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    Summary
    EudraCT Number:2006-004608-37
    Sponsor's Protocol Code Number:FER-CARS-02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2006-004608-37
    A.3Full title of the trial
    A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject®) with placebo in patients with chronic heart failure and iron deficiency.
    A.3.2Name or abbreviated title of the trial where available
    FAIR-HF (Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure)
    A.4.1Sponsor's protocol code numberFER-CARS-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVifor Pharma, Vifor (International) Ltd.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFerinject®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFerric Carboxymaltose (proposed INN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    iron deficiency in patients with chronic heart failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10022970
    E.1.2Term Iron deficiency
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine, relative to placebo, the effect of iron repletion therapy using intravenous ferric carboxymaltose (Ferinject®) on self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy in patients with chronic heart failure and iron deficiency.
    E.2.2Secondary objectives of the trial
    Main secondary objective: To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on Exercise tolerance (6-minute walk test distance).
    Other secondary objectives: To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on health related quality of life
    and to evaluate resource use and costs associated with the treatment with intravenous ferric carboxymaltose (Ferinject®) compared with placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age and signed written informed consent.
    2. In NYHA II-III functional class due to stable symptomatic CHF, and all of the following:
    a. Two weeks without cardiac hospitalisation.
    b. Patients in NYHA II must have had an acute care admission or emergency room visit for worsening of heart failure within 24 months prior to randomisation.
    c. On optimal conventional therapy (in general, optimal pharmacological treatment which includes a diuretic, a beta-blocker, and/or an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) as determined by the investigator, unless contraindicated or not tolerated).
    d. No dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics).
    e. No introduction of a new heart failure drug class during the last 4 weeks.
    3. Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHD II and 45% or lower in NYHD IIas assessed according to local methodology by 2-D echocardiography, radionuclide ventriculography, cardiac magnetic resonance imaging, or X-ray contrast ventriculography within 6 months prior to randomisation. For patients treated with beta-blockers or with cardiac resynchronisation, LVEF assessment for eligibility must be performed at least 3 months after stable beta-blocker therapy or device implantation.
    4. Screening Hb at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations as measured locally by HemoCue® analyzer; see Section 3.3.5.2).
    5. Screening ferritin below 100 μg/L, or below 300 μg/L when transferrin saturation (TSAT) is below 20% (re-screening is possible after 4 weeks for patients with borderline higher ferritin concentrations or borderline TSAT percentage if the investigator feels that levels might drop below cut-off in the near future, see Section 3.8.1.1).
    6. Resting blood pressures less than or equal to 160 mm Hg (systolic) and less than or equal to 100 mm Hg (diastolic at the disappearance of sounds, Korotkoff phase V).
    7. Adequate veins for repeated blood sampling and i.v. administration of investigational drug.
    8. Negative pregnancy test and use of adequate contraceptive methods for women of childbearing potential.
    9. Patient must be able to perform the 6 minute walk test according to investigator judgement
    E.4Principal exclusion criteria
    1. History of acquired iron overload.
    2. Known hypersensitivity to Ferinject®.
    3. Known active infection, CRP > 20 mg/L, clinically significant bleeding, active malignancy (re-screening is possible after 4 weeks for patients with elevated CRP concentrations if the investigator feels that levels might normalize in the near future, see Section 3.8.1.1).
    4. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
    5. Anaemia due to reasons other than iron deficiency (e.g. haemoglobinopathy).
    6. Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
    7. History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
    8. Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
    9. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
    10. Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
    11. Known HIV/AIDS.
    12. Inability to fully comprehend and/or perform study procedures in the investigator’s opinion.
    13. Vitamin B12 and/or serum folate deficiency according to the central laboratory (re-screening is possible after substitution therapy, see Section 3.8.1.1).
    14. Pregnancy or lactation.
    15. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
    E.5 End points
    E.5.1Primary end point(s)
    Self-reported patient global assessment (PGA) score and change in NYHA class from baseline to Week 24 visit after start of investigational drug, taking into account patients who are hospitalised at that time or have died.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other 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.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 576
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-17
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