Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43887   clinical trials with a EudraCT protocol, of which   7297   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-001581-20
    Sponsor's Protocol Code Number:IRRB/72/14
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-001581-20
    A.3Full title of the trial
    THE ADDITION OF SIMVASTATIN ADMINISTRATION TO COLD STORAGE SOLUTION OF EXPLANTED WHOLE LIVER GRAFTS FOR FACING ISCHEMIA/REPERFUSION INJURY IN AN AREA WITH LOW RATE OF DECEASED DONATION.
    A MONOCENTRIC RANDOMIZED CONTROLLED DOUBLE-BLINDED PHASE 2 STUDY
    La somministrazione di simvastatina al donatore in aggiunta al liquido di conservazione fredda per la prevenzione del danno da ischemia/riperfusione dopo trapianto di fegato intero in un¿area con basso tasso di donazioni da cadavere.
    Uno studio di fase II, monocentrico, randomizzato, controllato, in doppio cieco.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PREVENTION OF ISCHEMIA/REPERFUSION INJURIES IN LIVER TRANSPLANTATION RECIPIENTS BY ORAL ADMINISTRATION OF SIMVASTATIN INTO THE DECEASED BRAIN DONORS DURING THE HARVESTING PROCEDURES.
    PREVENZIONE DEL DANNO DA ISCHEMIA/RIPERFUSIONE AL PAZIENTE SOTTOPOSTO AL TRAPIANTO DI FEGATO MEDIANTE SOMMINISTRAZIONE DI SIMVASTATINA AL DONATORE CADAVERE NEL CORSO DELLE FASI DI PRELIEVO CHIRURGICO.
    A.3.2Name or abbreviated title of the trial where available
    SIMVALT
    SIMVALT
    A.4.1Sponsor's protocol code numberIRRB/72/14
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN27083228
    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 SponsorISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE - ISMETT
    B.1.3.4CountryItaly
    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 supportMINISTERO DELLA SALUTE, RICERCA FINALIZZATA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS/ISMETT
    B.5.2Functional name of contact pointFRANCESCA VENUTI
    B.5.3 Address:
    B.5.3.1Street AddressVIA TRICOMI 5
    B.5.3.2Town/ cityPALERMO
    B.5.3.3Post code90127
    B.5.3.4CountryItaly
    B.5.4Telephone number00390912192111
    B.5.5Fax number00390912192400
    B.5.6E-mailfvenuti@ismett.edu
    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 SIMVASTATINA SANDOZ - 40 MG COMPRESSE RIVESTITE CON FILM 28 COMPRESSE IN BLISTER PVC/AL
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSIMVASTATINA 40 mg capsule
    D.3.2Product code SIMVA
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSIMVASTATINA
    D.3.9.1CAS number 79902-63-9
    D.3.9.2Current sponsor code190929
    D.3.9.3Other descriptive nameSIMVASTATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboNasogastric use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ISCHEMIC REPERFUSION INJURY AFTER LIVER TRANSPLANTATION: HEPATIC ISCHEMIA AND REPERFUSION INJURY REPRESENTS THE
    MAIN UNDERLYING MECHANISM FOR GRAFT DYSFUNCTION, AND FAILURE, POST-TRANSPLANTATION. HYPOXIA AND REPERFUSION
    ACTIVATE INNATE MECHANISMS OF INFLAMMATION THAT CAUSES INJURY AND UNDERLINE DELAYED GRAFT FUNCTION. IT CAUSES
    ALMOST 10% OF EARLY ORGAN FAILURE, AND CAN LEAD TO THE HIGHER INCIDENCE OF BOTH ACUTE AND CHRONIC REJECTION.
    DANNO DA ISCHEMIA RIPERFUSIONE DOPO TRAPIANTO DI FEGATO: LA SUA ESPRESSIONE CLINICA PU¿ ESSERE RAPPRESENTATA
    DAL MANCATO FUNZIONAMENTO DELL¿ORGANO TRAPIANTATO, CHE PU¿ VERIFICARSI CON PICCHI DEL 10% DEI CASI. UNA
    SINGOLA SOMMINISTRAZIONE DI SIMVASTATINA AL DONATORE CADAVERICO POTREBBE ESSERE PI¿ EFFICACE NEL MIGLIORARE IL
    METABOLISMO DELL¿ORGANO TRAPIANTATO RISPETTO ALLA SOLA RIDUZIONE FISICA DI TEMPERATURA OTTENUTA CON LA
    CONSERVAZIONE A FREDDO
    E.1.1.1Medical condition in easily understood language
    HEPATIC ISCHEMIA & REPERFUSION INJURY AFFECTS HEPATIC CELLS THAT BECOME PROINFLAMMATORY INDUCING LIVER NECROSIS, INTRAHEPATIC CELLULAR INTERACTIONS & REPERFUSION INJURY CONTRIBUTE TO LIVER DYSFUNCTION
    I PRIMI 6 MESI DOPO IL TRAPIANTO DI FEGATO ¿
    CONSIDERATO IL PERIODO PI¿ VULNERABILE A CAUSA DI POTENZIALI ESITI DEL DANNO DA ISCHEMIA/RIPERFUSIONE (ES: LA
    MANCATA RIPRESA FUNZIONALE DOPO L¿INTERVENTO)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063837
    E.1.2Term Reperfusion injury
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10024714
    E.1.2Term Liver transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10058060
    E.1.2Term Graft complication
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    TO EVALUATE THE EFFICACY OF SIMVASTATIN
    INTRAGASTRIC ADMINISTRATION USING A NASO-GASTRIC CANNULA IN ADDITION TO COLD-STORAGE FOR PREVENTING
    ISCHEMIA/REPERFUSION INJURIES. WE WILL COMPARE 3-MONTH, 6-MONTH AND 12-MONTH GRAFT SURVIVAL AFTER LIVER
    TRANSPLANTION, IN ORDER TO IDENTIFY A SIGNIFICANT RELATION INTO TWO HOMOGENOUS GROUPS OF LIVER TRANSPLANTED
    PATIENTS, ONLY DIFFERENT FOR SIMVASTATIN OR NOT ADMINISTRATION REGIMEN; USING THE SAME PROCEDURE, WITH
    IDENTICAL SURGICAL INSTRUMENTS, AND MEDICAL AND NURSING SKILLED STAFF.
    ANALIZZARE L'EFFICACIA DELLA SOMMINISTRAZIONE PER VIA INTRAGASTRICA DI SIMVASTATINA NEL
    DONATORE PRIMA DI EFFETTUARE UN TRAPIANTO DI FEGATO INTERO PER LA PREVENZIONE DEL DANNO DA
    ISCHEMIA/RIPERFUSIONE E DI CORRELARE TALE CONDIZIONE CON L¿ANDAMENTO CLINICO NEL POST-TRAPIANTO (SOPRAVVIVENZA
    CUMULATIVA DELL¿ORGANO TRAPIANTATO).
    E.2.2Secondary objectives of the trial
    TO EVALUATE THE EFFICACY OF
    SIMVASTATIN ADDITION TO COLD-STORAGE IN PREVENTING ISCHEMIA/REPERFUSION INJURIES. WE WILL COMPARE 3-MONTH, 6-
    MONTH AND 12-MONTH PATIENT SURVIVAL, HOSPITALIZATION STAYS AND ALL TRANSPLANT-RELATED COMPLICATIONS IN TERMS
    OF THE MULTI-TIER CLAVIEN GRADING SYSTEM AFTER LIVER TRANSPLANTION, IN ORDER TO IDENTIFY A SIGNIFICANT RELATION
    INTO TWO HOMOGENOUS GROUPS OF LIVER TRANSPLANTED PATIENTS, ONLY DIFFERENT FOR SIMVASTATIN OR NOT
    ADMINISTRATION REGIMEN; USING THE SAME PROCEDURE, WITH IDENTICAL SURGICAL INSTRUMENTS, AND MEDICAL AND
    NURSING SKILLED STAFF.
