A study of intravenous iron isomaltoside 1000 (Monofer®) compared to placebo in subjects with iron deficiency anaemia who are Intolerant or unresponsive to oral iron therapy

• Conditions: Subjects with iron deficiency anaemia (IDA) caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy.; MedDRA version: 17.1Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-001518-25-DE
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-15
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

A subject will be eligible for inclusion in the study if he/she fulfils the following criteria:
1. Men or women = 18 years having IDA caused by different aetiologies* such as ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy** for at least one month*** prior to study enrolment
2. Hb < 11 g/dL
3. TSAT < 20 %
4. S-ferritin < 100 ng/mL
5. Willingness to participate and signing the informed consent form (ICF)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

A subject will not be eligible for inclusion in this study if he/she fulfils any of the following criteria:
1. Hb < 6 g/dL
2. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
3. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
4. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
5. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
6. Body weight < 50 kg
7. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
8. History of multiple allergies
9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
10. Erythropoietin treatment within 8 weeks prior to the screening visit
11. Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit
12. Participation in any other interventional clinical study within 3 months prior to the screening visit
13. 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, e.g. uncontrolled hypertension, unstable ischaemic heart dis-ease, or uncontrolled diabetes mellitus

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified