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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-023790-19
    Sponsor's Protocol Code Number:Monofer-ISS-Blooddonor-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-08-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-023790-19
    A.3Full title of the trial
    Et randomiseret, prospektivt, dobbeltblindt, komparativt, placebokontrolleret forsøg med intravenøs indgift af jernisomaltosid 1000 (Monofer®) via infusioner til bloddonorer med jernmangel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sammenligneligt placebokontrolleret forsøg med jernisomaltosid (Monofer) til bloddonorer med jernmangel
    A.3.2Name or abbreviated title of the trial where available
    Monofer-ISS-Blooddonor-01
    A.4.1Sponsor's protocol code numberMonofer-ISS-Blooddonor-01
    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 SponsorRigshospitalet, afd. 2034
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacosmos CRO
    B.5.2Functional name of contact pointLars Lykke Thomsen
    B.5.3 Address:
    B.5.3.1Street AddressRørvangsvej 30
    B.5.3.2Town/ cityHolbæk
    B.5.3.3Post code4300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4559485935
    B.5.5Fax number+4559485960
    B.5.6E-mailllt@pharmacosmos.com
    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 Monofer
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacosmos A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameMonofer
    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.3.11 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 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
    Forsøg med intravenøs indgift af jernisomaltosid 1000 (Monofer®) via infusioner til bloddonorer med jernmangel. Dobbelblindet, placebokontrolleret forsøg.
    E.1.1.1Medical condition in easily understood language
    I dette forsøg ønsker man at undersøge, hvordan jern, der i stedet for at blive givet som tabletter, gives direkte i blodbanen, virker på bloddonorer.
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10022974
    E.1.2Term Iron deficiency anemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • At vurdere effekten af intravenøs jernisomaltosid 1000 (Monofer®) sammenlignet med placebo til kvindelige førstegangsdonorer med P-ferritin under 30 µg/l.
    E.2.2Secondary objectives of the trial
    • At sammenligne ændringerne i Hb-koncentrationer fra baseline til lige inden anden donation
    • At sammenligne antallet af forsøgspersoner, som ikke kan tåle 3 donationer på grund af cHb < LA, mellem de to grupper
    • At sammenligne jernrelaterede parametre (Hb, serumjern, serumferritin, TfS og retikulocytter) mellem de to grupper
    • Livskvalitet (spørgeskema, herunder Fatique Visual Numeric Scale og 5 valgte spørgsmål fra Fatique Severity Scale (FSS))
    • Motionstolerance (to-punkts test på cykel)
    • At sammenligne antallet af uønskede hændelser relateret til forsøgslægemidlet (AE'er/SAE'er/SUSAR'er) mellem forsøgspersoner, som får jernisomaltosid 1000 (Monofer®)-infusion, og forsøgspersoner, som får placebo-infusion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Kvindelige førstegangsdonorer
    2. Over 18 år
    3. P-ferritin < 30 microgram/l
    4. Personen er villig til at deltage efter informeret samtykke.
    E.4Principal exclusion criteria
    1. Jernoverbelastning eller forstyrrelser i jernudnyttelsen (f.eks. hæmokromatose og hæmosiderose)
    2. Kendt overfølsomhed over for et eller flere af hjælpestofferne i forsøgslægemidlet.
    3. Forsøgspersoner med allergi i anamnesen.
    4. Forsøgspersoner med aktiv astma inden for de sidste 5 år.
    5. Dekompenseret levercirrhose og hepatitis (alaninaminotranferase (ALT) > 3 gange den øvre normalgrænse).
    6. Aktive akutte eller kroniske infektioner (vurderet ved klinisk skøn), understøttet af leukocyttal (WBC) og C-reaktivt protein (CRP).
    7. Rheumatoid arthritis med symptomer eller tegn på aktiv inflammation.
    8. Forsøgspersoner, som er gravide eller ammer (For at udelukke graviditet skal kvinder være postmenopausale (mindst 12 måneder siden sidste menstruation) eller være steriliseret eller, for reproduktionsdygtige kvinder, anvende en af følgende præventionsmetoder i hele forsøgsperioden og i mindst 5 biologiske plasmahalveringstider for forsøgslægemidlet efter forsøgets afslutning: P-piller, spiral, injektionspræparat af gestagen med depotvirkning, subdermalt implantat, vaginalring og depotplastre.)
    9. Deltagelse i et andet klinisk forsøg mindre end 5 halveringstider for det relevante forsøgslægemiddel inden screening.
    10. Ubehandlet B12-vitamin- eller folatmangel.
    11. Anden i.v. eller peroral jernbehandling inden for 4 uger før screeningsbesøget.
    12. Behandling med erytropoietin inden for 4 uger før screeningsbesøget.
    E.5 End points
    E.5.1Primary end point(s)
    Ændring i Hb-koncentrationer fra baseline (inden første donation) til lige inden tredje donation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ca. 3 mdr.
    E.5.2Secondary end point(s)
    • Ændring i Hb-koncentrationer fra baseline til lige inden anden donation
    • Antallet af forsøgspersoner, som ikke kan tåle 3 donationer på grund af cHb < LA
    • Ændring fra baseline i koncentrationer af serumferritin, serumjern, transferrinmætning (TfS), retikulocytter
    • Livskvalitet (spørgeskema, herunder Fatique Visual Numeric Scale og 5 valgte spørgsmål fra Fatique Severity Scale (FSS))
    • Motionstolerance (to-punkts test på cykel)
    • Antallet af forsøgspersoner i hver randomiseringsgruppe, som oplever enhver uventet og alvorlig formodet bivirkning (SUSAR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-6 mdr.
    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 Yes
    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) 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 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 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
    Sidste forsøgspersons sidste besøg (Last Subject Last Visit) er den seneste af følgende datoer: enten datoen for sidste besøg af den sidste forsøgsperson, der gennemfører forsøget, eller datoen for modtagelse af det sidste datapunkt for den sidste forsøgsperson, der er nødvendigt til den statistiske analyse (dvs. de resultater vedrørende sikkerhed og effekt, der er grundlaget for lægelige afgørelser).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned 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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 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
    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 Decision2011-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-03-19
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