Iron deficiency anaemia with inflammatory bowel disease MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - B
Conditions
Interventions
Trade Name: Feraccru
Product Name: Ferracru
Product Code: ST10
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ferric maltol
Sponsors
Shield TX (UK) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved informed consent form and must sign and date the informed consent prior to any study mandated procedure 2. Subjects must be willing and able to comply with study requirements 3. Age = 18 years 4. Subjects must have a confirmed diagnosis of IBD (endoscopic and/or biopsy) 5. Subjects must be considered suitable for intravenous iron treatment by the Investigator 6. Subjects must have iron deficiency anaemia defined by the following criteria: a. Hb =8.0 g/dL and =11.0 g/dL for women OR a Hb =8.0 g/dL and =12.0 g/dL for men b. AND Ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: 1. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to, a. Untreated or untreatable severe malabsorption syndrome b. 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 a. Within 8 weeks intramuscular or intravenous (IV) iron or administration of depot iron preparation b. Within 2 weeks a blood transfusion c. 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 (Simple Clinical Colitis Activity Index) score greater than 5 at Screening or a CDAI (Crohn’s Disease Activity Index) 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. Subject 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of ferric maltol and intravenous iron (FCM) in the treatment and maintenance of iron deficiency anaemia in subjects with IBD; Secondary Objective: To evaluate the safety and tolerability of ferric maltol and IVI in subjects over a treatment duration of up to 52 weeks. To evaluate long-term healthcare resources utilized in the management of IDA in IBD. ;Primary end point(s): Proportion of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (> 12g/dL women, >13g/dL men) at week 12;Timepoint(s) of evaluation of this end point: Baseline, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in Hb concentration from baseline to Week 12 - Change in Hb concentration from baseline to Week 12 in subjects with a baseline Hb <9.5 g/dL - Proportion of subjects who experience a change from baseline in Hb concentration =1.0 g/dL at Week 12 - Proportion of subjects with baseline Hb <9.5g/dL that achieve an increase in Hb concentration of =1 g/dL at Week 12 - Proportion of subjects with Hb concentration within normal limits at Week 12 - Proportion of subjects with baseline Hb concentration <9.5 g/dL that is within normal limits at Week 12 - Change in Hb concentration from baseline to Week 4 - Change in Hb concentration from baseline to Week 4 in subjects with a baseline Hb <9.5 g/dL - Proportion of subjects who experience a change from baseline in Hb concentration =2.0 g/dL at Week 12 - Proportion of subjects with baseline Hb <9.5g/dL that achieve an increase in Hb concentration of =2 g/dL at Week 12 - Proportion of subjects who experience a change from baseline in Hb concentration =1.0 g/dL at Week 4 - Proportion of subjects with baseline Hb <9.5g/dL that achieve an increase in Hb concentration of =1 g/dL at Week 4 - Proportion of subjects with Hb concentration within normal limits at Week 4 - Proportion of subjects with baseline Hb concentration <9.5 g/dL that is within normal limits at Week 4 - Proportion of subjects who experience a change from baseline in Hb concentration =2.0 g/dL at Week 4 - Proportion of subjects with baseline Hb <9.5g/dL that achieve an increase in Hb concentration of =2 g/dL at Week 4 - Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 and 12 months; normalization of ferrit | — |
Countries
Belgium, France, Germany, Hungary, Spain, United States
Contacts
Public ContactClinical Operations
Shield TX (UK) Ltd.
Outcome results
None listed