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    Summary
    EudraCT Number:2012-001529-28
    Sponsor's Protocol Code Number:P-Monofer-BD-02
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-15
    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 number2012-001529-28
    A.3Full title of the trial
    A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions to Iron-Deficient Blood Donors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions to Iron-Deficient Blood Donors
    A.3.2Name or abbreviated title of the trial where available
    P-Monofer-BD-02
    A.4.1Sponsor's protocol code numberP-Monofer-BD-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 SponsorPharmacosmos A/S
    B.1.3.4CountryDenmark
    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 supportPharmacosmos A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacosmos A/S
    B.5.2Functional name of contact pointClinical R & D
    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+4559485959
    B.5.5Fax number+4559485962
    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 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 INNIron Isomaltoside 1000
    D.3.9.1CAS number 9004-66-4
    D.3.9.3Other descriptive nameIron oligosaccharide complex
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Female first-time bloddonors with iron deficiency
    E.1.1.1Medical condition in easily understood language
    Female first-time bloddonors with iron deficiency
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10022974
    E.1.2Term Iron deficiency anemia
    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
    The primary efficacy objective of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo in first-time female donors with p-ferritin below 60 µg/L.

    The safety objective of the study is to evaluate the safety of IV iron isomaltoside 1000 compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are to evaluate the effect of iron isomaltoside 1000 compared with placebo on:
    • Change in Hb concentration
    • Tolerance of three blood donations
    • Other relevant iron related biochemical parameters
    • Fatigue
    • Restless Legs Syndrome (RLS) symptoms
    • Exercise tolerance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in the study if they fulfil the following criteria:
    1. Women aged ≥ 18 years
    2. First-time donor
    3. P-ferritin < 60 µg/L
    4. Willingness to participate and signed the informed consent form
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if they fulfil any of the following criteria:
    1. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis)
    2. Known hypersensitivity to any excipients in the investigational drug products
    3. History of drug related allergies
    4. History of severe asthma
    5. Decompensated liver cirrhosis and hepatitis (defined as ALAT > 3 times upper limit of normal)
    6. Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP)
    7. Rheumatoid arthritis with symptoms or signs of active inflammation
    8. Subjects who are pregnant or nursing. In order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product
    9. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
    10. Untreated vitamin B12 or folate deficiency
    11. Treated with other IV or oral iron products within 4 weeks prior to the screening
    12. Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to measure and compare the change in Hb concentration from baseline to right before the third blood donation in the two study arms.

    The safety endpoint includes:
    • Type and incidence of adverse drug reactions (ADRs)
    • Change in haematology parameters, p-sodium, p-potassium, p-calcium, p-phosphate, p-urea, p-creatinine, p-albumin, p-bilirubin, and Alanine Aminotransferase (ALAT) from baseline to 12 weeks after first and second blood donation
    • Change in vital signs (heart rate and blood pressure) from baseline to 12 weeks after first and second blood donation
    • Change in electrocardiogram (ECG) from baseline to 12 weeks after second blood donation
    • Change in weight from baseline to 12 weeks after second blood donation
    • Change in physical condition from screening to 12 weeks after second blood donation
    E.5.1.1Timepoint(s) of evaluation of this end point
    3-6 months
    E.5.2Secondary end point(s)
    The secondary endpoints are to measure and compare the following in the two study arms:
    • Change in Hb concentrations from baseline to right before second donation
    • Number of subjects who cannot tolerate three donations due to cHb < LA
    • Change in concentrations of p-iron, p-ferritin, Transferrin Saturation (TSAT), and re-ticulocyte count from baseline to 12 weeks after first and second blood donation
    • Change in fatigue symptoms from baseline to 12 weeks after first and second blood donation measured by the Fatigue Visual Numeric Scale and five questions from the Fatigue Severity Scale (FSS)
    • Change in RLS symptoms from baseline to 12 weeks after first and second blood do-nation measured by the Cambridge-Hopkins Restless Legs Syndrome questionnaire (CH-RLSq)
    • Change in exercise tolerance from baseline to 3 weeks after baseline measured by a two-step test on bike
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-6 months
    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) 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 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
    End of Trial is defined as Last visit last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    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
    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
    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 Decision2012-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-23
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