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    Summary
    EudraCT Number:2016-003240-37
    Sponsor's Protocol Code Number:TROMBOXABAN
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-003240-37
    A.3Full title of the trial
    Prospective, multicenter, randomized study to assess the effect of rivaroxaban in the portal vein thrombosis recanalization and the survival in patients with cirrhosis and portal vein thrombosis
    Estudio prospectivo multicéntrico, aleatorizado, para valorar el efecto de rivaroxaban en la recanalización de la trombosis venosa portal y en la supervivencia en pacientes con cirrosis y trombosis venosa portal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the effect of rivaroxaban in patients with advanced liver disease with portal vein thrombosis
    Estudio para evaluar el efecto del rivaroxaban en pacientes con enfermedad hepática en fase avanzada con trombosis portal
    A.3.2Name or abbreviated title of the trial where available
    TROMBOXABAN
    TROMBOXABAN
    A.4.1Sponsor's protocol code numberTROMBOXABAN
    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 SponsorFundación para la Investigación Biomédica Hospital Ramón y Cajal
    B.1.3.4CountrySpain
    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 supportCarlos III Health Institute (National Health System)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpanish Clinical Research Network
    B.5.2Functional name of contact pointMarta del Álamo
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Colmenar Km 9.100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913368825
    B.5.5Fax number+34913368825
    B.5.6E-mailmartadelalamo.hrc@gmail.com
    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®
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Liver cirrhosis and portal vein thrombosis
    Cirrosis hepática y trombosis de la vena porta
    E.1.1.1Medical condition in easily understood language
    Liver disease in advanced stage, with the possibility of developing portal vein thrombosis (occlusion of the vein that carries blood to the liver)
    Enfermedad hepática en fase avanzada, con posibilidad de desarrollar trombosis en la vena porta (oclusión de la vena que lleva la sangre al hígado)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Determine whether anticoagulation with rivaroxaban improved transplant free survival and hospital admissions for hepatic decompensation or significant bleeding complications without progression of thrombosis
    Determinar si la anticoagulación con rivaroxaban mejora la supervivencia libre de trasplante y de presentar ingresos hospitalarios por descompensación hepática o complicaciones hemorrágicas significativas y sin progresión de la trombosis
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy for recanalization of portal vein thrombosis.
    - To evaluate the efficacy to prevent decompensated cirrhosis complications of portal hypertension (ascites, spontaneous bacterial peritonitis, ruptured variceal haemorrhage or hepatorenal syndrome).
    - Evaluate the effectiveness in reducing the number of hospital admissions due to decompensated cirrhosis.
    - Evaluate the safety of withdrawal rate with rivaroxaban anticoagulant therapy due to adverse effects.
    - Assess the effect on hepatocellular function (Child-Pugh y MELD).
    - Assess the effect on inflammatory parameters and bacterial translocation.
    - Evaluar la eficacia para recanalizar la trombosis portal.
    - Evaluar la eficacia para prevenir la descompensación de la cirrosis por complicaciones de la hipertensión portal (ascitis, peritonitis bacteriana espontánea, hemorragia por rotura de varices o síndrome hepatorrenal).
    - Evaluar la eficacia para reducir el número de ingresos hospitalarios por descompensación de la cirrosis.
    - Evaluar la seguridad de tasa de abandono de la terapia anticoagulante con rivaroxaban por efectos adversos.
    - Evaluar el efecto sobre la función hepatocelular (Child-Pugh y MELD).
    - Evaluar el efecto sobre los parámetros inflamatorios y de traslocación bacteriana.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-75 years.
    - Hepatic cirrhosis.
    - Thrombosis splenoportal axis: 1) >25% on any of the three main vessels (the main trunk of the portal vein, superior mesenteric vein, splenic vein) 2) Thrombosis affects > 50% of at least one of the intrahepatic branches.
    - Nonterminal Hepatic failure: B7-C12 state in Child-Pugh classification.
    - Edad 18-75 años.
    - Cirrosis hepatica.
    - Trombosis del eje esplenoportal: 1) cualquiera de los tres vasos mayores (tronco principal de la vena portal, vena mesentérica superior, vena esplénica) aislado >25%, 2) afectación >50% de al menos una de las ramas intrahepáticas.
    - Insuficiencia hepática no terminal: estadio B7-C12 de la clasificación de Child-Pugh.
    E.4Principal exclusion criteria
     Thrombosis: <25% of a single vessel of the splenoportal axis.
     Patient on the waiting list or evaluation for liver transplantation.
     Portal cavernoma (chronic and complete occlusion of the portal vein accompanied by a network of small venous vessels).
     Antiplatelet and/or anticoagulant therapy at the time of inclusion.
     Platelet count equal or less than 30,000 platelets/mm3.
     Renal failure (creatinine clearance <15 ml/min).
     Severe or terminal liver failure (≥ 13 points Child-Pugh classification).
     Active intra or extrahepatic neoplasia.
     Clinically significant active bleeding.
     Alcohol consumption ≥ 60 g/day in men and ≥ 40 g/day in women.
     Pregnancy- lactation
     Trombosis aislada <25% de un sólo vaso del eje esplenoportal.
     Paciente en lista de espera o en evaluación para trasplante hepático.
     Cavernoma portal (oclusión crónica y completa de la vena porta acompañada de una red de pequeños vasos venosos en su trayecto).
     Tratamiento con anticoagulantes y/o antiagregantes en el momento de la inclusión.
     Recuento plaquetario igual o inferior a 30.000 plaquetas/mm3.
     Insuficiencia renal (aclaramiento < 15 ml/min).
     Insuficiencia hepática grave o terminal (≥ 13 puntos de la clasificación de Child-Pugh).
     Neoplasia intra o extrahepática activa.
     Hemorragia activa clínicamente significativa.
     Consumo de alcohol ≥ 60 gramos/día en varones y ≥ 40 gramos/día en mujeres.
     Embarazo- lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Transplant free survival, without hospital admissions due to liver decompensation or significant bleeding complications, without thrombosis progression
    Supervivencia libre de trasplante, sin ingresos hospitalarios por descompensación hepática o por complicaciones hemorrágicas significativas, sin progresión de la trombosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each visit
    En cada visita.
    E.5.2Secondary end point(s)
    - Significant bleeding from any cause.
    - Cirrhosis complications requiring hospital admission (ascites, hemorrhage, Hepatic encephalopathy grade II or higher).
    - Progression of portal thrombosis.
    - Hemorragia significativa por cualquier causa.
    - Complicaciones de la cirrosis que requieran ingreso hospitalario (ascitis, episodio de hemorragia por cualquier causa, encefalopatía hepática grado II o superior).
    - Progresión de la trombosis portal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each visit
    En cada visita
    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) 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 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 concerned12
    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
    LVLS
    El estudio finalizará cuando el último paciente realice la última visita
    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 days
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 No
    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 state134
    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
    ninguno
    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 Spanish Clinical Research Network (SCReN)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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