Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks
studies there is a need to follow-up on long term safety and efficacy of any maintenance iron
therapy.
This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron isomaltoside
1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000 (Monofer®) and its
ability to maintain stable haemoglobin in IBD subjects with Iron Deficiency Anaemia (IDA).