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    Summary
    EudraCT Number:2007-005151-42
    Sponsor's Protocol Code Number:P05101
    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:2008-07-22
    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 number2007-005151-42
    A.3Full title of the trial
    "Estudio fase 3 de Seguridad y Eficacia de Boceprevir en pacientes con Hepatitis C Crónica genotipo 1 que recayeron tras el tratamiento previo con Peginterferón/Ribavirina".

    "A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin".
    A.4.1Sponsor's protocol code numberP05101
    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, una División de 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.3.2Product 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 Information not present in EudraCT
    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.2.1.2Country 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 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 Information not present in EudraCT
    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: 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 Information not present in EudraCT
    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 principal de este estudio consiste en comparar la eficacia de dos pautas de tratamiento con boceprevir (800 mg tres veces al día [t.v.d.] por vía oral [v.o.]) (en adelante denominado boceprevir) en asociación con PegIntron® (1,5 μg/kg una vez por semana [u.v.s.] por vía subcutánea [s.c.]) y ribavirina en dosis ajustada al peso (d.a.p.) (de 600 mg/día a 1400 mg/día) v.o. (en adelante denominado PEG + RBV [d.a.p.]) con el tratamiento con PEG + RBV (d.a.p.) solos en adultos con hepatitis crónica C (HCC) de genotipo 1 que han demostrado capacidad de respuesta al interferón y en los que ha fracasado el tratamiento previo con peginterferón y ribavirina.
    E.2.2Secondary objectives of the trial
    1) Evaluar la seguridad del boceprevir cuando se utiliza en asociación con PEG + RBV (d.a.p.)

    2) Definir los factores pronósticos de respuesta viral sostenida (RVS), tales como los factores epidemiológicos, las características de la enfermedad y la respuesta durante el tratamiento.

    3) Determinar la relación entre los parámetros farmacocinéticos en estado de equilibrio (obtenidos de un modelo farmacocinético poblacional) y las respuestas de un subgrupo de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios de inclusión para los pacientes con HCC y capacidad de respuesta al interferón en los que ha fracasado el tratamiento:

    1. Para participar en el estudio, los pacientes deben haber recibido un tratamiento que posibilite su inclusión, es decir: peginterferón α2a y ribavirina o peginterferón α2b y ribavirina durante 12 semanas como mínimo. Si un paciente ha recibido más de un tratamiento que cumpla estos requisitos, se considerará que el que posibilita su inclusión es el más reciente.
    Nota: Se admite el tratamiento de mantenimiento con cualquier interferón α tras el fracaso del que posibilita su inclusión; no obstante, el tratamiento de mantenimiento debe suspenderse un mes antes de la visita de selección.

    2. Durante el tratamiento que posibilite su inclusión, los pacientes deben presentar:
    i. niveles indetectables de ARN-VHC documentados en los 30 días siguientes al final del tratamiento (FdT) y ARN-VHC detectable posteriormente durante el seguimiento O
    ii. una reducción ≥2 log10 del ARN-VHC confirmada antes del final de la 12ª semana de tratamiento (ST).
    Nota: en el caso de los pacientes que no han participado en protocolos del Schering-Plough Research Institute (SPRI), los informes virológicos y la documentación del tratamiento previo que posibilite su inclusión deben anonimizarse por completo y enviarse por fax al médico del proyecto designado por el promotor para comprobar que son aptos para participar en este estudio.

    3. El paciente debe presentar infección por VHC de genotipo 1 ya confirmada. Los pacientes con otros genotipos o genotipos mixtos no son válidos. El resultado del ARN-VHC obtenido por el laboratorio central en la visita de selección debe confirmar la infección por genotipo 1 y debe ser ≥10.000 UI/ml.