    METTERE A CONFRONTO LA SOPRAVVIVENZA DOPO TRAPIANTO DI FEGATO A 3 MESI, 6 MESI E 12
    MESI CON GLI ORGANI DA DONATORI STANDARD E NON, CON O SENZA LA SOMMINISTRAZIONE INTRAGASTRICA DI SIMVASTATINA.
    STUDIEREMO I GIORNI DI OSPEDALIZZAZIONE E DI TUTTE LE COMPLICANZE DEL TRAPIANTO SECONDO LA CLASSIFICAZIONE DI
    CLAVIEN, AL FINE DI INDIVIDUARE UNA RELAZIONE SIGNIFICATIVA NEI DUE GRUPPI OMOGENEI DI PAZIENTI TRAPIANTATI,
    DIFFERENTI SOLO PER IL REGIME DI TRATTAMENTO A BASE DI SIMVASTATINA; UTILIZZANDO LA STESSA PROCEDURA, CON
    STRUMENTI CHIRURGICI IDENTICI E PERSONALE SPECIALIZZATO MEDICO E INFERMIERISTICO.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) PATIENT (MALE AND FEMALE) OVER 18 YEARS OF AGE.
    2) DECEASED BRAIN DONOR (MALE AND FEMALE) OVER 18 YEARS OF AGE.
    3) THE FEMALE PATIENTS IN POTENTIALLY ABLE TO TAKE A PREGNANCY UNDERTAKE TO ENSURE EFFECTIVE PRACTICE OF BIRTH
    CONTROL DURING THE FIRST 6 MONTHS OF STUDY AFTER THE WHOLE LIVER TRANSPLANT.
    4) PATIENT WITH LIVER DISEASE AT THE STADIUM OR TERMINAL CANCER LIVER DISEASE, AND SUITABLE CANDIDATE PLACED IN
    WAITING LIST FOR LIVER WHOLE PRIMARY AT ISMETT.
    5) PATIENT UNDERWENT LIVER TRANSPLANTATION FROM DECEASED BRAIN DONORS (NOT IDENTICAL HLA) COMPATIBLE IN TERMS
    OF BLOOD GROUP ABO.
    6) PATIENT CAN UNDERSTAND THE PURPOSE AND RISKS OF THE STUDY, WHICH HAS BEEN FULLY INFORMED AND GIVING WRITTEN
    INFORMED CONSENT.
    7) PATIENT UNABLE TO WRITE AND / OR READ, BUT THAT IS FULLY CAPABLE OF UNDERSTANDING ORAL PROPOSAL BY THE
    RESEARCHER (OR THE APPOINTED REPRESENTATIVE) AND GIVING INFORMED CONSENT FOR ORAL TESTIFIED IN WRITING BY AN
    INDEPENDENT THIRD PERSON.
    1) PAZIENTE DI SESSO MASCHILE O FEMMINILE OLTRE I 18 ANNI DI ETÀ.
    2) DONATORE CADAVERE DI SESSO MASCHILE O FEMMINILE SUPERIORE AI 18 ANNI DI ETÀ.
    3) LE PAZIENTI DI SESSO FEMMINILE POTENZIALMENTE IN GRADO DI INTRAPRENDERE UNA GRAVIDANZA CHE SI SIANO IMPEGNATE
    A GARANTIRE UNA PRATICA EFFICACE DI CONTROLLO DELLE NASCITE DURANTE I PRIMI 6 MESI DI STUDIO DOPO IL TRAPIANTO DI
    FEGATO INTERO.
    4) PAZIENTE AFFETTO DA UNA MALATTIA EPATICA ALLO STADIO TERMINALE O PATOLOGIA ONCOLOGICA EPATICA, CANDIDATO
    IDONEO ED INSERITO IN LISTA D’ATTESA PER IL TRAPIANTO DI FEGATO INTERO PRIMARIO PRESSO ISMETT.
    5) PAZIENTE SOTTOPOSTO A TRAPIANTO DI FEGATO, DA UN DONATORE CADAVERE (NON HLA IDENTICO) COMPATIBILE IN TERMINI
    DI GRUPPO SANGUIGNO ABO.
    6) PAZIENTE IN GRADO DI COMPRENDERE LO SCOPO E RISCHI DELLO STUDIO, CHE SIA STATO PIENAMENTE INFORMATO E CHE
    ABBIA DATO CONSENSO INFORMATO SCRITTO.
    7) PAZIENTE INCAPACE DI SCRIVERE E / O LEGGERE, MA CHE SIA PIENAMENTE CAPACE DI COMPRENDERE L'INFORMAZIONE ORALE
    PROPOSTA DAL RICERCATORE (O DAL RAPPRESENTANTE NOMINATO) E CHE ABBIA DATO IL CONSENSO INFORMATO PER VIA
    ORALE TESTIMONIATA IN FORMA SCRITTA DA UNA PERSONA TERZA INDIPENDENTE.
    E.4Principal exclusion criteria
    THE FOLLOWING SUBJECTS WILL BE EXCLUDED BY DONOR POPULATION:
    (1) PREGNANT OR BREAST-FEEDING DONORS,
    (2) ALLERGIC DONOR OR WITH AUTOIMMUNE DISEASE.
    (3) DONOR REQUIRES ONGOING DOSING WITH A SYSTEMIC IMMUNOSUPPRESSIVE DRUG AT HARVESTING PROCEDURES.
    (4) DONOR KNOWN TO BE HIV POSITIVE.
    (5) DONOR WITH MALIGNANCY OR HISTORY OF MALIGNANCY, EXCEPT NON-METASTATIC BASAL OR SQUAMOUS CELL CARCINOMA
    OF THE SKIN THAT HAS BEEN TREATED SUCCESSFULLY.
    (6) DONOR HAS PREVIOUSLY RECEIVED OR IS RECEIVING AN ORGAN TRANSPLANT.
    THE FOLLOWING SUBJECTS WILL BE EXCLUDED BY RECIPIENT POPULATION:
    (1) RECIPIENTS WITH ACUTE LIVER DISEASE,
    (2) PEDIATRIC PATIENTS OR PEDIATRIC DONORS,
    (3) PATIENTS UNDERGOING RE-LT,
    (4) PATIENTS UNDERGOING SPLIT OR LIVING DONOR LIVER TRANSPLANTATION,
    (5) PATIENTS UNDERGOING COMBINED LIVER- OR OTHER SOLID (ABDOMINAL OR THORACIC) ORGAN(S) TRANSPLANTATION,
    (6) PATIENT WHO IS PARTICIPANTING OR HAVE BEEN PARTICIPATED TO ANOTHER CLINICAL TRIAL/STUDY AND/OR WHICH HAVE
    ASSUMED AN EXPERIMENTAL DRUG IN THE LAST 30 DAYS.
    (7) ANY CLINICALLY RELEVANT CONDITIONS THAT MIGHT AFFECT STUDY PARTICIPATION AND/OR STUDY RESULTS,
    (8) PATIENT WITH HISTORY OF ALLERGY OR INTOLLERANCE TO STATINS.
    (9) PATIENTS WITH HISTORY OF SUBSTANCE ABUSE, AND / OR PSYCHIATRIC DISORDERS OR CONDITIONS THAT MAY INVALID THE
    COMMUNICATION WITH INABILITY TO UNDERSTAND THE POTENTIAL RISKS AND BENEFITS OF THE STUDY.
    I SEGUENTI SOGGETTI SARANNO ESCLUSI DALLA POPOLAZIONE DEI DONATORI:
    (1) DONATORI IN GRAVIDANZA O IN FASE DI ALLATTAMENTO,
    (2) DONATORE ALLERGICO O CON MALATTIA AUTOIMMUNE.
    (3) DONATORE SOTTOPOSTO A TRATTAMENTO CON FARMACO IMMUNOSUPPRESSIVO.
    (4) DONATORE NOTO COME HIV POSITIVO.
