Inflammatory Bowel Disease
Conditions
Keywords
IBD, IDA, Subjects, diagnosis
Brief summary
The study is a prospective, non-controlled, open-label multi-centre pilot safety study of iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion, whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into two administrations.
Detailed description
Subjects with a diagnosis of IBD (Crohn's disease or ulcerative colitis) and IDA ( Iron Deficiency Anaemia) with or without concomi-tant inflammation will be enrolled to receive a high dose of IV iron isomaltoside 1000.
Interventions
1500-3000mg IV depending on HB level, sex and body weight
Sponsors
Pharmacosmos A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with age ≥ 18 years 2. Subjects diagnosed with IBD either in remission or active 3. Hb \< 12 g/dL for women and Hb \< 13 g/dL for men 4. Subjects with a CRP above upper limit of normality must have a ferritin below 100 µg/L, whereas subjects with a CRP below or equal to upper limit of normality must have a ferritin below 30 µg/L 5. Willingness to participate after signing informed consent
Exclusion criteria
1. Patient judged by the physician to be in need of surgery due to Crohn´s disease or ulcerative colitis within the next 2 months 2. Anaemia predominantly caused by factors other than IDA 3. Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 4. Known hypersensitivity to any excipients of iron isomaltoside 1000 5. History of multiple allergies 6. Decompensated liver cirrhosis and/or known chronic viral hepatitis (defined as Alanine Aminotransferase (ALAT) \> 3 times upper limit of normal) 7. Acute and/or chronic infections 8. Body weight \< 50 kg 9. Rheumatoid arthritis with symptoms or signs of active joint inflammation 10. Pregnancy and nursing. In order to avoid pregnancy, women have to be postmenopausal, surgically sterile, or use one of the following contraceptives during the whole study period and 5 days after the study has ended (i.e. 5 times plasma biological half-life of the investigational medicinal product): intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release) 11. Blood transfusion within the previous 12 weeks 12. Subjects with a history of asthma, allergic eczema, or other atopic allergy 13. Planned elective surgery during the study 14. Untreated Vitamin B12 or folate deficiency, defined as values below the lower reference range 15. Participation in any other clinical study within 3 months prior to Screening 16. IV iron treatment within 8 weeks prior to Screening 17. Oral iron treatment within 1 week prior to Screening 18. Erythropoiesis Stimulating Agent (ESA) treatment within 8 weeks prior to Screening 19. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron isomaltoside 1000 in subjects with IDA secondary to IBD. | up to 16 weeks | type and incidence of adverse drug reactions (ADRs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000 | up to 16 weeks | obtain a target Hb (≥ 13 g/dL in men and ≥ 12g/dL in women) |
Countries
Denmark
Outcome results
None listed