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More info
You can access this
clinical trial
if you have
Inflammatory Bowel Disease
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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.

Provided treatments

  • Drug: Iron Isomaltoside 1000
Tris trial is registered with FDA with number: NCT01599702. The sponsor of the trial is Pharmacosmos A/S and it is looking for 21 volunteers for the current phase.
Official trial title:
A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease (PROMISE)