    4. La biopsia hepática del paciente debe presentar una histología compatible con HCC y con ninguna otra etiología. Para la inclusión del paciente en el estudio se requieren copias del informe anatomopatológico y preparaciones histológicas. El centro del estudio debe disponer del informe anatomopatológico y las preparaciones antes de la aleatorización del paciente.
    Son preferibles dos preparaciones sin teñir, aunque se aceptará una preparación teñida con hematoxilina-eosina (H-E) y otra teñida con tricrómico de Masson (el investigador debe revisar las preparaciones para comprobar que son adecuadas). La revisión del anatomopatólogo central tendrá fines analíticos.
    a. Sin cirrosis: la biopsia debe haberse realizado en los 3 años previos a la visita de selección; en las biopsias realizadas más de 18 meses antes de la visita de selección, se realizará un análisis de marcadores de fibrosis para valorar el grado de ésta.
    b. Cirrosis: se aceptará cualquier biopsia hepática previa en la que se observe cirrosis, sea cual sea su antigüedad.

    En el Apéndice 1 se incluyen diversos sistemas de valoración de la fibrosis hepática.
    c. Los pacientes cuya biopsia hepática no cumpla los requisitos de antigüedad indicados pueden someterse a una biopsia hepática entre la visita de selección y el día 1 si en la visita de selección se confirma que cumplen los criterios de inclusión en el estudio.

    5. Los pacientes con fibrosis en puentes o cirrosis deben disponer de una ecografía realizada en los 6 meses previos a la visita de selección (o entre la visita de selección y el día 1) en la que no se observen indicios de carcinoma hepatocelular (CHC).

    6. Los pacientes que participen en los protocolos de mantenimiento P02570 o P02569 de SPRI deben haber finalizado el estudio para poder ser incluidos en éste.
    Criterios generales de inclusión:

    7. Los pacientes deben tener ≥18 años de edad.

    8. Los pacientes deben pesar de 40 a 125 kg.

    9. El paciente y su(s) pareja(s) deben comprometerse a utilizar métodos anticonceptivos aceptables (los indicados en la sección 7.6.1) desde 2 semanas antes del día 1 como mínimo y continuar utilizándolos al menos hasta 6 meses después de la última dosis de la medicación del estudio, o más si lo exige la normativa local.

    10. Los pacientes deben estar dispuestos a dar su consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Pacientes con coinfección conocida por el virus de la inmunodeficiencia humana (VIH) o el virus de la hepatitis B (HBsAg positivo).
    2. Pacientes en los que se ha suspendido el tratamiento previo con peg/rbv por un acontecimiento adverso considerado por el investigador posible o probablemente relacionado con peg/rbv.
    3. Tratamiento con ribavirina en los 90 días previos a la visita de selección o con cualquier interferón α en el mes previo.
    4. Tratamiento de la hepatitis C con algún medicamento en investigación. Tratamiento previo con productos de fitoterapia de hepatotoxicidad conocida. Todo producto de fitoterapia administrado para el tratamiento de la hepatitis C, excepto la silimarina (cardo mariano), debe suspenderse antes del día 1.
    5. Tratamiento con algún fármaco en investigación en los 30 días previos a la visita de aleatorización del estudio.
    6. Participación en cualquier otro ensayo clínico en los 30 días previos a la aleatorización o intención de participar en otro ensayo clínico durante la participación en este estudio.
    7. Indicios de hepatopatía descompensada.
    8. Pacientes diabéticos o hipertensos con alteraciones clínicamente significativas en la exploración oftalmológica descritas en el protocolo.
    9. Trastorno(s) psíquico(s) previo(s) como los descritos en el protocolo.
    10. Diagnóstico clínico de abuso de las drogas descitas en el protocolo en los periodos establecidos.
    11. Todo trastorno médico previo conocido que pueda afectar a la participación del paciente en el estudio y su finalización, como: traumatismo del sistema nervioso central (SNC), antecedentes o presencia actual de trastorno convulsivo, antecedentes de ictus o accidente isquémico transitorio, enfermedad de origen inmunitario, neumopatía crónica, antecedentes o presencia actual de alteración o disfunción cardiaca clínicamente significativa, todo trastorno médico que precise (o sea probable que precise) la administración sistémica crónica de corticosteroides en el transcurso del estudio, gota clínica activa en el último año, hemoglobinopatía como, entre otras, la talasemia mayor, síndromes mielodisplásicos, coagulopatía, trasplantes de órganos, mal acceso venoso que impida la extracción habitual de sangre periférica necesaria para este estudio, catéteres venosos permanentes, antecedentes de cirugía gástrica o antecedentes de trastornos de la absorción.
    12. Signos de cáncer activo, sospecha de cáncer o antecedentes de cáncer en los últimos 5 años.
    13. Mujeres gestantes o en periodo de lactancia. Mujeres que tengan intención de quedarse embarazadas en el transcurso del estudio. Pacientes cuyas parejas estén o tengan intención de quedarse embarazadas en el transcurso del estudio.
    14. Cualquier otro trastorno que, en opinión de un médico, impida la inclusión del paciente o pueda afectar a su participación en el estudio y a la finalización de éste.
    15. Pacientes que formen parte del personal del centro que está directamente involucrado en este estudio.
    16. Pacientes que sean familiares del personal del estudio.
    17. Pacientes que experimenten un acontecimiento adverso grave (AAG) potencialmente mortal durante el periodo de selección.
    Criterios analíticos de exclusión: Nota: Si se cumple alguno de los criterios analíticos de exclusión, el centro tendrá que repetir el análisis al paciente, tal y como se describe en el protocolo.
    18. Criterios hematológicos, bioquímicos y serológicos: hemoglobina (Hgb) <12 g/dl en mujeres y <13 g/dl en varones; neutrófilos <1500/mm³ (negros <1200/mm³); plaquetas <100.000/mm³; bilirrubina directa >1,5 x límite superior de normalidad (LSN) del intervalo de referencia del laboratorio; bilirrubina total >1,6 mg/dl, salvo si el paciente presenta antecedentes de enfermedad de Gilbert (en ese caso debe documentarse en la historia del paciente).
    19. Albúmina sérica < límite inferior de normalidad (LIN) del intervalo de referencia del laboratorio.
    20. Tirotropina (TSH) >1,2 x LSN o <0,8 x LIN del intervalo de referencia del laboratorio, con la siguiente excepción: el paciente puede participar si es clínicamente eutiroideo Y la normalidad de la función tiroidea se confirma mediante determinación de tiroxina y triyodotironina (T4 y T3).
    21. Creatinina sérica >LSN del intervalo de referencia del laboratorio.
    22. Glucosa sérica: en pacientes sin diagnóstico previo de diabetes mellitus >140 mg/dl (no en ayunas) salvo si la hemoglobina de subtipo A1c (HbA1c) es ≤7%, O >100 mg/dl (en ayunas) salvo si HbA1c ≤7%; en pacientes con diagnóstico previo de diabetes mellitus: HbA1c >8,5%.
    23. Tiempo de protrombina (TP) y tiempo parcial de tromboplastina (TPT) >10% por encima del intervalo de referencia del laboratorio.
    24. Anticuerpos antinucleares (ANA) >1:320.
    25. Alfafetoproteína (AFP): AFP >100 ng/ml O si la AFP = 50-100 ng/ml será necesario realizar una ecografía hepática, excluyéndose a los pacientes que presenten hallazgos sospechosos de CHC.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es la RVS, definida como la indetectabilidad de ARN-VHC en plasma en la 24ª semana de seguimiento (SS). Si un paciente carece de datos de la SS 24 y presenta ARN-VHC indetectable en la SS 12, se considerará que ha logrado una RVS. Se considerarán fracasos terapéuticos los siguientes casos:

    • Pacientes de cualquier grupo de tratamiento con ARN-VHC detectable en la SS 24.
    • Pacientes de cualquier grupo de tratamiento con ARN-VHC detectable en la ST 12.
    • Pacientes de cualquier grupo de tratamiento sin datos de ARN-VHC en la SS 24 y ARN-VHC detectable en la SS 12.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 sujeto (LSLV - 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 2008-07-22. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 375
    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 reciban al menos una dosis de boceprevir se les ofrecerá la oportunidad de ser incluídos en el estudio de 3 años de seguimiento a largo plazo (P05063) tras completar su participación en este estudio. Los pacientes del brazo control con ARN-VHC detectable en la ST 12 podrán participar en un estudio de acceso expandido (P05514) y recibir boceprevir + PEG 1.5 mcg/kg/week + RBV durante 44 semanas como máximo.
    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 Decision2008-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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