Iron Deficiency Anemia Clinical Trial
Official title:
A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo in Subjects With Iron Deficiency Anaemia and Who Are Intol-erant 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 preparations are ineffective or cannot be used.
IDA is highly prevalent in subjects and can have a substantial medical and quality of life
(QoL) burden on the subjects and the treatment of these subjects includes 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
placebo in subjects with IDA and who are intolerant or unresponsive to oral iron therapy..
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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