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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002478-30
    Sponsor's Protocol Code Number:FLUSH
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-06-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002478-30
    A.3Full title of the trial
    Arterial perfusion with t-PA in donation after cardiac death (DCD) to reduce the incidence of non-anastomotic biliary strictures after orthotopic liver transplantation
    Arteriële perfusie met t-PA bij donatie na hartstilstand om de incidentie van galwegstricturen en ischemie-reperfusieschade na orthotope levertransplantatie te reduceren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of narrowing of the biliary tree tract after liver transplantation by flushing the donor liver with a clot-dissolving agent
    Het voorkomen van vernauwingen van de galwegen na levertransplantatie door de donorlever te spoelen met een stolseloplossend medicijn
    A.3.2Name or abbreviated title of the trial where available
    FLUSH
    A.4.1Sponsor's protocol code numberFLUSH
    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 SponsorLeiden University Medical Center
    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 supportFondsNutsOhra
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFonds Nuts Ohra
    B.5.2Functional name of contact pointFonds Nuts Ohra
    B.5.3 Address:
    B.5.3.1Street AddressAmstelplein 6
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1000 AE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205949690
    B.5.5Fax number00312059944940
    B.5.6E-mailinfo@fondsnutsohra.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 Actilyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim BV
    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.3.1Product nameActilyse
    D.3.2Product code B01AD02
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtissue-plasminogen activator
    D.3.9.1CAS number SID 50068525
    D.3.9.2Current sponsor codeB01AD02
    D.3.9.3Other descriptive nameTISSUE PLASMINOGEN ACTIVATOR
    D.3.9.4EV Substance CodeSUB32223
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 solution for infusion
    D.8.4Route of administration of the placeboIntraarterial use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Biliary strictures after orthotopic liver transplantation caused by microthrombi in the donorliver during procurement
    Het voorkomen van galwegstricturen na transplantatie die veroorzaakt worden door microhthrombi in de donorlever.
    E.1.1.1Medical condition in easily understood language
    Narrowing of the biliary tree after liver transplantation
    Het voorkomen van vernauwingen van de galwegen door donorlever te spoelen met een stolseloplossend medicijn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Prevention of biliary strictures after liver transplantation
    Voorkoming van galwegstricturen na levertransplantatie
    E.2.2Secondary objectives of the trial
    • Graft survival
    • Patient survival
    • Number of graft failures due to biliary strictures
    • Transplantaat overleving
    • Patient overleving
    • Het aantal leverfalen door galwegstricturen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Recipient inclusion criteria

