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    Summary
    EudraCT Number:2016-000068-40
    Sponsor's Protocol Code Number:FAIR-HF2
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-20
    Trial 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 ConcernedPortugal - INFARMED
    A.2EudraCT number2016-000068-40
    A.3Full title of the trial
    Intravenous iron in patients with systolic heart failure and iron deficiency to improve morbidity & mortality
    Intravenöses Eisen bei Patienten mit systolischer Dysfunktion und Eisenmangel zur Verbesserung der Morbidität and Mortalität
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the improvement on morbitity and mortality and frequence of disease by intravenous iron therapy in patients with disturbance of heart function and iron deficiency
    Untersuchung zur Verbesserung der Krankheitshäufigkeit und Sterblichkeit von Patienten mit Störung der Herzpumpfunktion und Eisenmangel durch eine intravenöse Eisentherapie
    A.4.1Sponsor's protocol code numberFAIR-HF2
    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 SponsorUniversity Medical Centre Hamburg-Eppendorf
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDeutsches Zentum für Herz-Kreislauf-Forschung
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportVifor Pharma
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Hamburg-Eppendorf
    B.5.2Functional name of contact pointMahir Karakas
    B.5.3 Address:
    B.5.3.1Street AddressMartinistrasse 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number004940741057975
    B.5.5Fax number004940741055619
    B.5.6E-mailm.karakas@uke.de
    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 Yes
    D.2.1.1.1Trade name Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for injection/infusion
    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 INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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/infusion
    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
    Systolic heart failure associated with iron deficiency
    Systolische Dysfunktion des Herzens in Verbindung mit einem Eisenmangel
    E.1.1.1Medical condition in easily understood language
    Reduced heart's pumping associated with iron deficiency
    Verminderte Pumpfunktion des Herzes in Verbindung mit einem Eisenmangel
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10074631
    E.1.2Term Systolic heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the FAIR-HF2 trial is to show that treatment of patients with systolic heart failure and iron deficiency with i.v. iron (Ferric Carboxymaltose, FCM) versus placebo (i.v. NaCl) can reduce the rate of the combined endpoint of recurrent heart failure hospitalisations and cardiovascular death during at least 12 months follow-up.
    Primärer Zielparameter der FAIR-HF2 Studie ist zu zeigen, dass die Behandlung von Patienten mit systolischer Dysfunktion des Herzens und einem Eisenmangel mit i.v. Eisengaben (Carboxymaltose) gegen Plazebo (i.v. NaCl) die Rate des Eintretens des kombinierten Endpunkts aus erneuter Hospitatlisierung und kardiovaskulärem Tod während einer mindestens 12-monatigen Nachbeobachtungszeit reduziert.
    E.2.2Secondary objectives of the trial
    Secondary objectives include the demonstration that in these patients treatment with FCM versus placebo can reduce the rate of recurrent cardiovascular hospitalisations, the rate of recurrent hospitalisations of any kind, and of all-cause mortality. An additional aim is to show the cost-effectiveness of the intervention.
