Anaemia Clinical Trial
Official title:
An Open-label, Multicentre, Randomised, 2-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Pregnant Women
The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.
This is an open-label, multicentre, randomised, 2-arm study to assess the efficacy and
safety of FCM compared to oral iron in pregnant women with IDA.
During the screening period (Days -10 to 0 before randomisation), subjects will be selected
based on eligibility criteria. Subjects who meet all of the inclusion criteria and none of
the exclusion criteria will undergo baseline assessments at baseline (Day 0) prior to the
first dose of study medication.
Subjects will be randomised to receive either intravenous (IV) iron (FCM, 1,000-1,500 mg) or
oral iron (ferrous sulphate, 100 mg iron twice a day; total dose 200 mg/day).
The treatment period will begin with the infusion of FCM or the intake of oral iron on Day
0.
All subjects will return for assessment of efficacy and safety at Weeks 3, 6, 9, 12 and at
delivery (or whichever comes first).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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