Iron Deficiency Anaemia Clinical Trial
Official title:
A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE)
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
IDA is highly prevalent in subjects with gastrointestinal diseases and cancer, menstruating
or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a
substantial medical and quality of life (QoL) burden on the subjects and the treatment of
these subjects includes controlling the bleeding and replenishing lost iron. Oral iron
administration is often used in the clinical practice at many clinics; however, oral iron may
not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in
subjects, who do not tolerate oral iron.
This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with
another parenteral iron preparation (iron sucrose) in subjects with IDA and who are
intolerant or unresponsive to oral iron therapy or who need iron rapidly.
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