Phase 3Completed
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women (ASAP)
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
- Sponsor
- Vifor Pharma (Industry)
- Enrollment
- 252 enrolled
- Conditions
- Anaemia
- Interventions
- ferrous sulphate; Ferinject
- Ages
- adults, older adults
- Registry
- NCT01131624
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
History
Last registry update
Study completion
Primary completion
Registered
Started