Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
NCT ID: NCT02680756
Last Updated: 2020-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2016-01-31
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral ferric iron compound
30 mg capsules to be taken orally twice a day for 52 weeks
Ferric Maltol
Intravenous iron
Administered as per the local summary of product characteristics (SPC)
Ferric Carboxy Maltose
Interventions
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Ferric Maltol
Ferric Carboxy Maltose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Untreated or untreatable severe malabsorption syndrome
2. Immunosuppressant use. Immunosuppressants are permitted so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis.
Variations to dosing are permitted at the discretion of the investigator so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis
2. Subject who has received prior to screening:
1. Within 8 weeks intramuscular or intravenous (IV) iron or administration of depot iron preparation
2. Within 2 weeks a blood transfusion
3. Oral iron supplementation, taken specifically to treat anaemia, within the previous 4 weeks (Over the Counter (OTC) multivitamins containing iron are permitted)
3. Subjects with active inflammatory bowel disease as defined by a SCCAI score greater than 5 at Screening or a CDAI score greater than 300 in the Screening period (as assessed using the Screening haematocrit (HCT) and CDAI diary card completed by the subject for 7 days prior to planned randomization).
4. Subjects with known hypersensitivity or allergy to either the active substance or excipients of ferric maltol capsules or ferric carboxymaltose solution for IV administration
5. Subjects who have had serious adverse reactions to previous doses of ferric carboxymaltose or any other intravenous iron.
6. Subjects with contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia.
7. Subjects with vitamin B12 or folic acid deficiency as determined by the central laboratory screening results. Subjects may start vitamin B12 or folate replacement and rescreen after at least 2 weeks.
8. Subjects who are pregnant or breast feeding.
9. Concomitant medical conditions with significant active bleeding likely to initiate or prolong anaemia.
10. Participation in any other interventional clinical study within 30 days prior to screening.
11. Subject with cardiovascular, liver, renal, haematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject or severely limit the lifespan of the subject (i.e. unlikely to complete the full duration of the study).
12. Subject with significant neurologic or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results (e.g., Alzheimer's disease, schizophrenia or other psychosis, active or current alcohol or drug abuse)
13. Subject who is an inmate of a psychiatric ward, prison, or other state institution.
14. Subject who is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study.
15. Subjects with severe renal impairment: creatinine clearance \<30 mL/min. (Applicable to US sites Only)
18 Years
ALL
No
Sponsors
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Shield Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jackie Mitchell, PhD
Role: STUDY_DIRECTOR
Shield Therapeutics
Locations
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Dothan, Alabama, United States
Tucson, Arizona, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Chevy Chase, Maryland, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Great Neck, New York, United States
Lima, Ohio, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Beaumont, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Bountiful, Utah, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Ghent, , Belgium
Clichy, , France
Lille, , France
Lyon, , France
Saint-Etienne, , France
Salouël, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Dresden, , Germany
Hamburg, , Germany
Herne, , Germany
Jena, , Germany
Leipzig, , Germany
Lübeck, , Germany
Lüneburg, , Germany
Minden, , Germany
Oldenburg, , Germany
Schweinfurt, , Germany
Budapest, , Hungary
Miskolc, , Hungary
Szeged, , Hungary
Barcelona, , Spain
Córdoba, , Spain
Girona, , Spain
Madrid, , Spain
Santiago de Compostela, , Spain
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ST10-01-304
Identifier Type: -
Identifier Source: org_study_id