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    Summary
    EudraCT Number:2016-000789-53
    Sponsor's Protocol Code Number:VWFC-ECMO
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-000789-53
    A.3Full title of the trial
    A pilot trial to investigate the administration of von Willebrand factor concentrate (Willfact®, LFB France) in adult patients during extracorporeal membrane oxygenation
    Eine Pilotstudie zum Einfluss von Willfact® auf den Blutverlust bei Patienten an einer transportablen Herz-Lungenmaschine

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The influence of the medication Willfact on the blood loss of patient during the use of a heart-lung machine
    Der Einfluss von Willfact® auf den Blutverlust bei Patienten an einer transportablen Herz-Lungenmaschine
    A.3.2Name or abbreviated title of the trial where available
    Willfact during ECMO
    Willfact an der ECMO
    A.4.1Sponsor's protocol code numberVWFC-ECMO
    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 SponsorMedizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
    B.1.3.4CountryAustria
    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 supportLFB Biomedicaments
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Innsbruck / Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
    B.5.2Functional name of contact pointProjektmanagement
    B.5.3 Address:
    B.5.3.1Street AddressAnichstrasse 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number004351250480451
    B.5.5Fax number004351250427793
    B.5.6E-mailmirjam.bachler@i-med.ac.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 Willfact
    D.2.1.1.2Name of the Marketing Authorisation holderLFB-BIOMEDICAMENTS
    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 nameWillfact
    D.3.4Pharmaceutical form Powder and solvent 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 INNvon Willebrand Faktor
    D.3.9.1CAS number 109319-16-6
    D.3.9.3Other descriptive nameVON WILLEBRAND FACTOR
    D.3.9.4EV Substance CodeSUB72116
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Physiologische Kochsalzlösung "Fresenius" - Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Austria GmbH
    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 namePhysiologische Kochsalzlösung "Fresenius" - Infusionslösung
    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 INNNatriumchlorid 0,9 %
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.0
    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.IMP: 3
    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 Willfact
    D.2.1.1.2Name of the Marketing Authorisation holderLFB-BIOMEDICAMENTS
    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 nameWillfact
    D.3.4Pharmaceutical form Powder and solvent 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 INNvon Willebrand Faktor
    D.3.9.1CAS number 109319-16-6
    D.3.9.3Other descriptive nameVON WILLEBRAND FACTOR
    D.3.9.4EV Substance CodeSUB72116
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 4
    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 Willfact
    D.2.1.1.2Name of the Marketing Authorisation holderLFB-BIOMEDICAMENTS
    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 nameWillfact
    D.3.4Pharmaceutical form Powder and solvent 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 INNvon Willebrand Faktor
    D.3.9.1CAS number 109319-16-6
    D.3.9.3Other descriptive nameVON WILLEBRAND FACTOR
    D.3.9.4EV Substance CodeSUB72116
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Von Willebrand Disease (VWD)
    Von Willebrand Krankheit
    E.1.1.1Medical condition in easily understood language
    Deficiency of von-Willebrand factor
    Ein Mangel an von-Willebrand-Faktor
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10069495
    E.1.2Term Acquired Von Willebrand's disease
    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
    transfusion requirement of PRBC
    Transfusionsbedarf an Erythrozytenkonzentraten
    E.2.2Secondary objectives of the trial
    - transfusion requirements of other allogenic blood products
    - requirements of coagulation factor concentrates
    - assessment of loss and restauration of vWF-HMW multimers
    - assessment of the coagulation status
    - changes in blood count, blood chemistry and blood gas
    - platelet function
    - kidney function
    - bleeding score
    - bleeding complications
    - thromboembolic complications
    - renal failure
    - cardiovascular failure
    - infections
    - morbidity
    - mortality

    - Transfusionsbedarf an anderen allogenen Blutprodukten
    - Bedarf an Faktorenkonzentraten
    - Beurteilung des Verlusts und Wiederherstellung der vWF-HMW multimere
    - Beurteilung des Gerinnungsstatus
    - Veränderungen im Blutbild, Blutchemie und Blutgas
