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    Summary
    EudraCT Number:2013-004979-13
    Sponsor's Protocol Code Number:2012-496
    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:2014-01-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-004979-13
    A.3Full title of the trial
    Treatment of Preoperative Anaemia in Patients with Urogenital Cancer: A Randomised Double-Blind Placebo-Controlled Study of Intravenous Iron Isomaltide 1000 Monofer© versus Saline
    Et randomiseret, prospektivt, dobbelt-blindet interventionsstudie, som sammenligner intravenøst jern med placebo til behandling af præoperativ anæmi ved cancersygdom i nyre, blære og retroperitoneum
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Placebo Study Comparing Intravenous Iron with Saline in Treatment of Low Blood Count before Surgery in Patients with Cancer of the Kidney, Bladder or Lower Abdominal Cavity
    Et placebokontrolleret lodtrækningsforsøg med intravenøst jern til behandling af lav blodprocent før operation hos patienter med kræft i nyre, blære eller bagerst i bugvæggen
    A.4.1Sponsor's protocol code number2012-496
    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, 2032
    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 supportPharmacosmos A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrine Stissing
    B.5.2Functional name of contact pointBlood Bank 2032, Rigshospitalet
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post codeDk-2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004534359780
    B.5.6E-mailtrine.stissing@regionh.dk
    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 holderPharmacosnos 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRON(III) ISOMALTOSIDE 1000
    D.3.9.1CAS number 9004-66-04
    D.3.9.3Other descriptive nameIRON(III) ISOMALTOSIDE 1000
    D.3.9.4EV Substance CodeSUB74758
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Iron deficiency anaemia and anaemia of chronic disease
    Jernmangelanæmi og anæmi ved kronisk sygdom
    E.1.1.1Medical condition in easily understood language
    Low blood count related to iron deficiency and chronic illness
    Blodmangel pga. jernmangel eller kronisk sygdom
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10022974
    E.1.2Term Iron deficiency anemia
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10020970
    E.1.2Term Hypochromic anaemia of chronic disease
    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
    To investigate the effect of intravenous iron versus placebo on preoperative anaemia in patients with urogenital cancer
    At undersøge effekten af intravenøst jern versus placebo på præoperativ anæmi hos patienter med urogenital cancer
    E.2.2Secondary objectives of the trial
    1) To treat anaemia preoperative
    2) To increase Hb concentration postoperatively
    3) To treat anaemia postoperatively
    4) To reduce RBC tranfusion rate
    5) To reduce the RBC transfusion volume
    6) To correct the iron deficit preoperative and postoperative
    7) To evaluate the effect on fatigue preoperative and postoperative
    8) To calculate the frequence of infections postoperative
    9) To calculate the lenght of stay in the hospital
    10) To compare the change in Hb levels between the two groups
    1) Behandling af anæmi præoperativt
    2) Stigning i Hb koncentration postoperativt
    3) Behandling af anæmi postoperativt
    4) Reduktion i RBC transfusionsraten
    5) Reduktion i RBC transfusionsvolumen
    6) Korrektion af patienternes jerndeficit både præ- og postoperativt
    7) Korrelere behandlingseffekten til graden af fysisk træthed i perioden mellem behandlingsstart og til dagen før operation samt postoperativt
    8) Undersøge forekomsten af postoperative infektioner
    9) Undersøge varigheden af indlæggelsen
    10) Samenligne den mediane ændring af Hb imellem de to grupper
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Anaemia: males Hb< 13g/dL (8.0 mmol/L), females Hb< 11.3 g/dL (7.0 mmol/L)
    •Age > 18 years
    •Iron deficiency anaemia and anaemia of chronic disease: P-Ferritin<100ug/L eller P-Ferritin 100-800ug/L og TSAT<20 %
    •Able to give informed consent vulantary
    •Mænd og kvinder med anæmi (kvinder Hb< 7,0 mmol/L og mænd Hb < 8,0 mmol/L)
    •Alder >18 år og habile til at forstå patientinformation og give informeret samtykke
    •Jernmangelanæmi og anæmi ved kronisk sygdom (cancer-relateret anæmi og/eller kemoterapi-indiceret anæmi) defineret som P-Ferritin <100ug/L eller P-Ferritin 100-800ug/L og TSAT<20 %
    •Frivillig deltagelse efter afgivelse af informerede samtykke
    E.4Principal exclusion criteria
    •Anaemia< Hb= 8 g/dL (5.0mmol/L) or anaemia related to other causes than iron deficiency anaemia and anaemia of chronic disease
    •Known hypersensibility to intravenous iron
    •Acute or chronic infection (assessed by clinical judgement supplied with WBC and CRP)
    •Decompensated liver cirrhosis or hepatitis (ALAT>3x normal)
    •Rheumatoid arthritis with symptoms or signs of acute inflammation (assessed by clinical judgement and CRP)
    •Haemosiderosis or haemochromatosis
    •RBC transfusion two weeks prior inclusion
    •Intravenous iron or ESA four weeks prior inclusion
    •Uraemia with creatinine>250 umol/L or haemodialysis
    •Pregnancy
    •Participating in another clinical study
    •Anæmi< Hb= 5.0 mmol/L eller anæmi af anden årsag end jernmangelanæmi og anæmi ved kronisk sygdom
    •Personer med kendt hypersensibilitet over for i.v. jern
    •Aktiv eller kronisk infektion (klinisk vurdering, leukocyttal eller CRP)
    •Dekompenseret levercirrose og hepatitis (ALAT> 3 gange det øvre normalområde)
    •Rheumatoid arthritis med tegn på aktiv infektion (anamnese, obj. undersøgelse og CRP)
    •Hæmosiderose eller hæmokromatose
    •Blodtransfusion 2 uger før inklusion
    • I.v. jern- eller erythropoietin stimulerende tilskud (ESA) 4 uger før inklusion
    •Uræmi med kreatinin >250 umol/L eller hæmodialyse
    •Graviditet (positiv graviditetstest) eller ammende kvinder. Postmenopausale kvinder (defineret som udebleven menstruation i mere end 12 måneder før studieindrulling), kirurgisk steriliserede kvinder (bilateral tubektomi, hysterektomi og bilateral ovarietomi) og kvinder med sikker antikonception (spiraler eller hormonel antikonception) fritages for graviditetstest. For fertile kvinder skal sikker antikonception bruges gennem hele forsøgsperioden og 3 måneder efter infusionen.
