Treatment of pregnant women with iron deficiency anemia The primary objective of the trial is to evaluate and compare the effect of IV iron isomalto-side to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction ...

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Treatment of women after severe Postpartum Haemorrhage The primary objective of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluat...

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A study of intravenous iron isomaltoside 1000 (Monofer®) compared to placebo in subjects with iron deficiency anaemia who are Intolerant or unresponsive to oral iron therapy The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparatio...

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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 To demonstrate that intravenous iron oligosaccharides is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to IBD, evaluated as the ability to increase haemoglobin (Hb).

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A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions to Iron-Deficient Blood Donors The primary efficacy objective of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo in first-time female donors with p-ferritin below 60 µg/L. The safety objecti...

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Treatment of Women after Postpartum Haemorrhage The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.

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A non-comparative open-label study of Iron Oligosaccharide in CHF patients with iron deficiency (either absolute or functional) anaemia and a need for parenteral iron The primary objective of the present study is to obtain safety reassurance with the use of Iron oligosaccharide given either as repeated IV boluses or as total dose infusion (TDI) for the correction o...

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A clinical Safety Study of the medicinal product Monofer given into a vein and administered by a High Dosing Regimen in patients with Inflammatory Bowel Disease The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron iso-maltoside 1000 in subjects with IDA secondary to IBD.

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This long-term follow-up study will assess the ability to maintain a stable haemoglobin (iron containing molecule in the blood) and safety profile of iron isomaltoside 1000 (Monofer®) in Inflammatory Bowel Disease subjects with iron deficiency anemia 1. To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb ≥ 12.0 g/dL) in subjects with Hb ≥ 12.0 g/dL at the Baseline of Ex...

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A non-comparative open-label study of Iron Oligosaccharide in Chronic Kidney Disease patients with a need for parenteral iron The primary objective of the present study is to obtain such safety reassurance with the use of Iron Oligosaccharide given either as repeated IV boluses or as total dose infusion (TDI) for correction/...

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