Status:
COMPLETED
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors
Lead Sponsor:
Pharmacosmos A/S
Collaborating Sponsors:
Max Neeman
Conditions:
Iron-deficiency
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L
Detailed Description
At present, clinical efficacy and safety data is available for iron isomaltoside 1000 administered to patients with IDA requiring iron therapy. However, there is a need for clinical efficacy and safet...
Eligibility Criteria
Inclusion
- Women aged ≥ 18 years
- First-time donor
- P-ferritin \< 30 µg/L
- Willingness to participate and signed the informed consent form
Exclusion
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to any excipients in the investigational drug products
- History of drug related allergies
- History of severe asthma
- Decompensated liver cirrhosis and hepatitis (defined as 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))
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Subjects who are pregnant or nursing. In order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or 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: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, vaginal devices, or hormonal injections with prolonged release)
- Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
- Untreated vitamin B12 or folate deficiency
- Treated with other IV or oral iron products within 4 weeks prior to the screening
- Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
- Any other medical condition that, in the opinion of the 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01895231
Start Date
June 1 2013
End Date
December 1 2016
Last Update
March 15 2018
Active Locations (1)
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1
Copenhagen, Denmark