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    Summary
    EudraCT Number:2018-003184-65
    Sponsor's Protocol Code Number:TPL107
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-30
    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 number2018-003184-65
    A.3Full title of the trial
    POREIIL - Postoperative replacement of intraoperative iron losses
    POREIIL - Postoperativer Ersatz von intraoperativen Eisenverlusten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Postoperative replacement of iron losses happening during and after an operation
    Postoperative Ersatz von Eisenverlusten die während und nach einer Operation entstehen können
    A.3.2Name or abbreviated title of the trial where available
    POREIIL
    A.4.1Sponsor's protocol code numberTPL107
    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 SponsorVifor Pharma
    B.1.3.4CountryAustria
    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 supportVifor Pharma Austria
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVifor Pharma
    B.5.2Functional name of contact pointHead Medical AT
    B.5.3 Address:
    B.5.3.1Street AddressLinzerstrasse 221
    B.5.3.2Town/ cityAustria
    B.5.3.3Post code1140
    B.5.3.4CountryAustria
    B.5.6E-mailalexander.geisberger@viforpharma.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 Pharma
    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.3.4Pharmaceutical form Concentrate for 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 INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.3Other descriptive nameEisen(III)-Carboxymaltose
    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 placeboConcentrate and solvent for concentrate for solution 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
    perioperative bleeding induced iron losses and anemia
    perioperative Eisenverluste und damit Anämie die durch Blutverlust entstehen
    E.1.1.1Medical condition in easily understood language
    iron deficiency anemia
    Blutarmut verursacht durch Eisenmangel
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    It is therefore the aim of the proposal presented to describe an additional approach, in which perioperative, surgical blood loss iron losses are replaced immediately following the surgical procedure in patients that did not receive iron preoperatively due to normal or minor reduction in hemoglobin concentrations (red cell mass). This replacement may take place in either the postoperative anesthesia care unit or in the ICU, Although preoperative treatment of iron deficiency anemia is widely considered the most important domain of perioperative iron therapy, the additional post-operative replacement is as useful as preoperative preparation and seems to be more convenient to implement.
    Ziel des vorliegenden Vorschlags ist es daher, einen zusätzlichen Ansatz zu beschreiben, bei dem perioperative, chirurgische Blutverluste durch Eisenverluste unmittelbar nach dem chirurgischen Eingriff bei Patienten ersetzt werden, die aufgrund einer normalen oder geringen Reduzierung der Hämoglobinkonzentration (Erythrozytenmasse) kein Eisen präoperativ erhalten haben. Dieser Ersatz kann entweder auf der postoperativen Anästhesie-Station oder auf der Intensivstation erfolgen. Obwohl die präoperative Behandlung der Eisenmangelanämie weithin als wichtigster Bereich der perioperativen Eisentherapie gilt, ist der zusätzliche postoperative Ersatz genauso nützlich wie die präoperative Vorbereitung.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • patients undergoing non-emergency
    - cardiac surgery - intra-abdominal surgery • preoperative Hb (during the premedication visit):
    -male: Hb>12.5g/dl
    -female: Hb>11.5g/dl
    • postoperative Hb (immediately after surgical procedure in the recovery room):
    -2 g/dl below preoperative Hb concentration
    • age ≥ 18 years
    • Admission to intensive care unit or post-anesthesia care unit • Able to sign consent for the trial
    - kein Notfallseingriff
    - Herzchirurgie - Intraabdominalchirurgie - präoperative Hb (während des Prämedikationsbesuchs):
    männlich: Hb>12.5g/dl
    weiblich: Hb>11.5g/dl
    - postoperatives Hb (unmittelbar nach dem Eingriff im Aufwachraum): 2 g/dl unter der präoperativen Hb-Konzentration
    - Alter ≥ 18 Jahre
    - Aufnahme auf die Intensivstation oder Post-Anästhesie-Station
    - In der Lage, die Einwilligung für die Studie zu unterzeichnen.
    E.4Principal exclusion criteria
    • age < 18 years
    • emergency surgery
    • perioperative application of iron and/or erythropoietin • intraoperative transfusion of allogeneic erythrocytes
    • known hemochromatosis
    • known allergic reaction linked to iron medication
    • pregnancy
    - Alter < 18 Jahre
    - Notfallchirurgie
    - perioperative anwendung von eisen und/oder erythropoietin - intraoperative transfusion von allogenen erythrozyten
    - bekannte Hämochromatose
    - bekannte allergische Reaktion im Zusammenhang mit Eisenmedikamenten
    - bestehende Schwangerschaft
    E.5 End points
    E.5.1Primary end point(s)
    Hemoglobin concentration at 30th day following surgery
    Hämoglobin Konzentration am 30. Tag nach der Operation
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 Tage
    E.5.2Secondary end point(s)
    -number of transfusions
    -number of perioperative infections, death, myocardial infarction, acute kidney injury, stroke
    -ability to walk 10 feet at day 7 and 30 post randomization
    -6min walkin Test at day 7 and 30
    -iron profiles (serum iron, iron binding capacity)
    -Anzahl der Transfusionen
    -Anzahl der perioperativen Infektionen, Tod, Myokardinfarkt, akutes Nierenversagen, Schlaganfall
    -Fähigkeit, am Tag 7 und 30 nach der Randomisierung 10 Fuß zu gehen.
    -6min Gehzeit Test an Tag 7 und 30
    -Eisenprofile (Serum-Eisen, Eisenbindungskapazität)
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 Tage
    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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-01-30. Yes
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 360
    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 Decision2020-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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