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    Summary
    EudraCT Number:2012-005782-12
    Sponsor's Protocol Code Number:P-Monofer-PP-01
    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:2013-04-17
    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 number2012-005782-12
    A.3Full title of the trial
    A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose Infusions or Standard Medical Care in Women after Postpartum Haemorrhage
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Women after Postpartum Haemorrhage
    A.3.2Name or abbreviated title of the trial where available
    P-Monofer-PP-01
    A.4.1Sponsor's protocol code numberP-Monofer-PP-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 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.3.9.1CAS number 1370654-58-2
    D.3.9.2Current sponsor codeIron oligosaccharide complex
    D.3.9.3Other descriptive nameIRON ISOMALTOSIDE 1000
    D.3.9.4EV Substance CodeSUB77675
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postpartum haemorrhage
    E.1.1.1Medical condition in easily understood language
    Postpartum haemorrhage
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10036417
    E.1.2Term Postpartum haemorrhage
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    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 this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives of the study are to evaluate the effect of iron isomaltoside 1000 compared to standard medical care on
    • Ability to increase Hb
    • Other relevant iron and RBC related biochemical parameters
    • Other fatigue symptoms
    • Symptoms of postpartum depression
    • Time of postpartum lactogenesis
    • Time of discontinuation of breastfeeding
    • Transfusion of allogenic RBCs

    The safety objective of the study is to evaluate the safety of iron isomaltoside 1000 compared to standard medical care by
    • Discontinuation due to intolerance
    • Adverse events (AEs)
    • Vitals signs
    • Biochemical safety parameters

    Other objectives
    • Validation of the postpartum questionnaire
    • Maternal milk iron level
    • Anaemia and gastrointestinal symptoms
    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 with PPH ≥ 700 and ≤ 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery
    2. 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. Women aged < 18 years
    2. Multiple births
    3. Peripartum RBC transfusion
    4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
    5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
    6. Women with a history of active asthma within the last 5 years or a history of multiple allergies
    7. Known decompensated liver cirrhosis or active hepatitis
    8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syn-drome (defined according to Dansk Selskab for Obstetrik og Gynækologi guidelines)
    9. Active acute infection assessed by clinical judgement
    10. Rheumatoid arthritis with symptoms or signs of active joint inflammation
    11. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
    12. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
    13. Not able to read, speak and understand the Danish language
    14. Any other medical condition that, in the opinion of the Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, un-stable ischaemic heart disease or uncontrolled diabetes mellitus
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to measure and compare the change in physical fatigue score from baseline to week 12 in the two treatment arms measured by the Multidimensional Fatigue Inventory (MFI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 12
    E.5.2Secondary end point(s)
    The secondary endpoints are to measure and compare the following in the two treatment arms
    • Change in Hb concentration from baseline to week 1, 3, 8 and 12
    • Proportion of women who achieve or maintain Hb levels of > 10 g/dL (6.2 mmol/L) at any time
    • Proportion of women who achieve increase from baseline in Hb concentration ≥ 2.0 g/dL (1.2 mmol/L) at any time
    • Proportion of women with decrease from baseline in Hb concentration ≥ 2.0 g/dL (1.2 mmol/L) at any time
    • Change in concentrations of p-ferritin, p-iron, p-transferrin, transferrin saturation (TSAT), reticulocyte count, and mean reticulocyte haemoglobin content (CHr) from baseline to day 3, week 1, 3, 8 and 12
    • Change in MFI physical fatigue symptoms from baseline to day 3, week 1, 3, 8 and 12
    • Change in other MFI fatigue symptoms from baseline to day 3, week 1, 3, 8 and 12
    • Change in postpartum depression symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS) from week 1 to week 3, 8 and 12
    • The amount of days from delivery to the day of postpartum lactogenesis
    • The amount of days from delivery to the day of discontinuation of breastfeeding
    • Proportion of women who has received 1 or more allogenic RBC transfusions and the number of units of RBC transfused per transfused patient during the study

    Safety endpoints
    • Proportion of women who discontinue from the study because of lack of response or intolerance of investigational drugs
    • Type and incidence of adverse drug reactions (ADRs) including any suspected unex-pected serious adverse events (SUSAR)
    • Number of AEs of special interest (i.e. hypersensitivity reactions or hypotension at pre-specified time points in relation to administration of study drug)
    • Change in haematology parameters, p-sodium, p-potassium, p-calcium, p-phosphate, p-urea, p-creatinine, p-albumin, p-bilirubin, Aspartate Aminotransferase (ASAT), and Alanine Aminotransferase (ALAT) from baseline to day 3, week 1, 3, 8 and 12

    Other endpoints
    • Validation of the postpartum questionnaire at baseline, day 3, week 1, 3, 8 and 12
    • Maternal milk iron level at day 3 and week 1
    • Change in anaemia and gastrointestinal symptoms from day 3 to week 1, 3, 8 and 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to week 12
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard Care
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 200
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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 Decision2013-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-16
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