    •Deltagelse i andet klinisk studie med farmakologiske eller transfusionsmedicinske interventioner
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with a mean increase in Hb level > 0.97 g/dL (0.6mmol/L) or who normalize Hb concentration from the day of intervention to the day before surgery
    Andelen af patienter med en gennemsnitlig stigning i B-hæmoglogin (∆Hb) på >0,6 mmol/L eller som opnår normal Hb koncentration fra start af præoperativ behandling til dagen før operation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 14 days
    Ca. 14 dage
    E.5.2Secondary end point(s)
    1. The proportion of patients with Hb level within normal range the day before surgery (male> 13.4 g/dL (8.3 mmol/L), female> 11.8 g/dL (7.3 mmol/L))
    2. The proportion of patients with a mean increase in Hb level > 0.97 g/dL (0.6mmol/L) from the day of intervention to two weeks postoperative
    3. The proportion of patients with Hb level within normal range two weeks postoperative (male> 13.4 g/dL (8.3 mmol/L), female> 11.8 g/dL (7.3 mmol/L))
    4. Reduction of the rate of RBC transfusion (percentage of patients with RBC transfusion from the day before surgery to last visit)
    5. Reduction of RBC transfusion requirement (number of RBC transfusions per transfused patient from the day before surgery to last visit).
    6. The proportion of patients (with P-ferritin <100ug/L at sceening visit) with normal ferritin levels (P-ferritin >100 ug/L and TSAT >20 %) the day before surgery and two weeks postoperative
    7. Significant change in fatigue symptoms measured by quality of life (QLQ) and fatigue questionnaires the day before surgery and two weeks postoperative
    8. The propotion of patients with infections after surgery.
    9. Lenght of stay in the hospital in days
    10. Comparison of the change of ∆Hb between the two groups
    1. Andelen af patienter med en Hb koncentration inden for normalområdet dagen før operation (kvinder≥7,3 mmol/L, mænd≥8,3mmol/L)
    2. Andelen af patienter med en gennemsnitlig stigning i B-hæmoglogin (∆Hb) på >0,6mmol/L fra start af præoperativ behandling til 2 uger postoperativt
    3. Andelen af patienter med normal Hb koncentration ved afslutning af optimeret behandling 2 uger postoperativt (kvinder≥7,3 mmol/L, mænd≥8,3 mmol/L)
    4. Reduktion af transfusionsraten (andelen af patienter med RBC transfusion fra dagen før OP til sidste forsøgsbesøg)
    5. Reduktion af transfusionsvolumen (antal portioner RBC pr. transfunderet patient fra dagen før OP til sidste forsøgsbesøg)
    6. Andelen af patienter (med P-Ferritin<100ug/L ved anæmiscreen1) med normalisering af jerndepoterne (P-Ferritin>100ug/L, TSAT>20 %) dagen før operation og 2 uger postoperativt
    7. Signifikant klinisk ændring i subjektivt oplevet fysisk træthed målt med validerede spørgeskemaer om træthed dagen før operation og 2 uger postoperativt
    8. Andelen af patienter med infektion (pneumoni billeddiagnostisk verificeret, sårinfektion verificeret ved dyrkning eller purulent sekret og anden bakteriel infektion verificeret ved dyrkning, PCR eller billeddiagnostisk) postoperativt
    9. Indlæggelsestid i dage
    10. Den mediane ændring i Hb-niveau sammenlignes mellem grupperne
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 2-4 weeks
    Ca. 2-4 uger
    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 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 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
    Last patient last vist
    Sidste patient sidste besøg
    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 months0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state84
    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
    Ingen
    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 Decision2014-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-12-12
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