A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

Criteria

Inclusion 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)

Exclusion 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 hae-mosiderosis)

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

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 ischemic heart disease, or uncontrolled diabetes mellitus