    Die sekundären Zielparameter beinhalten, dass in mit i.v. Eisen behandelten Patieneten die Rate der erneuten Krankenhausaufenthalte auf Grund kardiovaskulärere Probleme, die Rate erneuter Krankenhausaufenthalte allgemein und die Mortalität in diesem Kollektiv vermindert ist. Auch soll die Kosteneffizienz der Behandlung untersucht werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with chronic HF (CHF) present for at least 12 months
    2. Confirmed presence of ID (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)
    3. Serum haemoglobin of 9.5 to 14.0 g/dL
    4. At time of screening considered re-stabilized and planned for discharge within next 24 h, or stable ambulatory with a HF hospitalisation in the past 6 months, or stable ambulatory with BNP > 100 pg/mL or NT-proBNP > 300 pg/mL or MR-proANP > 120 pmol/L
    5. LVEF ≤ 45 % (documented within the last 12 months prior to screening), NYHA class II or III
    6. Written informed consent
    1. Patienten mit einer chronischen Herzerkrankung für mindestens 12 Monate
    2. Bestätigter Eisenmangel (ferritin < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)
    3. Serumhämoglobin zwischen 9.5 und 14.0 g/dL
    4. Zum Zeitpunkt des Screenings vermuteter stabiler Zustand des stationären Patienten und geplante Entlassung innerhalb von 24h, oder stabiler ambulanter Patient mit Hospitalisierung aufgrund einer Herzerkrankung in den letzten 6 Monaten oder stabiler ambulanter Patient mit BNP > 100 pg/mL or NT-proBNP > 300 pg/mL or MR-proANP > 120 pmol/L
    5. LVEF ≤ 45 % (dokumentiert innerhalb von 12 Monaten vor dem Screening), NYHA class II or III
    6. Schriftliche Einwilligungserklärung
    E.4Principal exclusion criteria
    1. Hypersensitivity to the active substance, to FCM or any of its excipients
    2. Known serious hypersensitivity to other parenteral iron products
    3. Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia
    4. Evidence of iron overload or disturbances in the utilisation of iron
    5. History of severe asthma, eczema or other atopic allergy
    6. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
    7. Acute or chronic infection
    8. Presence of a deficiency for vitamin B12 and/or serum folate (if present, this needs to be corrected first)
    9. Use of renal replacement therapy
    10. Known allergy to FCM or its excipients
    11. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomization.
    1. Überempfindlichkeit gegen ein Bestandteil der Prüfmedikation
    2. Bekannte Überempfindlichkeit gegen ein anders parenteral zu verabreichendes Eisenpräparat
    3. Anämie, die nicht aufgrund eines Eisenmangels besteht
    4. Verdacht auf Eisenüberladung
    5. In der Krankengeschichte Schwerem Asthma, Ekzemen oder Atopischen Allergien
    6. In der Krankengeschichte Entzündliche oder Immunologische Erkrankungen
    7. Akuter oder chronischer Infekt
    8. Vitamin 12-/Folat-Mangel
    9. Renale Ersatztherapie
    10. Bekannte Allergie gegen FCM
    11. Behandlung mit einem ESA, jedweden i.v. Eisenpräparaten, und/oder einer Bluttransfusion 6 Wochen vor Randomisierung.
    E.5 End points
    E.5.1Primary end point(s)
    Combined rate of recurrent hospitalisations for heart failure and of CV death during follow-up
    Kombination aus erneuter Hospitalisierung aufgrund einer Herzerkrankung und kardiovaskulärem Tod während des Follow-ups
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least after 12 month of follow up
    Mindestens nach 12 Monaten
    E.5.2Secondary end point(s)
    • Combined rate of recurrent CV hospitalisations and of CV death during follow-up
    • Combined rate of recurrent hospitalisations for any reason and of CV death
    • Rate of recurrent CV hospitalisations
    • Rate of recurrent HF hospitalisations
    • Rate of recurrent hospitalisations of any kind
    • All-cause mortality
    • CV mortality
    • Changes in NYHA functional class, 6-minute walk-test, EQ-5D, and PGA of wellbeing during follow-up (from baseline to vari-ous time-points of follow-up)
    • Changes in renal, cardiovascular, inflammatory and metabolic parameters from baseline to end of follow-up
    • Kombination aus erneuter Hospitalisierung aufgrund einer kardiovaskulären Erkrankung und kardiovaskulärem Tod während des Follow-ups
    • Kombination aus erneuter Hospitalisierung allgemein und kardiovakulärem Tod
    • Anzahl der erneuter Hospitalisierung aufgrund einer kardiovaskulären Erkrankung
    • Anzahl der erneuter Hospitalisierung aufgrund einer Herzerkrankung
    • Anzahl der erneuter Hospitalisierung allgemein
    • Mortalität allgemein
    • Mortalität Kardiovaskulär
    • Veränderungen in der NYHA-Klassifizierung, dem 6-Minuten-Gehtest, EQ-5D, und PGA des Wohlbefindens im Follow-up
    • Veränderungen der renalen, kardiovaskulären, inflammatorischen und metabolischen Parameter zwichen Baseline und Follow-up•
    E.5.2.1Timepoint(s) of evaluation of this end point
    At least after 12 month of follow up
    Mindestens nach 12 Monaten
    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 Yes
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Serbia
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Keine
    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 Decision2016-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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