The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).
A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease. Approximately 242 eligible subjects will be randomised (1:1) to receive one of the following treatments for the duration of the study treatment period (52 weeks): * Oral ferric maltol, 30 mg capsule bid. * Intravenous iron (ferric carboxy maltose) as per SPC In the FCM arm IV iron treatment will be repeated if the subject is iron deficient at any of the study visits. Subject participation in the study will consist of 3 periods: * Screening: Up to 14 days * Randomised Treatment: 52 weeks * Post-treatment safety follow-up: 14 days after study medication discontinuation Primary efficacy and safety of ferric maltol and Intravenous iron (ferric carboxy maltose) will be evaluated after the first 12 weeks. End of study evaluations will occur at Week 52 or premature discontinuation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12
Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women,\>=13g/dL men) at Week 12
Time frame: Baseline to Week 12
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12
Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women, \>=13g/dL men) at Week 12
Time frame: Baseline to Week 12
Change in Hb Concentration From Baseline to Week 12
Change in hemoglobin concentration from baseline to Week 12.
Time frame: Baseline to Week 12
Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL
Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \<9.5 g/dL.
Time frame: Baseline to Week 12
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12
Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12.
Time frame: Baseline to Week 12
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.
Time frame: Baseline to Week 12
Number of Subjects With Hb Concentration Within Normal Limits at Week 12
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Dothan, Alabama, United States
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Tucson, Arizona, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Chevy Chase, Maryland, United States
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Saint Paul, Minnesota, United States
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St Louis, Missouri, United States
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Great Neck, New York, United States
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Lima, Ohio, United States
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Germantown, Tennessee, United States
...and 34 more locations
Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Week 12
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12
Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Week 12
Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months
Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Month 6
Change in Hb Concentration From Baseline to Week 4
Change in hemoglobin concentration from baseline to Week 4.
Time frame: Baseline to Week 4
Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL
Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \<9.5 g/dL.
Time frame: Baseline to Week 4
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12
Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.
Time frame: Baseline to Week 12
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.
Time frame: Baseline to Week 12
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4
Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.
Time frame: Baseline to Week 4
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.
Time frame: Baseline to Week 4
Number of Subjects With Hb Concentration Within Normal Limits at Week 4
Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Week 4
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4
Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Week 4
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4
Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.
Time frame: Baseline to Week 4
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4
Time frame: Baseline to Week 4