    (5) DONATORE AFFETTO DA PATOLOGIA MALIGNA, AD ECCEZIONE DI CARCINOMA NON METASTATICO BASOCELLULARE O
    SQUAMOCELLULARE PRECEDENTEMENTE TRATTATO CON SUCCESSO.
    (6) DONATORE CHE SIA STATO SOTTOPOSTO A TRAPIANTO DI ORGANO.
    I SEGUENTI SOGGETTI SARANNO ESCLUSI DAL POPOLAZIONE DEI RICEVENTI:
    1) PAZIENTI CON INSUFFICIENZA EPATICA ACUTA,
    2) PAZIENTI PEDIATRICI O CANDIATI A TRAPIANTO DI ORGANO SOLIDO DA DONATORE PEDIATRICO,
    3) PAZIENTE CHE ABBIA GIÀ BENEFICIATO DI UN TRAPIANTO DI FEGATO.
    4) PAZIENTE CANDIDATO A TRAPIANTO DI FEGATO DA DONATORE VIVENTE O CON ORGANO EPATICO PARZIALE (TECNICA DI
    PRELIEVO SPLIT).
    5) PAZIENTE CANDIDATO A TRAPIANTO DI FEGATO COMBINATO CON ALTRI ORGANI SOLIDI ADDOMINALI O TORACICI.
    6) PAZIENTE PARTECIPANTE O CHE ABBIA PARTECIPATO A UN'ALTRO STUDIO CLINICO E / O CHE STIA ASSUMENDO O CHE ABBIA
    ASSUNTO UN FARMACO SPERIMENTALE NEGLI ULTIMI 30 GIORNI.
    7) PAZIENTE CON ASSOLUTA IMPROBABILITÀ A RISPETTARE LE VISITE PROGRAMMATICHE PREVISTE DAL PROTOCOLLO.
    8) PAZIENTI ALLERGICI O INTOLLERANTI ALLE STATINE.
    9) PAZIENTE CON QUALSIASI FORMA DI ABUSO DI SOSTANZE, E / O PORTATORE DI DISTURBI PSICHIATRICI O DI UNA CONDIZIONE
    CHE, A GIUDIZIO DELLO SPERIMENTATORE, POSSA INVALIDARE LA COMUNICAZIONE CON IL RICERCATORE STESSO.
    10) PAZIENTE DI ETÀ SUPERIORE AI 65 ANNI.
    E.5 End points
    E.5.1Primary end point(s)
    POST-TRANSPLANT LIVER ALLOGRAFT SURVIVAL
    INCIDENZA DI PERDITA DELL’ORGANO TRAPIANTATO
    E.5.1.1Timepoint(s) of evaluation of this end point
    3-MONTH, 6-MONTH, 1-YEAR POST-TRANSPLANT LIVER ALLOGRAFT SURVIVAL
    MESE 3°, 6° E 12° DOPO TRAPIANTO DI FEGATO
    E.5.2Secondary end point(s)
    POST-LIVER TRANSPLANT PATIENT SURVIVAL; INCIDENCE OF ADVERSE EVENT DURING
    THE POST-LIVER TRANSPLANT COURSE; DIFFERENCES IN TRANSAMINASES (ALT,
    AST, GGT, ALP), INTERNATIONAL NORMALIZED RATIO (INR), AND BILIRUBIN (TOTAL AND DIRECT) DURING THE POST-TRANSPLANT
    COURSE; LENGTHS OF HOSPITAL AND INTENSIVE
    CARE UNIT STAYS; CLAVIEN CLASSIFICATION WILL BE USED
    TO EVALUATE POSTOPERATIVE EVENTS AFTER TRANSPLANTATION (SURGICAL AND MEDICAL COMPLICATIONS, INCLUDING
    INFECTIONS).
