A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions to Iron-Deficient Blood Donors

Phase 1

• Conditions: Female first-time bloddonors with iron deficiency; MedDRA version: 18.1Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-001529-28-DK
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-15
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

A subject will be eligible for inclusion in the study if they fulfil the following criteria:
1.Women aged = 18 years
2.First-time donor
3.P-ferritin < 60 µg/L
4.Willingness to participate and signed the informed consent form

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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

A subject will not be eligible for inclusion in this study if they fulfil any of the following criteria:
1.Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)
2.Known hypersensitivity to any excipients in the investigational drug products
3.History of drug related allergies
4.History of severe asthma
5.Decompensated liver cirrhosis and hepatitis (defined as ALAT > 3 times upper limit of normal)
6.Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP)
7.Rheumatoid arthritis with symptoms or signs of active inflammation
8.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 adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) 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
9.Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
10.Untreated vitamin B12 or folate deficiency
11.Treated with other IV or oral iron products within 4 weeks prior to the screening
12.Treated with Erythropoietin (EPO) within 4 weeks prior to the screening

Study & Design

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