E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with anaemia and who have a need for parenteral iron due to either absolute or functional iron deficiency anaemia will be included. Patients may receive concomitant Erythropoeisis Stimulating Agents treatment according to hospital standards but this is not a requirement for participation. Patients previous treated with parenteral iron therapy but still needing further Iron who fullfils the inclusion criteria may be switched from an existing parenteral iron treatment.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002062 |
E.1.2 | Term | Anaemia iron deficiency |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010684 |
E.1.2 | Term | Congestive heart failure |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the present study is to obtain safety reassurance with the use of Iron oligosaccharide given either as repeated IV boluses or as total dose infusion (TDI) for the correction of anaemia in patients with CHF in order to ensure that Iron oligosaccharide will not lead to unexpected adverse events in CHF patients.
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E.2.2 | Secondary objectives of the trial |
To obtain PK data (urine and serum iron - free and bound) in patients with iron deficiency (either absolute or functional) anaemia treated with Iron oligosaccharide.
To compare Hb, Hct, TSAT, serum Iron and Ferritin levels 1, 2, 4 and 8 weeks after treatment start to baseline levels.
To compare QoL at baseline and 4 and 8 weeks after baseline.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
CHF ≥ 18 years of age at screening Hb < 115 g/L (or 7.1 mmol/L) in women and Hb < 120 g/L (or 7.4 mmol/L) in men Serum Ferritin <800 µgram/L. Life expectancy beyond 12 months. Willingness to participate after written informed consent.
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E.4 | Principal exclusion criteria |
Non iron deficiency anaemia. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis). Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes). Patients with a history of multiple allergies. Decompensated liver cirrhosis and hepatitis (ALAT > 3 times normal). Acute or chronic infections (Clinical evaluation, possibly supported by CRP and WBC). Rheumatoid arthritis with symptoms or signs of active inflammation. Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception. Active bleeding. Planned elective surgery during the study where significant blood loss is expected. Participation in any other clinical trial where the study drug has not passed five half-lives prior to screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
The safety endpoints for this study are: • Adverse events (AE) • Serious adverse events (SAEs) • Physical examination • Vital signs (including ECG) • Clinical Laboratory Tests (Clinical Chemistry, Haematology (additional to efficacy parameters e.g. White blood cells, platelets etc))
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |