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    Summary
    EudraCT Number:2014-005162-29
    Sponsor's Protocol Code Number:RivaSVT100
    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:2015-05-19
    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 number2014-005162-29
    A.3Full title of the trial
    Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban.
    A pilot, prospective cohort study
    Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban.
    A pilot, prospective cohort study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of portal, mesenteric, and splenic vein thrombosis with rivaroxaban.
    Terapia con rivaroxaban delle trombosi venose portali, mesenteriche e spleniche. Studio pilota, prospettico di coorte
    A.4.1Sponsor's protocol code numberRivaSVT100
    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 SponsorA.O. OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
    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 supportFondi universitari
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAO Ospedale di Circolo e Fondazione Macchi
    B.5.2Functional name of contact pointSegreteria Tecnico-Scientifica CE
    B.5.3 Address:
    B.5.3.1Street AddressBorri
    B.5.3.2Town/ cityVarese
    B.5.3.3Post code21100
    B.5.3.4CountryItaly
    B.5.4Telephone number0332393056
    B.5.5Fax number0332393631
    B.5.6E-mailraffaella.cavi@ospedale.varese.it
    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 XARELTO - 15 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE BLISTER (PP/ALU) 100 (10X10X1) COMPRESSE (DOSE UNITARIA) (CONFEZIONE MULTIPLA)
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    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 nameRIVAROXABAN
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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: 2
    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 XARELTO - 20 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    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 nameRIVAROXABAN
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Portal, mesenteric, and splenic vein thrombosis
    Trombosi venose portali, mesenteriche e spleniche
    E.1.1.1Medical condition in easily understood language
    Vein thrombosis
    Trombosi venose
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10043642
    E.1.2Term Thrombosis venous deep
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety of rivaroxaban in the treatment of patients with SVT
    Valutare la sicurezza di rivaroxaban nel trattamento delle trombosi venose portali, mesenteriche e spleniche definite come emorragie maggiori
    E.2.2Secondary objectives of the trial
    Efficacy in terms of recurrence and mortality
    Efficacia in termini di recidive e mortalità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consecutive patients aged 18 years or older with a first episode of symptomatic, objectively diagnosed PVT, MVT, or spVT will be eligible. The following diagnostic procedures will be accepted: computerized tomography, magnetic resonance imaging, and Doppler ultrasound. All eligible patients will need to provide signed informed consent.
    pazienti consecutivi di età superiore a 18 anni con un primo episodio sintomatico di trombosi venosa splancnica (vena porta, vene mesenteriche, vena splenica) diagnosticato mediante appropriate indagini radiologiche. Tutti i pazienti dovranno avere firmato il modulo di consenso informato dopo adeguata istruzione sullo studio.
    E.4Principal exclusion criteria
    Known liver cirrhosis (biopsy proven or with clinical, laboratory, or imaging evidence of chronic liver disease, within a context of chronic alcoholism, viral hepatitis, autoimmunity, Wilson’s disease, iron overload) or an alanine aminotransferase level that is three times the upper limit of the normal range or higher; Budd-Chiari syndrome; previous or ongoing variceal bleeding; presence of portal vein cavernoma at the time of diagnosis; anticipated abdominal surgical procedure; known bleeding diathesis; platelet count <100.000 mm3; creatinine clearance <30 mL/min (Cockroft-Gault formula); life expectancy of less than 3 months; expected inability to take oral medications; concomitant treatment with azole antimycotics and human immunodeficiency virus protease inhibitors; pregnancy or lactation; treatment with therapeutic doses of LMWH or UFH for more than 7 days; ongoing treatment with VKA.
    Presenza di cirrosi epatica o epatite acuta; sindrome di Budd-Chiari; sanguinamento da varici pregresso o attivo; presenza di cavernoma portale alla diagnosi; indicazione a procedura chirurgica addominale; nota diatesi emorragica; conta piastrinica <100.000 mm3; clearance della creatinina <30 mL/min; aspettativa di vita <3 mesi; impossibilità ad assumere terapia per via orale; terapia concomitante con antimicotici azolici o terapia antiretrovirale per HIV; gravidanza o allattamento; trattamento con dosi terapeutiche con eparina a basso peso molecolare o eparina non frazionata per più di 7 giorni; terapia in corso con antagonisti della vitamina K. for more than 7 days; ongoing treatment with VKA.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of major bleeding events during the 3 months of active treatment and up to 2 days after the end of study treatment
    Incidenza di emorragie maggiori (secondo i criteri ISTH) durante i 3 mesi di trattamento attivo e fino a 2 giorni dopo la sospensione del farmaco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months+2 days after the end of study treatment
    3 mesi + 2 giorni dopo la sospensione del farmaco.
    E.5.2Secondary end point(s)
    Mortality, clinically relevant non-major bleeding occurred during 3 months of active treatment and up to 2 days after the end of the study treatment, detection of alanine aminotransferase levels of three times te upper limit of the normal range or higher with or without bilirubin levels of two times the upper limit of the normal range or higher during follow-up, recurrent SVT, symtomatic VTE in other sites
    Mortalità totale e secondaria alla trombosi venosa splancnica,emorragie non definibili maggiori ma clinicamente rilevanti, incremento patologico delle transaminasi e/o della bilirubina, ricanalizzazione venosa, recidiva di trombosi venosa splancnica, trombosi venose in altri distretti
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months+ 2 days after the end of the study treatment
    3 mesi + 2 giorni dalla fine dello studio
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned13
    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 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
    LVLS
    LVLS
    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 months30
    E.8.9.1In the Member State concerned days90
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months30
    E.8.9.2In all countries concerned by the trial days30
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    All patients will continue to be followed up by the attending physicians according to local practice and therapeutic decisions will be left to the discretion of the attending clinician
    I pazienti continueranno ad essere seguiti dai medici responsabili del centro partecipante secondo normale pratica clinica e ogni successiva decisione terapeutica sarà lasciata allo stesso medico di riferimento.
    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 Decision2015-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-30
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