    - All patients who are eligible for liver transplantation


    Donor inclusion criteria

    - Donors from donation after cardiac death (DCD)
    Ontvanger inclusie criteria

    - Alle patiënten die in aanmerking komen voor levertransplantatie


    Donor inclusie criteria

    - Donor lever afkomstig van donoren na hartstilstand
    E.4Principal exclusion criteria
    Patients eligible for liver transplantation younger than <18
    Pregnant women
    Patienten die aanmerking komen voor levertransplantatie jonger dan 18 jaar
    Zwangere vrouwen
    E.5 End points
    E.5.1Primary end point(s)
    The incidence (number) of biliary strictures after liver transplantation
    Het aantal galwegstricturen na levertransplantatie
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) On indication due to clinical symptoms
    2) Evaluation using MRI of the biliary tree 1 year after liver transplantation
    1) Op indicatie bij klinische symptomen
    2) Evaluatie van de galboom 1 jaar na levertransplantatie
    E.5.2Secondary end point(s)
    1) Graft survival
    2) Patient survival
    3) Number of graft failures due to biliary strictures
    4) Number of ERCPs, PTCs and surgical interventions performed to treat NAS in the first year
    5) Number of hospitalizations and time of hospitalization
    6) Number of admission days to the Intensive Care Unit (ICU)
    7) Number of episodes of cholangitis
    8) Adverse events (AE) and serious adverse events (SAE)
    9) Ischemia times and relation to NAS
    10)Transaminase peaks (ALAT/ASAT, bilirubin)
    11)Peri-operative blood loss
    12)Clotting, fibinolysis and remnants of t-PA in the recipients plasma
    13)Primary non-function
    14)Hepatic artery thrombosis (HAT)
    15)Retransplantations due to biliary strictures
    16)1-week liver biopsy for evaluation of ischemia/reperfusion damage
    1) Transplantaat overleving
    2) Patient overleving
    3) Aantal leverfalen door galwegstricturen
    4) Aantal ERCPs, PTCs en chirurgische interventies om galwegstricturen te behandelen binnen 1 jaar
    5) Aantal ziekenhuisopnames en aantal dagen van opname
    6) Aantal opnamedagen op de Intensive Care Unit (ICU)
    7) Aantal cholangitiden
    8) Adverse events (AE) en serious adverse events (SAE)
    9) Ischemie tijden
    10) Transaminase pieken(ALAT/ASAT, bilirubin)
    11) Peri-operatief bloedverlies
    12) Restanten van t-PA activiteit in het plasma van de ontvanger
    13) Primaire non-functie (PNF)
    14) Arteria Hepatica Trombose (HAT)
    15) Retransplantaties door galwegstricturen
    16) Leverbiopt na 1 week ter evaluatie van de ischemie-reperfusieschade
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) On indication (retransplantation)
    2) On indication
    3) On indication (clinical symptoms) within 1 year
    4) On indication (clinical symptoms) within 1 year
    5) On indication (clinical symptoms) within 1 year
    6) On indication (clinical symptoms) within 1 year
    7) On indication (clinical symptoms) within 1 year
    8) On indication (clinical symptoms) within 1 year
    9) pre-operatively
    10) 1week post transplantation
    11) per-operatively
    12) per-operatively
    13) On indication (clinical symptoms) within 1 year
    14) On indication (clinical symptoms) within 1 year
    15) On indication (clinical symptoms) within 1 year
    16) 1 week post-transplantation
    1) Op indicatie (retransplantatie)
    2) Op indicatie
    3) Op indicatie (klinische symptomen) binnen 1 jaar
    4) Op indicatie (klinische symptomen) binnen 1 jaar
    5) Op indicatie (klinische symptomen) binnen 1 jaar
    6) Op indicatie (klinische symptomen) binnen 1 jaar
    7) Op indicatie (klinische symptomen) binnen 1 jaar
    8) Op indicatie (klinische symptomen) binnen 1 jaar
    9) pre-operatief
    10) 1week post transplantatie
    11) per-operatief
    12) per-operatief
    13) Op indicatie (klinische symptomen) binnen 1 jaar
    14) Op indicatie (klinische symptomen) binnen 1 jaar
    15) Op indicatie (klinische symptomen) binnen 1 jaar
    16) 1 week post-transplantatie
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 concerned3
    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 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
    The end of the trial will be at when the total number of patients are included and the last patient has 1 year of follow-upm. An interim-analysis will be performed upon 70% inclusion fraction to study efficacy.
    De studie zal eindigen als de laatste patient 1 jaar follow-up heeft gehad. Er zal tevens een interim-analyse plaatsvinden (70% inclusiefractie) voor superioriteits of futiliteits analyse.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 2013-06-04. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In case of acute liver failure patients will be given donor livers of any origin upon availability. Waiting for informed consent will cause an unacceptable delay.
    In het geval van acuut leverfalen zal de patient de eerste beschikbare lever onvangen. Toestemming vragen zou een onacceptabele vertraging veroorzaken.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state194
    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)
    Normal treatment shall be given to all patients particpating in this trial
    Alle transplantatiepatienten die meedoen aan deze studie zullen standaard behandelingen krijgen na het einde van de studie.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Trial buro of the department of gastroenterology and hepatology
    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 Decision2013-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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