with Iron Deficiency Anaemia (IDA) (Anaemia is a condition characterized by deficiency of blood in the body).
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
- •Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria:
- •Men and women, aged more than 18 years.
- •Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis).
- •Hb <12.0 g/dL (7.45 mmol/L).
- •Transferrin saturation (TfS) <20 %.
排除标准
- •Anaemia predominantly caused by other factors than iron deficiency anaemia.
- •Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
- •Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate).
- •Known hypersensitivity to any excipients in the investigational drug products.
- •Subjects with a history of multiple allergies.
- •Active Intestinal Tuberculosis.
- •Active Intestinal amoebic infections.
- •Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper limit normal).
- •Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive protein (CRP)).
- •Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- •Pregnancy and nursing
- •Extensive active bleeding necessitating blood transfusion.
- •Planned elective surgery during the study.
- •Participation in any other clinical study within 3 months prior to screening.
- •Intolerance to oral iron treatment.
- •Untreated B12 or folate deficiency.
- •Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
- •Erythropoetin treatment within 8 weeks prior to screening visit.
- •Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test.
- •Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
- •History of immunocompromise, including positive HIV test result
研究组 & 干预措施
Monofer
Experimental
- administered as intravenous infusions (A1)
- administered as intravenous bolus injections (A2)
干预措施: Monofer (Drug)
Iron Sulphate
Active Comparator
tablets administered orally
干预措施: Iron Sulphate (Drug)
结局指标
主要结局
Change in Hb concentration from baseline to week 8.
时间窗: 8 weeks
次要结局
- Number of subjects who achieve target limits of Hb (men 13-18 g/dL, women 12-16 g/dL) and have change in Hb concentration > 1.0 g/dL and have serum ferritin (100-800µg/L) and have achieved Transferrin saturation (TfS) (20-50 %) at week 2, 4 and 8.(8 weeks)
研究者
研究点 (1)
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