    INCIDENZA DI MORTE DEL PAZIENTE DOPO TRAPIANTO DI FEGATO; INCIDENZA DI EVENTI AVVERSI DOPO TRAPIANTO DI FEGATO; DIFFERENZE TRA I PAZIENTI INCLUSI NEI DUE DIVERSI BRACCI IN TERMINE DI ASPARTATOAMINOTRANSFERASI
    (AST), ALANINA-AMINOTRANSFERASI (ALT) GAMMA-GLUTAMIL-TRANSPEPTIDASI (GGT, FOSFATASI ALCALINA
    (ALP), INR E VALORI DELLA BILIRUBINEMIA TOTALE E FRAZIONATA NEL DECORSO POST-TRAPIANTO DI FEGATO; DIFFERENZE TRA I PAZIENTI INCLUSI NEI DUE DIVERSI BRACCI IN TERMINE DI GIORNI DI
    DEGENZA OSPEDALIERA COMPLESSIVA ED IN UNIT¿ DI TERAPIA INTENSIVA; DIFFERENZE TRA I PAZIENTI INCLUSI NEI DUE DIVERSI BRACCI IN TERMINE DI COMPLICAZIONI
    POST-TRAPIANTO SECONDO LA CLASSIFICAZIONE DI CLAVIEN CHE VERR¿ UTILIZZATO PER VALUTARE GLI EVENTI POSTOPERATORI
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-MONTH, 6-MONTH, 1-YEAR POST-TRANSPLANT COURSE; 3-MONTH, 6-MONTH, 1-YEAR POST-TRANSPLANT COURSE; POST-OPERATIVE DAYS 1, 2, 7, 15, 30, 90, 120, 360, 540.; LENGTHS OF HOSPITAL AND INTENSIVE CARE UNIT STAYS; POSTOPERATIVE EVENTS IN THE FIRST 3 AND 6 MONTHS AFTER TRANSPLANTATION (SURGICAL AND MEDICAL COMPLICATIONS, INCLUDING INFECTIONS)
    3¿, 6¿ E 12¿ MESE DOPO TRAPIANTO DI FEGATO; 3¿, 6¿ E 12¿ MESE DOPO TRAPIANTO DI FEGATO; GIORNATA 2¿, 7¿, 15¿ 30¿, 90¿, 180¿, 270¿, 360¿, 540¿ POST-TRAPIANTO DI FEGATO; DATA DI DIMISSIONE DALLA DEGENZA OSPEDALIERA COMPLESSIVA ED DALLA UNIT¿ DI
    TERAPIA INTENSIVA DOPO TRAPIANTO DI FEGATO; COMPLICAZIONI POSTOPERATORIE (CHIRURGICHE E MEDICHE, COMPRESE
    LE INFEZIONI), AL 3¿ E 6¿ MESE DOPO TRAPIANTO DI FEGATO
    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 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 Yes
    E.6.13.1Other scope of the trial description
    The drug or placebo will be administered to the deceased donor (brain dead) before proceeding with surgical maneuvers in order to guarantee a correct sampling the entire organ according to routine clinical practice at the Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT), as enclosed "PROTOCOL FOR THE LIVER COLLECTION" included in the context of the Institute's Policy & Procedures (pdf file).
    It should be noted that the tolerability and safety data will be p
    La somministrazione del farmaco/Placebo sar¿ effettuata al donatore deceduto (in morte cerebrale) prima di procedere con le manovre chirurgiche atte a garantire un corretto prelievo dell¿organo intero secondo prassi clinica abituale presso l¿Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), come da allegato ¿PROTOCOLLO PER IL PRELIEVO DI FEGATO¿ incluso nel contesto delle Politica & Procedure Aziendali dell¿Istituto (file pdf).
    Si segnala che saranno forniti i d
    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) 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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 106
    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 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 2021-06-17. 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 state106
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 106
    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 SPECIFIC TREATMENTS OR CARES ARE PLANNED AFTER A SUBJECT HAS ENDED HIS/HER PARTICIPATION IN THE TRIAL (STANDARD OF CARE).
    NESSUN TRATTAMENTO SPECIFICO ¿ PREVISTO NEL DECORSO CLINICO AL DI FUORI DELLA TEMPISTICA DEL TRIAL (STANDARD OF
    CARE).
    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 Decision2018-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 23 16:02:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA