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    Summary
    EudraCT Number:2011-005650-54
    Sponsor's Protocol Code Number:MD2011.01
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-04
    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 ConcernedFinland - Fimea
    A.2EudraCT number2011-005650-54
    A.3Full title of the trial
    Prothrombin complex concentrate in the reduction of blood loss during otrhotopic liver transplantation.
    Prothrombine complex concentraat in de reductie van bloedverlies tijdens orthotope levertransplantatie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prothrombin complex concentrate in liver transplantation
    Prothrombine complex concentraat in lever transplantatie.
    A.3.2Name or abbreviated title of the trial where available
    PROTON trial
    Proton studie
    A.4.1Sponsor's protocol code numberMD2011.01
    A.5.4Other Identifiers
    Name:Nederlandse Trial RegisterNumber:NTR3174
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportSanquin Plasma Products
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointSecretary surgery
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post codePO 30.001
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003150361 28 96
    B.5.5Fax number003150361 30 23
    B.5.6E-mailf.arshad@umcg.nl
    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 Cofact
    D.2.1.1.2Name of the Marketing Authorisation holderSanquin
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 37224-63-8
    D.3.9.3Other descriptive namePROTHROMBIN COMPLEX CONCENTRATES
    D.3.9.4EV Substance CodeSUB33011
    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
    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
    liver cirhosis
    coagulopathy
    bleeding
    lever cirrose
    coagulopathie
    bloeding
    E.1.1.1Medical condition in easily understood language
    chronic liver disease
    clotting problems
    bleeding
    chronische lever ziekte
    stollings stoornis
    bloeding
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10009802
    E.1.2Term Coagulopathy
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024716
    E.1.2Term Liver transplantation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10049227
    E.1.2Term Bleeding time abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024667
    E.1.2Term Liver cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether preoperative infusion of prothrombin complex concentrate (PCC) in patients with liver cirrhosis and a prolonged INR undergoing OLT reduces perioperative blood loss and transfusion requirements.
    E.2.2Secondary objectives of the trial
    To study the haemostatic safety of preoperative PCC administration in patients with cirrhosis undergoing liver transplantation. The haemostatic safety will be monitored by adverse event surveillance and laboratory measurements, with a special focus on thrombogenicity. Also estimated blood loss during surgery and estimated ascites according to the aneathesiologist will be recorded but will not serve as an endpoint since it cannot be accurately measured.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - >18 years
    - Eligible for orthotopic liver transplantation
    - INR>1.5
    - Signed informed consent
    - >18 jaar
    - komt in aanmerking voor orthotope lever transplantatie
    - INR>1.5
    - Signed informed consent
    E.4Principal exclusion criteria
    - Previous liver transplantation
    - Split liver transplantation
    - Heterotopic liver transplantation
    - Scheduled multiorgan transplantation,
    - Scheduled living related-donor transplantation
    - Renal insufficiency requiring dialysis
    - Documented congenital coagulation disorders
    - Documented history or presence of arterial or venous thrombosis
    - Treatment with warfarin/coumarin
    - TIPS (transjugular intrahepatic portosystemic shunt)
    - Fulminant hepatic failure
    - Documented coronary artery disease
    - Documented thrombophilia
    - Eerdere lever transplantatie
    - Split lever transplantatie
    - Heterotope lever transplantatie
    - Geplande multiorgaan transplantatie
    - Geplande 'living related-donor' transplantatie
    - Nier insufficientie met dialyse behoefte
    - Bekende voorgeschiedenis van congenitale stollingziektes
    - Bekende voorgeschiedenis of aanwezigheid van arteriele of veneuze thrombose
    - Behandeling met warfarine/coumarine
    - TIPS (transjugulaier intrahepatische portosystemische shunt)
    - Acute lever falen
    - Gedocumenteerde coronairlijden
    - Gedocumenteerde thrombofilie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the number of RBC units transfused during the OLT procedure and in the 24 hour post-surgery period.
    De primaire eindpunt is de hoeveelheid RBC transfusie tijdens de OLT procedure en binnen 24 uur na de chirurgische ingreep.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - During different stages of surgery: pre-anhepatic stage, anhepatic stage and reperfusion stage.
    - Withing 24hours after surgery.
    - Tijdens de verschillende stadia van chirurgie: pre-anhepatische fase, anhepatische fase en reperfusie fase.
    - Binnen 24 uur na chirurgie.
    E.5.2Secondary end point(s)
    • transfusion of fresh-frozen plasma
    • transfusion of platelet concentrate
    • transfusion of fibrinogen concentrate
    • transfusion of antifibrinolytic drugs
    • crystalloids or colloids administered
    • other escape medication used
    • estimated amount of blood loss and ascites loss during surgery
    • transfusie van aantal units fresh-frozen plasma
    • transfusie van plaatjes concentraat
    • transfusion van fibrinogeen concentraat
    • transfusion van antifibrinolytische medicijnen
    • crystalloide of colloide transfusie
    • andere 'escape'medicatie
    • geschatte bloedverlies en ascites verlies tijdens de chirurgische ingreep.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - During different stages of surgery: pre-anhepatic stage, anhepatic stage and reperfusion stage.
    - Withing 24hours after surgery
    - Tijdens de verschillende stadia van chirurgie: pre-anhepatische fase, anhepatische fase en reperfusie fase.
    - Binnen 24 uur na chirurgie.
    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) 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Yes
    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
    - Unacceptable safety concerns
    - Inconclusive results during the interim analysis and it is expected that no significance will be reached
    - Apparent benefit in the treatment group compared to the placebo group
    - In case new external information arrises that convincingly answers the study question or raises serious safety issues
    - Onacceptabele veiligheidsrisico's
    - Inconclusieve resultaten van de interim analyse met de verwachting dat er ook geen significantie bereikt kan worden
    - Overduidelijke voordeel in de behandelinggroep vergeleken met de placebogroep
    - Indien er nieuwe data bekend wordt dat overduidelijk de vragen in deze studie beantwoord of ernstige veiligheidsrisico's aantoont.
    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 months0
    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 months0
    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.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) No
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    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 treatment and care of the trial participants after their participation has ended is the same as the normal treatment of that condition.
    De verdere behandeling en zorg van de deelnemers aan deze studie na afloop van de studie is hetzelfde als de normale behandeling van de aandoening.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Clinical Trial Center Maastricht
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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