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    Summary
    EudraCT Number:2011-004695-11
    Sponsor's Protocol Code Number:AI452-020
    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:2013-06-13
    Trial results View 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 number2011-004695-11
    A.3Full title of the trial
    A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered with Telaprevir in Subjects with Genotype-1 Chronic Hepatitis C who are Treatment-naïve or Relapsed on Treatment with Peginterferon Alfa and Ribavirin
    Revised Protocol Number: 01 - Incorporates Amendment: 02
    Lambda-1a y Ribavirina en comparación con Peginterferón Alfa-2a y Ribavirina, cada uno de ellos administrado con Telaprevir, en sujetos con Hepatitis C crónica de genotipo-1 que no han recibido tratamiento con anterioridad o han sufrido una recidiva tras un tratamiento previo con Peginterferón Alfa y Ribavirina
    Número de protocolo revisado: 01-Incorpora la enmienda: 02
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
    Estudio fase 3, enmascarado y aleatorizado de Peginterferón Lambda-1a y Ribavirina en comparación con Peginterferón Alfa-2a y Ribavirina
    A.4.1Sponsor's protocol code numberAI452-020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01598090
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 No
    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 namePegylated Interferon Lambda
    D.3.2Product code BMS-914143 / PEG-rIL-29 / PEG IFN-?1
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGYLATED INTERFERON LAMBDA
    D.3.9.2Current sponsor codeBMS-914143
    D.3.9.4EV Substance CodeSUB31655
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Ribasphere
    D.2.1.1.2Name of the Marketing Authorisation holderThree Rivers Pharmaceuticals, LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRibasphere
    D.3.2Product code J05AB04
    D.3.4Pharmaceutical form 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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 namePegasys
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Incivo
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    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 INNTELAPREVIR
    D.3.9.1CAS number 402957-28-2
    D.3.9.3Other descriptive nameTELAPREVIR
    D.3.9.4EV Substance CodeSUB31651
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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
    Chronic Hepatitis C Virus (HCV) Infection (Genotype-1)
    Hepatitis C crónica de genotipo-1
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C
    Hepatitis C crónica
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telapravir.
    El proposito del estudio es determinar si con un régimen de Lambda combinado con RBV y TVR (Lambda/RBV/TVR) dará como resultado una eficacia comparable y una mejor tolerabilidad que el tratamiento con alfa-2a/RBV/TVR en sujetos que no han recibido tratamiento previo y pacientes que han sufrido una recidiva, con infección crónica por hepatitis C (VHC) de genotipo-1 (GT-1) en ambos casos.
    E.2.2Secondary objectives of the trial
    Not applicable
    NA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific
    (dated 05-Apr-12, version 1.0)

    The objective of this Amendment is to permit the collection and storage
    of blood samples for use in future exploratory pharmacogenetic
    research. Bristol-Myers Squibb will use DNA obtained from the blood
    sample and health information collected from the main clinical trial,
    AI452020 to study the association between genetic variation and drug
    response. Bristol-Myers Squibb may also use the DNA to study the
    causes and further progression of Hepatitis C infection. Samples from
    this study may also be used in conjunction with pharmacogenetic
    research results from other clinical studies to accomplish this objective.
    Enmienda sobre muestras de sangre para farmacogenética
    Número 01 - Específica de centro
    (05-apr-12, v. 1. 0
    El objetivo de esta enmienda es permitir la recogida y la conservación de muestras de sangre para uso en estudios de investigación farmacogenética exploratorios futuros. Bristol-Myers Squibb usará el ADN obtenido de la muestra de sangre y la información de salud recogida del cuaderno de recogida de datos del ensayo clínico principal, AI452020 para estudiar la asociación entre la variación genética y la respuesta a los medicamentos. BMS también puede usar el ADN para estudiar las causas y progresión adicional de la hepatitis C. Para conseguir este objetivo pueden usarse conjuntamente muestras de este y otros estudios de investigación farmacogenética.
    E.3Principal inclusion criteria
    ?Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
    ?Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]
    ?Relapsers, defined as subjects who had HCV RNA < LLOQ, target not detected at end of treatment with a prior alfa/RBV regimen and a HCV RNA ? LLOQ during the follow-up period after treatment. Capped at 20%
    ?HCV RNA ? 100,000 IU/mL
    ?Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
    ?Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
    ?Men or women, 18-70 years of age

    For additional inclusion criteria, please refer to Protocol section 3.3.1
    Sujetos con infección crónica por VHC de los subtipos GT-1a o GT-1b (La población sin tratamiento previo con el subtipo GT-1b se limitará al 50% aproximadamente)
    -Sujetos que no hayan recibido una terapia previa anti-VHC (basada en IFN y antivirales de acción directa [AAD]) O
    -Sujetos que han sufrido una recidiva, definidos como sujetos que tuvieron un ARN del VHC < LIDC, objetivo no detectado al final del tratamiento con un régimen previo de alfa/RBV y un ARN del VHC ? LIDC durante el periodo de seguimiento después del tratamiento. No se excluirán a los sujetos que han sufrido una recidiva que han sido tratados con anterioridad con Lambda. La población de sujetos que han sufrido una recidiva se limitará al 20% aproximadamente.
    -Carga viral del ARN del VHC ? 100.000 UI/ml en la selección, detectada por CPR
    -Sujetos con cirrosis compensada o no cirróticos infectados de manera crónica por VHC documentado por:
    ?Anticuerpos anti-VHC positivos, ARN del VHC o una prueba de genotipo del VHC positiva al menos 6 meses antes de la selección, o
    ?Biopsia hepática compatible con una infección crónica por VHC (signos de fibrosis y/o inflamación)
    La población cirrótica se limitará al 10% aproximadamente.
    -Hombres y mujeres mayores de 18 años
    Para ver otros criterios de inclusión referirse seccion 3. 3.1 del protocolo
    E.4Principal exclusion criteria
    ?Chronic liver disease due to causes other than chronic HCV
    ?Current or past evidence of decompensation
    ?Conditions that preclude the use of Alfa/RBV/TVR per respective labels
    ?Diagnosed or suspected hepatocellular carcinoma

