Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
The study is a prospective, non-controlled, open-label multi-centre pilot safety study of
iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory
Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two
treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will
receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion,
whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV
iron isomaltoside 1000 divided into two administrations.