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    Summary
    EudraCT Number:2014-002107-16
    Sponsor's Protocol Code Number:Anemia2014
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-21
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-002107-16
    A.3Full title of the trial
    Double blind randomized study to evaluate the efficiency of intravenous ferric carboxymaltose in preventing anemia after cardiopulmonary bypass in children with congenital heart disease
    Doppelblind randomisierte Studie zur Evaluierung der Wirksamkeit der Gabe von Eisen(III)carboxymaltose zur Verhinderung von postoperativer Anàˆmie nach Operation angeborener Herzfehler
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Examination of effictiveness of iron containing infusion in preventing anemia after heart surgery in children
    Untersuchung der Wirksamkeit einer Eiseninfusion zur Verhinderung einer Anämie nach Herzoperation im Kindesalter
    A.3.2Name or abbreviated title of the trial where available
    Anemiastudy
    Anämiestudie
    A.4.1Sponsor's protocol code numberAnemia2014
    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 SponsorGeneral Hospital Linz
    B.1.3.4CountryAustria
    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 supportGeneral Hospital Linz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGeneral Hospital Linz
    B.5.2Functional name of contact pointAnesthesiology and Intensive Care
    B.5.3 Address:
    B.5.3.1Street AddressKrankenhausstraße 9
    B.5.3.2Town/ cityLinz
    B.5.3.3Post code4020
    B.5.3.4CountryAustria
    B.5.4Telephone number004373278062158
    B.5.5Fax number004373278062154
    B.5.6E-mailjens.meier@akh.linz.at
    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 Int
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 1-27299
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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.3.9.2Current sponsor codeVifor Int
    D.3.9.3Other descriptive nameFerinject
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia after cardiopulmonary bypass in children with congenital heart disease
    Postoperative Anämie nach Chirurgie angeborener Herzfehler
    E.1.1.1Medical condition in easily understood language
    Anemia after heart operation in children
    Blutarmut nach Herzoperationen im Kindesalter
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10002042
    E.1.2Term Anaemia deficiencies
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    More rapid increase of hemoglobin triggered by ferric carboxymaltose than with placebo
    schnellerer Hämoglobinanstieg nach Gabe von Eisen(III)carboxymaltose als nach Placebo
    E.2.2Secondary objectives of the trial
    number of red cell transfusion needed
    zahl der verbrauchten Erythrocytenkonzentrate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age 0-18 years
    open heart surgery with cardiopulmonary bypass
    informed parental consent
    0-2 months hemoglobin under 16g/dl
    3months - 6 years hemoglobin under 12 g/dl
    6 - 18 years under hemoglobin under 13,5g/dl
    Alter 0-18 Jahre
    offene Herzoperation mit Herzlungenmaschine
    unterschriebene Einwilligungserklärung der Eltern
    0-2 Monate Hämoglobin unter 16g/dl
    3 Monate - 6 Jahre unter 12 g/dl
    6-18 Jahre unter 13,5g/dl
    E.4Principal exclusion criteria
    re do operation
    postoperative extracorporal membrane oxgenation
    massive transfusion
    preceeding intravenous iron therapy
    0-2 months hemoglobin over 16g/dl
    3 months to 6 years over 12g/dl
    6 to 18 years over 13,5g/dl
    missing informed consent
    Revisionsoperation
    postoperative Versorgung mit extracorporaler Membranoxygenierung
    Zustand nach Massivtransfusion
    Zustand nach intravenöser Eisentherapie
    fehlende Einwilligungserklärung
    0-2 Monate Hämoglobin über 16g/dl
    3 Monate - 6 Jahre über 12 g/dl
    6-18 Jahre über 13,5g/dl
    E.5 End points
    E.5.1Primary end point(s)
    postoperative increase of hemoglobin
    postoperativer Hämoglobinanstieg
    E.5.1.1Timepoint(s) of evaluation of this end point
    21st postoperative day
    21. postoperativer Tag
    E.5.2Secondary end point(s)
    numbers of red cell transfusions
    Zahl der verabreichten Erythrocytenkonzentrate
    E.5.2.1Timepoint(s) of evaluation of this end point
    21st postoperative day
    21. postoperativer Tag
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    last patient last visit
    letzter patient letzte visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 100
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 100
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    according to the local standards
    entsprechend den lokalen Standarda
    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 Decision2014-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
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