    For additional exclusion criteria, please refer to Protocol section 3.3.2
    a)Infección con VHC diferente a los subtipos GT-1a y GT-1b
    b)Prueba positiva para HBsAg o anticuerpos anti-VIH-1/VIH-2 en la selección
    c)Pruebas de una enfermedad médica asociada a hepatopatía crónica distinta del VHC (entre otras: hemocromatosis, hepatitis autoinmune, enfermedad hepática alcohólica, enfermedad biliar, esteatosis hepática no alcohólica y exposición a toxinas).
    d)Exposición previa al tratamiento con AAD o con agentes experimentales para el VHC
    e)Exposición previa al tratamiento basado en IFN (excluyendo los que han sufrido una recidiva)
    f)Para ver otros criterios de inclusión referirse seccion 3. 3.2 del protocoloCualquier criterio que impida al sujeto recibir el tratamiento con alfa-2a, RBV o TVR


    Para ver otros criterios de Exclusión referirse seccion 3. 3.2 del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    (Please note that only part B of the study will be conducted in the EU)
    Proportion of subjects achieving efficacy as measured by Sustained Virologic Response at post-treatment Week12 (SVR 12) defined as HCV RNA < LLOQ
    En Europa solo se llevará a cabo la parte B del estudio.
    Proporción de sujetos que alcanzan la eficacia medida por la RVM12, definida como ARN del VHC < LIDC (objetivo detectado o no detectado), en la semana 12 del seguimiento postratamiento de Lambda/RBV/TVR y con alfa-2a/RBV/TVR en sujetos que no han recibido tratamiento previo o que han sufrido una recidiva durante la terapia previa con alfa/RBV
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-treatment Week 12
    Post tratamiento semana 12
    E.5.2Secondary end point(s)
    - Proportion of subjects who achieve efficacy as measured by SVR12, defined as hepatitis C virus (HCV) RNA < LLOQ in treatment-naive subjects
    Time Frame: Post-treatment Week 12
    - Proportion of subjects who achieve efficacy as measured by eRVR, defined as HCV RNA < LLOQ
    Time Frame: On-treatment Week 4 and Week 12
    - Proportion of subjects who achieve efficacy as measured by SVR 24, defined as HCV RNA < LLOQ
    Time Frame: Post-treatment Week 24
    - Number of incidence for Cytopenic abnormalities (anemia is defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3, thrombocytopenia as defined by platelets < 50,000 mm3)
    Time Frame: Up to 48 weeks
    - Number of incidence for Flu-like symptoms (as defined by pyrexia or chills or pain)
    Time Frame: Up to 48 weeks
    - Number of incidence for Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
    Time Frame: Up to 48 weeks
    ?Proporción de sujetos que alcanzan la eficacia medida por RVM12, definida como ARN del VHC < LIDC (objetivo detectado o no detectado), en la semana 12 de seguimiento postratamiento en sujetos que no han recibido tratamiento previo
    ?Proporción de sujetos que alcanzan la eficacia medida por RVRp, definida como ARN del VHC < LIDC en las semanas 4 y 12 del tratamiento.
    ?Proporción de sujetos que alcanzan la eficacia medida por RVM24, definida como ARN del VHC < LIDC (objetivo detectado o no detectado), hasta la semana 24
    ?Número de incidencias de síntomas musculoesqueléticos (definidos por artralgia, mialgia o dolor de espalda) hasta la semana 48
    ?Número de incidencias de síntomas similares a la gripe (definidos por fiebre, escalofríos o dolor) hasta la semana 48
    ?Anomalías citopénicas (la anemia se define por Hg < 10 g/dl, neutropenia definida por RAN < 750/mm3, trombocitopenia definida por plaquetas < 50.000/mm3) hasta la semana 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2
    ?Ver sección E.5.2
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers; Outcomes Research; Immunogenicity
    Biomarcadores, resultados de investigación; inmunogenicidad
    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) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    Switzerland
    United Kingdom
    United States
    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
    ULTIMA VISITA ULTIMO PACIENTE
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 598
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 246
    F.4.2.2In the whole clinical trial 629
    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)
    At the end of the study, BMS will not continue to supply study drug to subjects/investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    Al final del estudio, BMS no seguirá suministrando fármaco del estudio a los sujetos / investigadores a menos BMS decida extender el estudio. El investigador debe asegurarse de que el sujeto recibe estándar adecuado de atención para el tratamiento de la enfermedad en estudio.
    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 Decision2013-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-04
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