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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
* administered as intravenous infusions (A1)repeated weekly until total iron repletion is obtained * administered as intravenous bolus injections (A2)as repeated bolus injections weekly until total iron repletion is obtained
200 mg daily
Research Site
Aalborg, Denmark
Research Site
Aarhus, Denmark
Research Site
Copenhagen, Denmark
Research Site
Hyderabad, India
Change in Hb concentration from baseline to week 8.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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Research Site
Jaipur, India
Research Site
Mumbai, India
Research Site
Nashik, India
Research Site
New Delhi, India
Research Site
Pune, India
Research Site
London, United Kingdom