Health Condition 1: null- Inflammatory Bowel Disease (IBD) with iron deficiency anemia
Conditions
Interventions
Intervention1: Iron isomaltoside 1000 (Monofer®): Administered as 500 mg intravenous bolus injections
Frequency :- Once
Duration:- Once in study
Intervention2: Iron isomaltoside 1000 (Monofer®): Ad
Sponsors
Pharmacosmos AS
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women, aged more than 18 years. 2. Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohnâ??s disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis). 3. Weight above 50 kg. 4. Hb 5. Transferrin saturation (TfS) 6. Life expectancy beyond 12 months by investigatorâ??s judgment. 7. Willingness to participate after informed consent
Exclusion criteria
Exclusion criteria: 1. Anaemia predominantly caused by factors other than iron deficiency anaemia. 2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis). 3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes). 4. Known hypersensitivity to any excipients in the investigational drug products. 5. Subjects with a history of multiple allergies. 6. Active Intestinal Tuberculosis. 7. Active intestinal amoebic infections. 8. Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit). 9. History of immunocompromise and/or history of Hepatitis B and/or C. 10. Active acute or chronic infections [assessed by clinical judgement and if deemed necessary by investigator, supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)]. 11. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 12. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life (5 days) of the investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches). 13. Extensive active bleeding necessitating blood transfusion 14. Planned elective surgery during the study 15. Participation in any other clinical study within 3 months prior to screening 16. Untreated Vitamin B12 or folate deficiency 17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit 18. Erythropoietin treatment within 4 weeks prior to screening visit 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. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess PK properties of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer®) in IBDTimepoint: Total serum iron pharmacokinetic parameters: AUC0-t, AUC, Cmax, tmax, Ke, and t1/2 at 30 minutes and 0 minutes predose, and at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess other laboratory measures of iron statusTimepoint: Concentration of haemoglobin (Hb), serum ferritin, Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TfS) at 0 minutes predose, and at 4 hours, 8 hours, 24 hours, 48 hours and 72 hours post dose;To establish the effect of iron isomaltoside 1000 (Monofer®) on the reticulocyte countTimepoint: Change in reticulocyte count from study drug administration to 8, 24, 48 and 72 hours;To establish whether any excretion takes place in the urine after intravenous administration of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer®)Timepoint: Total urine-iron PK variables sampled accumulatively during four time intervals following each dosing event: 0-8h, 8-24h, 24-48h, and 48-72h;To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®)Timepoint: Adverse events, laboratory safety variables, physical examination, vital signs, and electrocardiogram (ECG) | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed