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    Summary
    EudraCT Number:2007-005508-42
    Sponsor's Protocol Code Number:P05216
    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:2008-07-04
    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 number2007-005508-42
    A.3Full title of the trial
    "Estudio Fase 3 de Seguridad y Eficacia de Boceprevir en Pacientes con Hepatitis C Crónica Genotipo 1 No Tratados Previamente."

    "A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1."
    A.4.1Sponsor's protocol code numberP05216
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSchering-Plough Research Institute, a Division of Schering Corporation
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameBoceprevir
    D.3.2Product code SCH 503034
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBoceprevir
    D.3.9.2Current sponsor codeSCH 503034
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Plough Europe
    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 namePegIntron
    D.3.2Product code SCH 54031
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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-2b
    D.3.9.1CAS number 215647-85-1
    D.3.9.2Current sponsor codeSCH 54031
    D.3.9.3Other descriptive namePegIntron
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 holderSchering Plough Europe
    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.3.2Product code SCH 18908
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeSCH 18908
    D.3.9.3Other descriptive nameRebetol
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Plough Europe
    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 namePegIntron
    D.3.2Product code SCH 54031
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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-2b
    D.3.9.1CAS number 215647-85-1
    D.3.9.2Current sponsor codeSCH 54031
    D.3.9.3Other descriptive namePegIntron
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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: 5
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Plough Europe
    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 namePegIntron
    D.3.2Product code SCH 54031
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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-2b
    D.3.9.1CAS number 215647-85-1
    D.3.9.2Current sponsor codeSCH 54031
    D.3.9.3Other descriptive namePegIntron
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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: 6
    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 PegIntron
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Plough Europe
    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 namePegIntron
    D.3.2Product code SCH 54031
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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-2b
    D.3.9.1CAS number 215647-85-1
    D.3.9.2Current sponsor codeSCH 54031
    D.3.9.3Other descriptive namePegIntron
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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*
    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
    Hepatítis C Crónica.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo primerio de este estudio es comparar la eficacia de dos regímenes terapéuticos de boceprevir a una dosis de 800 mg tres veces por día (TID) vía oral (PO) (en adelante denominado boceprevir) en combinación con PegIntrón 1.5 µg/kg semanalmente (QW) vía subcutánea (SC) más ribavirina dosificada según peso (WBD) (de 600 mg/día a 1400 mg/día) vía oral (PO) (en adelante denominado PEG + RBV [WBD]) frente a una terapia sólo de PEG + RBV [WBD] en sujetos adultos no tratados con hepatítis C crónica (HCC).
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de ambas partes del estudio son:
    • Evaluar la seguridad de boceprevir cuando se administra junto a PEG + RBV (WBD).
    • Definir los factores de predicción de la respuesta virológica sostenida (SVR) tales como factores epidemiológicos, características de la enfermedad y respuesta al tratamiento.
    • Desarrollar una relación entre el estado estacionario de los parámetros farmacocinéticos, obtenidos de la población basada en un modelo farmacocinético y las respuestas de un subgrupo de sujetos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnóstico y Criterios de Inclusión: Se elegirán para este estudio sujetos adultos con Hepatítis C Crónica (HCC) VHC genotipo 1 que no hayan recibido tratamiento previo para la HCC.
    Los sujetos deben cumplir TODOS los criterios detallados a continuación para participar:
    Criterios de Inclusión para HCC:
    1. Los sujetos deben presentar una infección de HCC genotipo 1 documentada. Los resultados del ARN-VHC obtenidos en el laboratorio central en la visita de selección deben confirmar el genotipo 1 de la infección y debe ser ≥10,000 IU/mL.
    2. Los sujetos deben tener una biopsia de hígado con histología consecuente con Hepatitis C Crónica sin ninguna otra etiología. Copias del informe de patología y las muestras de histología se requieren para la inclusión del paciente en el estudio. Las muestras de histología y el informe de patología deben estar disponibles en el centro antes de la randomización del sujeto. Son preferibles dos muestras de tejido sin teñir; sin embargo, se aceptará una muestra teñida con hematoxilina-eosina (H&E) más una muestra teñida con Tricrómico de Masson's (Masson's trichrome), las muestras deberán ser revisadas por el investigador para confirmar que son adecuadas.
    a. No cirrosis: la biopsia debe estar realizada dentro de los 3 años anteriores a la Visita de Screening. Para las biopsias de más de 18 meses anteriores a la Visita de Screening se realizarán pruebas para marcadores de fibrosis para evaluar el nivel de fibrosis.
    b. Cirrosis: cualquier biopsia histórica que demuestre cirrosis será suficiente independientemente del tiempo que haya transcurrido desde la biopsia.
    c. A los sujetos cuya biopsia no cumpla estos criterios de tiempo se les podrá realizar una biopsia entre la Visita de Screening y el Día 1 una vez que las evaluaciones del screening confirmen que el sujecto cumple los criterios de inclusión.
    3. Los sujetos con fibrosis en puentes o cirrosis deben tener una ecografía realizada en los 6 meses previos a la Visita de Screening (o entre la Visita de Screening y el Día 1) sin hallazgos sospechosos de carcinoma hepatocelular (CHC).
    Criterios Generales de Inclusión:
    4. Los sujetos deben ser de 18 años de edad o mayores.
    5. Los sujetos deben pesar entre 40 kg y 125 kg.
    6. El sujeto y su pareja(s) deben acordar el uso de métodos anticonceptivos fiables tal y como se especifica en la Sección 7.6.1 del protocolo, durante al menos 2 semanas antes del Día 1 y continuar hasta al menos 6 meses después de la última dosis del medicamento del estudio, o durante más tiempo si así lo indica la legislación local.
    7. Los sujetos deben estar dispuestos a dar su consentimiento por escrito.

    E.4Principal exclusion criteria
    (Se resumen los principales)
    -Sujetos con co-infección conocida de VIH o virus de la hepatitis B (HBsAg positivo)
    o infectados con genotipos del VCH distintos del genotipo 1 (incluyendo genotipos mixtos).
    - Sujetos que recibieron tratamiento previo para la hepatitis C; que no fuesen remedios herbales exceptuando aquellos de los que se conoce su hepatotoxicidad (que son criterio de exclusión). Cualquier remedio herbal utilizado para el tratamiento de la hepatitis C debe suspenderse antes del Día 1. Sólo la silimarina (cardo mariano) está permitida durante el estudio.
    - El tratamiento con cualquier fármaco en investigación en los 30 días previos a la visita de randomización en este estudio.
    - La participación en otro ensayo clínico en los 30 días previos a la randomización, o la intención de participar en otro ensayo clínico durante la participación en este estudio.
    -Evidencia de enfermedad descompensada del hígado que incluya pero no se limite a historia de presencia de ascitis, varices hemorrágicas, o encefalopatía hepática.
    -Sujetos diabéticos o hipertensos con hallazgos en el examen ocular clínicamente significativos según se define en el protocolo.
    -Condición(es) psiquiátrica(s) pre-existente según se define en el protocolo
    -Diagnóstico clínico de drogodependencia según se define en el protocolo según tipo de sustancia y tiempo.
    -Como se define más adelante en el protocolo, cualquier condición médica pre-existente que pueda interferir en la participación y cumplimiento del paciente con el estudio, incluyendo pero no limitado a:
    a. Traume del Sistema Nervisos Central(SNC)
    b. Historia actual de ataques epilépticos
    c. Historia de ictus o ataque isquémico transitorio
    d. Enfermedad mediada inmunológicamente
    e. Enfermedad crónica pulmonar
    f. Historia cardíaca actual o cualquier anomalía o disfunción cardíaca significativa
    g.Cualquier condición médica que requiera, o sea probable que requiera, administración crónica sistémica de corticoesteroides durante el transcurso del estudio
    h.Gota clínicamente activa en el año previo
    i.Hemoglobinopatía
    j.Síndormes Mielodisplásicos
    k.Coagulopatía
    l.Transplante de órganos (incluyendo transplante de células hematopoyéticas) distinto de transplante de córnea y pelo
    m.Acceso venoso pobre que impida la recogida de muestras de sangre periférica de rutina que se requieren para este estudio
    n.Sujetos con un catéter intravenoso permanente
    o.Sujetos con historia de cirugía gástrica (ej. grapas, bypass) o sujetos con historia de desórdenes de malabsorción
    -Evidencia de cancer o sospecha de cancer, o historia de cancer dentro de los 5 años anteriores (excepto carcinoma basal in situ o carcinoma de células de la piel tratado adecuadamente). Sujetos bajo evaluación por sospecha de cancer no son elegibles.
    -Sujetos que estén embarazadas o amamantando.Sujetos con intención de quedar embarzadas durante el periodo del estudio.Hombres cuya pareja esté o tenga intención de quedarse embarazada durante el perido del estudio
    -Criterios hematológicos, bioquímicos, y serológicos (no se podrán utilizar factores de crecimiento para alcanzar los requerimientos para la entrada en el estudio):
    a.hemoglobina <12g/dL para mujeres y <13 g/dL para hombres
    b.Neutrófilos <1500/mm3 (personas de raza negra:<1200/mm3)
    c.Plaquetas <100.000/mm3
    d.Bilirrubina Directa >1.5 por encima del límite normal (ULN) del rango de referencia del laboratorio. Bilirrubina Total >1.6 mg/dL a no ser que el paciente tenga historia de Enfermedad de Gilbert. Si la enfermedad de Gilbert es considerada la etilogía se debe documentar en la historia médica del paciente.
    -Glucosa sérica
    a. para sujetos no diagnosticados previamente de diabetes mellitus
    1). ≥140 mg/dL (no-en ayunas) a menos que HbA1c ≤7% O
    2). ≥100 mg/dL (en ayunas) a menos que HbA1c ≤7%
    b. Para sujetos diagnosticados previamente de diabetes, HbA1c >8.5%
    -PT (tiempo de protrombina)/PTT values >10% por encima del rango de referencia del laboratorio

    E.5 End points
    E.5.1Primary end point(s)
    El objetivo primario de eficacia es lograr una respuesta virológica sostenida (SVR) definida por una concentración plasmática indetectable de ARN-VHC en la semana 24 de la fase de seguimiento. Se declararán como fallos de tratamiento a aquellos sujetos que cumplan una de las siguientes características:
    • Sujetos en cualquier brazo de tratamiento que presenten ARN-VHC detectable en la semana 24 de la fase de seguimiento.
    • Sujetos en cualquier brazo de tratamiento que presenten ARN-VHC detectable en la semana 24 del tratamiento.
    • Sujetos en cualquier brazo de tratamiento a los que les falte la determinación de ARN-VHC en la semana 24 de la fase de seguimiento pero que presentase ARN-VHC detectable en la semana 12 de la fase de seguimiento.

    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 Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    interferon responses (RNA)
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Última visita del último paciente (Last Subject Last Visit).
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 2008-07-04. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1060
    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)
    A todos los pacientes que hayan recibido al menos una dosis de boceprevir se les ofrecerá la posibilidad de participar en un estudio de seguimiento a largo plazo de 3 años (P05063) tras completar su participación en este estudio. Los pacientes del brazo control con ARN-VHC detectable en la semana 24 de la fase de seguimiento serán elegibles para participar en un estudio de acceso expandido (P05514) y recibir boceprevir + PEG 1.5 mcg/kg/semana + RBV durante 44 semanas.

    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 Decision2008-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-19
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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