WithdrawnPhase 3

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

Stopped: Study design not adequate

United States0

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Hb \< 11 g/dL
✓. TSAT \< 20 %
✓. S-ferritin \< 100 ng/mL
✓. Willingness to participate and signing the informed consent form (ICF)

Exclusion criteria

✕. Hb \< 6 g/dL
✕. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
✕. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and hae-mosiderosis)
✕. Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal)
✕. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
✕. Body weight \< 50 kg
✕. 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
✕. History of multiple allergies

What they're measuring

Proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5

Timeframe: Week 1 to 5

Trial details

NCT IDNCT02172001

SponsorPharmacosmos A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

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