Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease

Official Title
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Open-label Pharmakokinetic Study of Iron Isomaltoside 1000 (Monofer)Administered by 500 mg IV Injection or 1000 mg Intravenous Infusion to Patients With Inflammatory Bowel Disease (PK-IBD-02)

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Monofer (iron isomaltoside 1000)
* Drug: Monofer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, aged more than 18 years 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 Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis) Weight above 50 kg Hb <12 g/dL (7.45 mmol/L) Transferrin saturation (TfS) <20% Life expectancy beyond 12 months by investigator's judgment Willingness to participate after informed consent - Exclusion Criteria: Anaemia predominantly caused by other factors than iron deficiency anaemia Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate) Known hypersensitivity to any excipients in the investigational drug products Subjects with a history of multiple allergies Active Intestinal Tuberculosis Active intestinal amoebic infections Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) > 3 times upper limit normal) History of immunocompromise and/or history of Hepatitis B and/or C Acute infections (assessed by clinical judgment), supported by white blood cells (WBC) and C-reactive protein (CRP)) Rheumatoid arthritis with symptoms or signs of active joint inflammation 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 of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches) Extensive active bleeding necessitating blood transfusion Planned elective surgery during the study Participation in any other clinical study within 3 months prior to screening Untreated B12 or folate deficiency Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit Erythropoietin treatment within 4 weeks prior to screening visit Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example: Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1000 mg iron isomaltoside as intravenous infusion<br> | Drug: Monofer (iron isomaltoside 1000)<br>* 1000 mg iron isomaltoside administered as a infusion over 15 minutes<br>|
| Active Comparator: 500 mg iron isomaltoside 1000 as bolus injection<br> | Drug: Monofer<br>* 500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum iron pharmakokinetic parameters |  | 24, 48 and72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total urine-iron pharmakokinetic parameters |  | 24, 48 and 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, IBD