A Clinical study to assess PK properties of Intravenous iron isomaltoside with mean molecular weight of 1000 daltons by administering for 500 mg and 1000 mg doses to Inflammatory Bowel Disease
- Conditions
- Health Condition 1: null- Inflammatory Bowel Disease (IBD) with iron deficiency anemia
- Registration Number
- CTRI/2011/12/002304
- Lead Sponsor
- Pharmacosmos AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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 <12 g/dL.
5.Transferrin saturation (TfS) <20%.
6.Life expectancy beyond 12 months by investigatorâ??s judgment.
7.Willingness to participate after informed consent
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method