    - Thrombozytenfunktion
    - Nierenfunktion
    - Blutungsscore
    - Blutungskomplikationen
    - thromboembolische Ereignisse
    - Nierenversagen
    - Herz-Kreislaufversagen
    - Infektionen
    - Morbidität
    - Mortalität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with the need of veno-arterial or veno-venous ECMO for a minimum of 48 hours
    - Age ≥ 18 years
    - Patient mit der Notwendigkeit einer veno-arteriellen oder veno-venösen ECMO mit einer Mindestdauer von 48 h
    - Alter ≥ 18 Jahre
    E.4Principal exclusion criteria
    - Patient with known thromboembolic event in the last 30 days
    - Inevitable lethal course
    - Severe Liver failure: Quick < 30 %
    - Pregnancy
    - Patient with known refusal of a participation in this clinical trial
    - Active participation in another clinical trial
    - Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study
    - Patient mit bekannten thromboembolischen Ereignissen innerhalb der letzten 30 Tage
    - Unausweichlicher tödlicher Verlauf
    - Schweres Leberversagen: Quick < 30 %
    - Schwangerschaft
    - Patient mit bekannter Ablehnung einer Teilnahme an dieser Studie
    - Aktive Teilnahme an einer anderen Studie
    - Umstände, wie das Vorhandensein von Laborabnormalitäten, welche den Patienten bei der Teilnahme an dieser Studie einem unakzeptablen Risiko aussetzen würden, oder die ordnungsgemäße Interpretation der gewonnenen Daten verhindern würden
    E.5 End points
    E.5.1Primary end point(s)
    - difference in the number red blood cells concentrates between the treatment arms per day
    - Unterschied in der Anzahl der täglich benötigten Erythrozytenkonzentraten zwischen den beiden Behandlungsgruppen
    E.5.1.1Timepoint(s) of evaluation of this end point
    - from the start of IMP (24h after ECMO installation) every full 24 hours
    - vom Start der Studienmedikationsgabe (24h nach der ECMO-Installation) alle 24 Stunden
    E.5.2Secondary end point(s)
    - difference in the number of other high risk allogenic transfusion products (fresh frozen plasma and platelet concentrate) between the treatment arms per day
    - amount of coagulation factor concentrates given during ECMO support between the treatment arms per day
    - measurement of vWF multimers, vWF:RCo ratio, vWF:Ag ratio, vWF:CB ratio, F:VIII, vWF-cleaving protease (ADAMTS-13) and collagen binding activity (CBA)
    - measurement of PT, aPTT, FXII, FXIII, Heparin/Argatroban-level, fibrinogen (Clauss + immune.), antithrombin, platelet count and ROTEM (InTEM, ExTEM, FibTEM)
    - difference in the blood count , chemical parameters and blood gas analysis over the ECMO period
    - difference in the platelet activation (multiplate: TRAP-test, ADP-test, Aspi-test, Risto-test)
    - daily urine output (every 24 h period)
    - difference in the bleeding scores (after Mazzeffi et al., 2013), SOFA, SAPSII und SAPS3 (first 24 h)
    - difference in the number of bleeding events
    - difference in the number of thromboembolic events
    - acute kidney injury, need for hemofiltration
    - location and type of infection
    - difference in the need of vasopressors and inotropics
    - MOD/MOF (SAPSIII, SOFA)
    - 30-day mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    daily (every 24 hours)
    or at Visit time points:
    Visit 1: before ECMO installation
    Visit 2: before IMP start
    Visit 3: 24h after IMP start
    Visit 4: 60h after IMP start
    Visit 5: 5 days after IMP start
    Visit 6: before ECMO stop (this visit can replace Visit 3, 4 or 5 if ECMO-stop is within the appropriate time window)
    Visit 7: 36h after ECMO stop
    Visit S: 36h after IMP stop if ECMO is needed longer than 7 days and is not the same as Visit 7
    Visit vWF-AB: at hospital discharge or at an ambulatory after-care appointment
    Visit 8: Interview
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) Yes
    E.8.2.2Placebo No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 the Trial = Last Patient - Last Visit (LPLV)
    Ende der klinischen Prüfung ist, wenn der letzte Patient die letzte Visite hatte
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 2016-10-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients are critical ill and therefore will not be able to give their consent due to medical reasons. As soon as the patient regains the capacity to understand and conclude, the patient will be informed and asked for his/her consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state68
    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)
    The post-treatment is not different from the expected normal treatment of that condition
    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 Decision2016-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-07-17
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