Inflammatory Bowel Disease (IBD) MedDRA version: 16.1 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000004851
Conditions
Interventions
Trade Name: MonoFer
Pharmaceutical Form: Solution for injection/infusion
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with age = 18 years 2. Subjects diagnosed with IBD either in remission or active 3. Hb =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 or active 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. 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 |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron iso-maltoside 1000 in subjects with IDA secondary to IBD.;Secondary Objective: The secondary objectives of the study are: • To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000 • To evaluate QoL and pharmacoeconomic parameters of a high IV iron dosing regimen of iron isomaltoside 1000. In addition, the effect of iron isomaltoside 1000 on disease activity and FGF23 will be evaluated. However, these analyses will be purely exploratory. ;Primary end point(s): The primary endpoint of the study is the type and incidence of adverse drug reactions (ADRs).;Timepoint(s) of evaluation of this end point: Week 1 to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary safety endpoints are: 1. Number of adverse events (AEs) of special interest (i.e. hypersensitivity reactions or hypotension at pre-specified time points in relation to administration of study drug) 2. Change in complete blood count, s-sodium, s-potassium, s-calcium, s-phosphate, s-urea, s-creatinine, s-albumin, s-bilirubin, ASAT, and ALAT from Baseline to Week 1, 4, 8 in Treatment Group A and B or in Week 9, 12, 16 in Treatment Group B 3. Change in vital signs (pulse and blood pressure) from Baseline to Week 1, 4, 8 in Treatment Group A and B and to Week 9, 12, 16 in Treatment Group B 4. Change in electrocardiogram (ECG) from Baseline to Week 8 in Treatment Group A and to Week 16 in Treatment Group B 5. Change in weight from Baseline to Week 8 in Treatment Group A and to Week 16 in Treatment Group B 6. Change in physical condition from Screening to Week 8 in Treatment Group A and to Week 16 in Treatment Group B The secondary efficacy endpoints are: 1. Number of subjects who obtain a target Hb (= 13 g/dL in men and = 12g/dL in women) at Week 1, 4, 8 in Treatment Group A and B and at Week 9, 12, 16 in Treatment Group B 2. Number of subjects who have an increase in Hb concentration = 2.0 g/dL from Baseline to Week 8 in Treatment Group A and B or to Week 16 in Treatment Group B 3. Number of subjects who have an increase in Hb concentration = 1.0 g/dL from Baseline to Week 8 in Treatment Group A and B or to Week 16 in Treatment Group B 4. Time to obtain an increase in Hb concentration =1.0 g/dL or = 2.0 g/dL 5. Change in Hb concentration from Baseline to Week 1, 4, 8 in Treatment Group A and B and to Week 9, 12, 16 in Treatment Group B 6. Change in concentrations of s-iron, s-ferritin, transferrin, TfS, reticulocytes, reticulocyte haemo-globin content (CHr), and soluble transferrin receptor (sTfR) from Baseline to Week 1, 4, 8 in Treatment Group A and B and to Week 9, 12, 16 in Treatment Group B 7. Change in QoL sco | — |
Countries
Denmark, Netherlands, Sweden
Contacts
Public ContactCMO
Pharmacosmos A/S
Outcome results
None listed