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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2012-000281-38
    Sponsor's Protocol Code Number:LEG-SIL-LTX-05
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-20
    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 number2012-000281-38
    A.3Full title of the trial
    A Randomized, Controlled Study To Investigate The Efficacy, Safety And Pharmacokinetics Of Legalon® Sil, Alone Or In Combination With Ribavirin, For The Prevention Of Recurrent Hepatitis C In Liver Transplant Recipients
    ESTUDIO ALEATORIZADO Y CONTROLADO PARA EVALUAR LA EFICACIA, SEGURIDAD Y FARMACOCINÉTICA DE LEGALON® SIL, EN MONOTERAPIA O EN COMBINACIÓN CON RIBAVIRINA, EN LA PREVENCIÓN DE HEPATITIS C RECURRENTE EN PACIENTES SOMETIDOS A TRASPLANTE HEPÁTICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate The Efficacy, Safety And Pharmacokinetics Of Legalon® Sil, Alone Or In Combination With Ribavirin, For The Prevention Of Recurrent Hepatitis C In Liver Transplant Recipients
    Estudio para evaluar la eficacia seguridad y la farmacocinética de Legalon® Sil solo o en combinarcióncon Rivarina para la prevención del la hepatitis C recurrente en transplantados de hígado.
    A.4.1Sponsor's protocol code numberLEG-SIL-LTX-05
    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 SponsorRottapharm
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRottapharm
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRottapharm
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street AddressVia Valosa di Sopra 7/9
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number+34917080376
    B.5.5Fax number+34917080387
    B.5.6E-mailmassimo.damato@rottapharm.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 Legalon SIL
    D.2.1.1.2Name of the Marketing Authorisation holderMadaus GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/828
    D.3 Description of the IMP
    D.3.1Product nameLegalon SIL
    D.3.4Pharmaceutical form Powder for solution for infusion
    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.3.8INN - Proposed INNSILIBININ-C-2´, 3-DIHYDROGEN SUCCINATE, DISODIUM SALT
    D.3.9.1CAS number 55254-34-7
    D.3.9.3Other descriptive nameSILIBININ-C-2´, 3-DIHYDROGEN SUCCINATE, DISODIUM SALT
    D.3.9.4EV Substance CodeSUB33890
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number528.5
    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 Rebetol
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd UK
    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.3.1Product nameRebetol
    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 INNRIBAVIRIN
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Recurrent Hepatitis C
    Hepatitis C recurrente
    E.1.1.1Medical condition in easily understood language
    Recurrent Hepatitis C
    Hepatitis C Recurrente
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10070678
    E.1.2Term Hepatitis C recurrent
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if a treatment with Legalon® SIL, alone or in combination with ribavirin, is effective in reducing the Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels down to undetectable, after Liver Transplantation (LT), in Chronic Hepatitis C patients undergoing LT.
    Determinar si el tratamiento con Legalon® SIL, en monoterapia o en combinación con ribavirina, es eficaz para reducir los niveles de ARN del VHC hasta niveles indetectables, tras TH en pacientes con hepatitis C crónica (HCC) sometidos a TH
    E.2.2Secondary objectives of the trial
    -To assess if a treatment with Legalon® SIL, alone or in combination with ribavirin, is effective on histological endpoints
    -To determine whether Legalon® SIL, alone or in combination with ribavirin, is able to induce other clinically significant virological responses
    -To assess if a treatment with Legalon® SIL, alone or in combination with ribavirin, is able to improve liver function during pre-LT period
    -To assess the safety and tolerability of Legalon® SIL, alone or in combination with ribavirin, including its potential effect on immunosuppressant agents
    -To assess the pharmacokinetics of silibinin hydrogen succinate A and B, silibinin A and B and ribavirin
    -To asses the liver concentrations of silibinin hydrogen succinate A and B and silibinin A and B
    -To asses Ex-Vivo plasma protein binding of silibinin hydrogen succinate A and B
    -Evaluar si el tratamiento con Legalon® SIL, en monoterapia o en combinación con ribavirina, es eficaz en los criterios de valoración histológicos.
    -Determinar si Legalon® SIL, en monoterapia o en combinación con ribavirina, es capaz de inducir otras respuestas virológicas clínicamente significativas.
    -Evaluar si el tratamiento con Legalon® SIL, en monoterapia o en combinación con ribavirina, es capaz de mejorar la función hepática durante el periodo previo al TH.
    -Evaluar la seguridad y tolerabilidad de Legalon® SIL, en monoterapia o en combinación con ribavirina, incluido su posible efecto sobre agentes inmunosupresores
    -Evaluar la farmacocinética de silibinina dihidrogenosuccinato A y B, silibinina A y B y ribavirina
    -Evaluar las concentraciones hepáticas de silibinina dihidrogenosuccinato A y B y silibinina A y B
    -Evaluar la unión a proteínas plasmáticas ex vivo de silibinina dihidrogenosuccinato A y B.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed and dated informed consent before undergoing any trial-related procedures
    2.Male or female patient aged between 18 and 70 years inclusive
    3.Patient with documented HCV infection
    4.Patient with a documented diagnosis of cirrhosis
    5.Patient placed on waiting list for liver transplantation
    6.Ability to communicate, participate, and comply with the requirements of the entire study [NB: patients that cannot afford the burden of daily visits to the center to receive the daily treatment before LT or patients with baseline characteristics (e.g. rare ABO and Rh blood groups) causing a low chance to receive a compatible graft within 42 days after randomization are eligible for the post-LT treatment only and can be randomized to Treatment Groups D or E].
    1.Consentimiento informado firmado y fechado, obtenido antes de cualquier procedimiento relacionado con el estudio
    2Varones o mujeres con edades comprendidas entre los 18 y 70 años, inclusive
    3.Paciente con infección diagnosticada por el VHC
    4.Paciente con diagnóstico documentado de cirrosis
    5.Paciente en lista de espera para un trasplante hepático
    6.Capacidad de comunicarse, participar y cumplir los requisitos de todo el estudio (NOTA: los pacientes que no puedan asumir la carga de las visitas diarias al centro para recibir el tratamiento antes del TH o los pacientes con características basales [p. ej., tales como grupo sanguíneo según tipificación ABO y factor Rh raros] que dan lugar a una probabilidad baja de recibir un trasplante compatible en un plazo de 42 días después de la aleatorización son aptos únicamente para el grupo de tratamiento posterior al TH y se les puede aleatorizar a los grupos de tratamiento D o E).
    E.4Principal exclusion criteria
    1.Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive)
    2.Active septic infections at time of screening
    3.Previous organ/tissue transplantation other than cornea and hair
    4.Patients requiring combined transplantation
    5.Use of systemic immunomodulators (including systemic corticosteroids) within 4 weeks of the screening visit or during the screening period
    6.Total bilirubin value >10mg/dL [Patients with total bilirubin value >10mg/dL are eligible to receive the post-LT treatment only, and therefore will be randomized to Treatment Groups F or G]
    7.Patients not eligible to be treated with ribavirin as per the instructions present in its prescribing information document
    8.For females of childbearing potential:
    -Pregnancy (i.e. positive pregnancy test at screening) or breast feeding
    -Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device (IUD), transdermal contraceptive patch).
    9.Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom
    10.Treatment for HCV with any investigational medication (prior use of silymarin is not exclusionary)
    11.Treatment for HCV with any licensed therapies or therapy with any interferon alpha within 30 days of the randomization visit
    12.Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study
    13.Any known pre-existing medical condition that could interfere with the listing of the patient or with his/her participation in and completion of the study, including but not limited to:
    -Chronic pulmonary disease (e.g. clinical chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis)
    -Current or history of any clinically significant cardiac abnormalities/dysfunction (e.g. angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension, or history of use of antianginal agents for cardiac conditions
    14.Site personnel directly involved in the study or their family members
    15.Known hypersensitivity to Legalon® SIL
    1.Coinfección por el virus de la inmunodeficiencia humana (VIH) o por el virus de la hepatitis B (HBsAg positivo)
    2.Infecciones sépticas activas en el momento de la selección
    3.Trasplante previo de órgano/tejido, excepto de córnea o pelo
    4.Pacientes que requieren un trasplante combinado
    5.Uso de inmunomoduladores sistémicos (incluidos corticosteroides sistémicos) en las 4 semanas previas a la visita de selección o durante el periodo de selección
    6.Valor de bilirrubina total > 10 mg/dl (los pacientes con un valor de bilirrubina total > 10 mg/dl únicamente son aptos para recibir tratamiento después del TH y, por lo tanto, serán aleatorizados a los grupos de tratamiento F o G)
    7.Pacientes no elegibles para tratamiento con ribavirina, según las instrucciones indicadas en el documento de información de prescripción
    8.En el caso de mujeres con capacidad reproductora:
    ?Mujeres embarazadas (es decir, prueba de embarazo positiva en la selección) o en periodo de lactancia
    ?Pacientes que no acepten la utilización de métodos anticonceptivos adecuados (p. ej., anticonceptivos orales, dispositivo intrauterino [DIU], parche anticonceptivo transdérmico).
    9.Pacientes varones no sometidos a vasectomía, que no acepten abstenerse de relaciones sexuales o que no utilicen preservativo
    10.Tratamiento para el VHC con cualquier fármaco en investigación (el uso previo de silimarina no supondrá un motivo de exclusión)
    11.Tratamiento para el VHC con cualquier tratamiento autorizado o cualquier tratamiento con interferón alfa en los 30 días anteriores a la visita de aleatorización
    12.Participación en otro estudio clínico en los 30 días previos a la aleatorización, o intención de participar en otro estudio clínico durante la participación en el estudio
    13.Cualquier afección médica preexistente que pudiera interferir en la inclusión del paciente en la lista de espera o con su participación y realización del estudio, incluidas, entre otras:
    ?Enfermedad pulmonar crónica (p. ej., enfermedad pulmonar obstructiva crónica clínica, enfermedad pulmonar intersticial, fibrosis pulmonar, sarcoidosis)
    ?Presencia o antecedentes de cualquier anomalía o disfunción cardíaca clínicamente significativa (p. ej., angina, insuficiencia cardíaca congestiva, infarto de miocardio, hipertensión pulmonar, cardiopatía congénita compleja, miocardiopatía, arritmia grave), incluida hipertensión actual no controlada, o antecedentes de uso de antianginosos para el tratamiento de cardiopatías
    14.Personal del centro directamente involucrado en el estudio o sus familiares
    15.Hipersensibilidad conocida a Legalon® SIL
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point is Complete Virological Response defined as undetectable HCV-RNA levels at the end of treatment with Legalon® SIL, alone or in combination with a standard dose of ribavirin.
    El punto final primario es de respuesta virológica completa definida como niveles de ARN-VHC indetectables al final del tratamiento con Legalon ® SIL, solo o en combinación con una dosis estándar de ribavirina
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment with Legalon SIL.
    For control group 4 weeks after LT
    Fin del tratamiento con Legalon SIL
    Para el grupo de control 4 semanas despues del TH
    E.5.2Secondary end point(s)
    -Liver histology evaluation 28 weeks after LT;
    -Liver fibrosis progression 28 weeks after LT;
    -Proportion of patients with a Complete Virological Response at end of study treatment, lasting for 4 weeks thereafter ? SVR4
    -Proportion of patients with a Complete Virological Response at end of study treatment, lasting for 12 weeks thereafter ? SVR12;
    -Proportion of patients with a Complete Virological Response at the end of study treatment, lasting for 24 weeks thereafter ? SVR24;
    -Proportion of patients with a Complete Virological Response at several time points during the course of the study;
    -Proportion of patients with a Partial Virological Response (at least 2 log10 drop in HCV-RNA) at several time points during the course of the study;
    -Proportion of patients with virological relapse;
    -Proportion of patients with virological breakthrough;
    -Proportion of patients with null response;
    -Effect of treatment on timing of antiviral therapy institution;
    -Normalization of Serum Alanine Aminotransferase (ALT) values, compared to baseline, at several time points during the course of the study;
    -Improvement of Serum Alanine Aminotransferase (ALT) values, compared to baseline, at several time points during the course of the study
    -Improvement of Liver Function during the pre-LT period
    Pharmacokinetic Endpoints
    -Silibinin hydrogen succinate A and B and silibinin A and B plasma concentrations will be determined during the first, the tenth, and the twenty-eighth day of treatment with Legalon® SIL, during both pre-LT and post-LT treatment, until 10h after the start of the infusion. Additional blood samples will be collected during the repeated dosing period, before drug administration. In patients belonging to Groups B, E, and G also RBV red blood cells and plasma concentrations will be determined. Urine concentrations for all drugs will be determined in 0-24h interval.
    -Silibinin hydrogen succinate A and B and silibinin A and B concentrations will be determined in liver specimens collected from the resected liver.
    -Plasma protein binding of silibinin hydrogen succinate A and B will be determined Ex Vivo.
    Safety endpoints:
    Analysis of standard routine safety endpoints such as: Adverse Events (AEs), Laboratory determinations, Vital signs, Physical examination and ECG.
    In addition blood levels of immunosuppressants and presence and persistence of treatment resistant viral species will be assessed
    -Evaluación de la histología hepática 28 semanas después de TH
    -Progresión de la fibrosis hepática 28 semanas después de la TH
    -Proporción de pacientes con una respuesta virológica completa al final del tratamiento de estudio , con una duración de 4 semanas a partir de entonces - SVR4
    -Proporción de pacientes con una respuesta virológica completa al final del tratamiento de estudio , con una duración de 12 semanas a partir de entonces - SVR12
    -Proporción de pacientes con una respuesta virológica completa al final del tratamiento del estudio , con una duración de 24 semanas a partir de entonces - SVR24
    -Proporción de pacientes con una respuesta virológica completa en varios momentos durante el estudio
    -Proporción de pacientes con una respuesta virológica parcial ( al menos 2 log10 caída de VHC - ARN ) en varios puntos de tiempo durante el curso del estudio
    -Proporción de pacientes con recaída virológica
    -Proporción de pacientes con avance virológico
    -Proporción de pacientes con respuesta nula
    -Efecto del tratamiento en el momento de la institución de la terapia antiviral
    -La normalización de suero de alanina aminotransferasa (ALT) los valores , en comparación con el valor basal , en varios momentos durante el curso del estudio
    -Mejora de los valores séricos de alanina aminotransferasa (ALT ), en comparación con el valor basal , en varios momentos durante el curso del estudio
    -Mejora de la función hepática durante el período pre -TH
    Las concentraciones plasmáticas B Silibinin hidrógeno succinato de A y B y silibinina A y se determinarán durante el primero, el décimo y el vigésimo octavo día de tratamiento con Legalon ® SIL, tanto durante la pre-TH y el tratamiento post-TH, hasta 10h después del inicio de la infusión. Muestras de sangre adicionales serán recogidos durante el período de administración de dosis repetidas, antes de la administración del fármaco. En pacientes pertenecientes a los Grupos B, E y G también RBV se determinarán las globulos rojos de la sangre y las concentraciones plasmáticas. Concentraciones de orina de todos los medicamentos serán determinadas en el intervalo de 0-24h.
    - Las concentraciones de B silibinina hidrógeno succinato de A y B y silibinina A y se determinaron en muestras de hígado recogidas desde el hígado extirpado.
    - Unión a proteínas plasmáticas de silibinina hidrógeno succinato de A y B se determinará ex vivo.
    Criterios de valoración de seguridad:
    Análisis de los criterios de valoración de seguridad de rutina estándar, tales como: eventos adversos (EA), determinaciones de laboratorio, signos vitales, examen físico y ECG.
    En los niveles de sangre además de los inmunosupresores y la presencia y persistencia de las especies virales resistentes a tratamiento se evaluará
    E.5.2.1Timepoint(s) of evaluation of this end point
    at different time points during the study
    en diferentes puntos de tiempo durante el estudio
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standar inmunosuppresive care
    E.8.2.4Number of treatment arms in the trial7
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Last Follow-up visit of the Last Patient
    Ultima Visita de seguimiento del ultimo paciente
    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 months9
    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 months9
    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) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 156
    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 patient will be given the normal treatment for this condition according to the current clinical practice
    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 Decision2014-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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-Sun May 05 17:35:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA