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    Summary
    EudraCT Number:2006-004608-37
    Sponsor's Protocol Code Number:FER-CARS-02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-09
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di fase III, randomizzato, in doppio cieco e controllato verso placebo volto a valutare l`efficacia e la sicurezza del carbossimaltosio ferrico (Ferinject) somministrato per via endovenosa in pazienti affetti da insufficienza cardiaca cronica e carenza di ferro
    A.3.2Name or abbreviated title of the trial where available
    FAIR-HF
    FAIR-HF
    A.4.1Sponsor's protocol code numberFER-CARS-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVIFOR (INTERNATIONAL) INC.
    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.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNIron trivalent, parenteral preparations
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Carenza di ferro in pazienti affetti da insufficienza cardiaca cronica
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10022970
    E.1.2Term Iron deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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.
    Determinare l'effetto, rispetto al placebo, della terapia di ricostituzione delle riserve del ferro utilizzando carbossimaltosio ferrico (Ferinject), basandosi sull'autovalutazione globale del paziente (PGA - patient global assessment) e sullo stato funzionale della classificazione NYHA, 24 settimane dopo l'inizio della terapia in pazienti affetti da insufficienza cardiaca cronica e sideropenia
    E.2.2Secondary objectives of the trial
    To evaluate the effect of intravenous ferric carboxymaltose (Ferinject) compared with placebo on:Exercise tolerance (6-minute walk test distance; To evaluate the effect of intravenous ferric carboxymaltose (Ferinject) compared with placebo on health related quality of life; To evaluate resource use and costs associated with the treatment with intravenous ferric carboxymaltose (Ferinject)compared with placebo
    Valutare l'effetto del carbossimaltosio ferrico (Ferinject) per via endovenosa,rispetto al placebo,su: Tolleranza all'esercizio (6 minuti di cammino; Valutare l'effetto del carbossimaltosio ferrico (Ferinject) per via endovenosa,rispetto al placebo,sulla qualita' correlata alla salute; Valutare l'uso delle risorse e dei costi associati al trattamento con carbossimaltosio ferrico (Ferinject) per via endovenosa,rispetto al placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI:
    Sottostudio con test da sforzo cardiopolmonare al teppeto rotante (VO2 di picco),per un sottogruppo di pazienti inclusi nello studio principale.
    E.3Principal inclusion criteria
    Patients who meet the following criteria at the start of treatment are eligible for the study: 1. At least 18 years of age and signed written informed consent. 2. In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF), and all of the following: a. Two weeks without cardiac hospitalisation. b. Patients in NYHA II must have had an unplanned hospital admission or emergency room visit for worsening of heart failure within one year prior to start of treatment. 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) 35% or lower as 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 start of treatment. For patients treated with beta-blockers or with cardiac resynchronisation, LVEF assessment for eligibility must be performed at least 12 weeks after stable beta-blocker therapy or device implantation. 4. Estimated glomerular filtration rate (e-GFR) below 60 mL/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease trial (MDRD) formula. 5. Screening haemoglobin (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). 6. Screening ferritin below 100 &#956;g/L, or below 300 &#956;g/L when transferrin saturation (TSAT) is below 20%. 7. 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). 8. Adequate veins for repeated blood sampling and intravenous (i.v.) administration of investigational drug. 9. Negative pregnancy test and use of adequate contraceptive methods for women of childbearing potential. 10. Patient must be able to perform the 6 minute walk test according to investigator judgement.
    I pazienti che soddisfano i seguenti criteri presentano i requisiti necessari per partecipare allo studio: 1. Almeno 18 anni di eta' e sottoscrizione di consenso informato scritto. 2. Appartenere alla classe funzionale NYHA II-III (New York Heart Association) poiche' affetti da insufficienza cardiaca cronica (CHF) stabile e sintomatica, e presentare tutte le seguenti caratteristiche: a. Non essere stati ospedalizzati nelle ultime due settimane per motivi cardiaci b. I pazienti che rientrano nella classe NYHA II devono essere stati ricoverati o visitati d'urgenza in pronto soccorso per un peggioramento dell'insufficienza cardiaca nell'anno precedente l'inizio del trattamento. c. Seguire una terapia convenzionale ottimale (in generale, un trattamento farmacologico ottimale che comprende un diuretico, un beta bloccante e/o un inibitore dell'enzima di conversione dell'angiotensina (ACE-inibitore) o un antagonista dei recettori dell'angiotensina II (ARB - angiotensin II receptor blocker), valutato dal ricercatore incaricato, a meno che non sia controindicato o non tollerato). d. La dosi dei farmaci per l'insufficienza cardiaca non devono essere state modificate nelle ultime due settimane (con l'eccezione dei diuretici) e. Non deve essere stato introdotto un farmaco per l'insufficienza cardiaca di una nuova classe nelle ultime 4 settimane. 3. Frazione di eiezione ventricolare sinistra (LVEF - left ventricular ejection fraction) inferiore o uguale al 35 p.c., valutata in base alla metodologia del centro con ecocardiografia 2-D, ventricolografia con radionuclide, risonanza magnetica cardiaca o ventricolografia di contrasto nei sei mesi precedenti lo studio. Per i pazienti trattati con beta-bloccanti o resincronizzazione cardiaca, la valutazione della LVEF ai fini dell'inclusione nello studio deve essere stata effettuata almeno 12 settimane dopo l'inizio di una terapia stabile a base di beta-bloccanti o l'impianto del dispositivo. 4. Ritmo di filtrazione glomerulare stimato (e-GFR - estimated glomerular filtration rate) inferiore a 60 mL/min/1,73 m2 calcolato utilizzando la formula dello studio ''Modification of Diet in Renal Disease Trial-MDRD''. 5. Valori di emoglobina (Hb) pari ad almeno 9,5 g/dL, ma comunque minore o uguale a 13,5 g/dL (media di 2 concentrazioni di Hb misurate con l'analizzatore HemoCue; 6. Valori di ferritina inferiori a 100 mcg/L, o inferiori a 300 mcg/L quando la saturazione della transferrina e' inferiore al 20%. 7. Valori di pressione sanguigna a riposo inferiori o uguali a 160 mmHg (sistolica) e inferiori o uguali a 100 mmHg (diastolica alla scomparsa dei toni di Korotkoff - fase V). 8. Accesso venoso adeguato per ripetuti prelievi sanguigni e somministrazione endovenosa (e.v.) del farmaco dello studio. 9. Test di gravidanza negativo e utilizzo di adeguati metodi contraccettivi per le donne in eta' fertile. 10. I pazienti devono essere in grado di effettuare il test del cammino di 6 minuti in accordo al giudizio dello sperimentatore.
    E.4Principal exclusion criteria
    Patients who, at the start of treatment, meet the following criteria are not eligible for the study: 1. History of acquired iron overload. 2. Known hypersensitivity to Ferinject. 3. Known active infection, CRP > 20 mg/L, clinically significant bleeding, active malignancy. 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.aemoglobinopathy). 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). 14. Pregnancy or lactation. 15. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
    I pazienti che, all'inizio del trattamento, soddisfano i seguenti criteri non presentano i requisiti necessari per partecipare allo studio: 1. Anamnesi di sovraccarico di ferro acquisito. 2. Ipersensibilita' nota verso Ferinject 3. Infezione nota in atto, CRP &gt; 20 mg/L, emorragie clinicamente significative, processi maligni in atto. 4. Patologia epatica cronica e/o valori di alanina transaminasi (ALT) o aspartato transaminasi (AST) tre volte maggiori dei limiti superiori del range normale. 5. Anemia dovuta a cause diverse dalla sideropenia (per esempio emoglobinopatia) 6. Terapia immunosoppressiva o dialisi renale (in atto o pianificata entro i successivi 6 mesi) 7. Anamnesi di trattamento a base di eritropoietina, o di ferro per os o e.v., e trasfusione ematica nelle 12 settimane precedenti e/o pianificazione di una terapia del genere entro i sei mesi successivi. 8. Angina pectoris giudicata instabile dal ricercatore competente, patologia valvolare non corretta clinicamente significativa od ostruzione dell'espulsione ventricolare, cardiomiopatia ostruttiva, flutter o fibrillazione atriale rapida non adeguatamente controllata, bradi- o tachiaritmie ventricolari sintomatiche non adeguatamente controllate. 9. Infarto acuto del miocardio o sindrome coronarica acuta, attacco ischemico transitorio o inferto cerebrale negli ultimi tre mesi. 10. Impianto di by-pass arterioso coronarico, intervento percutaneo (per es. cardiaco, cerebrovascolare, aortico; cateteri diagnostici sono consentiti) o intervento di alta chirurgia, compresi interventi a livello toracico e cardiaco, negli ultimi tre mesi. 11. Infezione da HIV/AIDS note. 12. Impossibilita' di partecipare pienamente alle procedure dello studio e/o di metterle in atto, secondo il ricercatore competente. 13. Deficit di Vitamina B12 o di folati sierici in base alle analisi del laboratorio centrale (e' possibile effettuare nuove analisi dopo la terapia di sostituzione). 14. Gravidanza o allattamento. 15. Partecipazione a un altro studio clinico nei precedenti 30 giorni e/o partecipazione programmata a un altro studio durante lo svolgimento di quello in questione.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: 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.
    Primari (di efficacia): Punteggio dell'autovalutazione globale del paziente (PGA) e variazione della classe NYHA dalla visita basale alla visita della settimana 24 dopo l'inizio della somministrazione del farmaco in studio, tenendo conto dei pazienti che sono ospedalizzati in quel momento o che sono deceduti.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 Decision2007-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-17
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