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    Summary
    EudraCT Number:2009-018197-66
    Sponsor's Protocol Code Number:1241.21
    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:2010-03-29
    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 number2009-018197-66
    A.3Full title of the trial
    Ensayo clínico de seguridad, efecto antiviral y farmacocinética de BI 207127 en combinación con BI 201335 y con Ribavirina durante 4 semanas (Parte 1) y con o sin ribavirina durante 24-48 semanas (Parte 2) en pacientes con Hepatitis C crónica de genotipo 1 (aleatorizado, abierto, de fase II)

    Safety, antiviral effect and pharmacokinetics of BI 207127 in combination with BI 201335 and with ribavirin for 4 (Part 1) and with or without ribavirin for 24-48 weeks (Part 2) in patients with chronic HCV genotype 1 infection (randomized, open label, Phase II)
    A.4.1Sponsor's protocol code number1241.21
    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 SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 nameBI 201335 NA / 120mg
    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.3.9.2Current sponsor codeBI 201335 NA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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 nameBI 207127 NA / 200mg
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeBI 207127 NA
    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: 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 Copegus 200mg (Ribavirin)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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.3.9.1CAS number 36791-04-5
    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: 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 Pegasys (pegylated interferon-? 2a)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Solution for 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 2A
    D.3.9.1CAS number 198153-51-4
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatitis C crónica de genotipo 1

    chronic hepatitis C infection of genotype 1
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Parte 1: Seguridad, efecto antiviral y evaluación de cualquier interacción farmacocinética (PK) de BI 207127 en combinación con BI 201335 y ribavirina durante 4 semanas en pacientes con infección crónica por Hepatitis C de genotipo 1 que no hayan recibido previamente tratamiento.


    Part 2: Seguridad y efecto antiviral de BI 207127 en combinación con BI 201335, con o sin ribavirina durante 24 o 48 semanas en pacientes con infección crónica por VHC de genotipo 1.
    E.2.2Secondary objectives of the trial
    N.a.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    El objetivo de esta prueba farmacogenética es investigar el efecto de las características genéticas sobre la forma en que el organismo procesa los medicamentos en personas con Hepatitis C.
    E.3Principal inclusion criteria
    1. Infección crónica por hepatitis C, diagnosticada por la presencia de anticuerpos del VHC positivos o ARN del VHC detectable en sangre al menos 6 meses antes de la selección, o por biopsia hepática característica de hepatitis C crónica en combinación con serología de VHC positiva.
    2. Infección por el genotipo 1 (1a, 1b o mixto 1a/1b) de VHC confirmada mediante pruebas de genotipado en la selección.
    3. Sin tratamiento previo, definido como:
    (a) ningún tratamiento previo con ningún interferón, interferón pegilado ni ribavirina.
    y
    (b) ningún tratamiento previo con al menos una dosis de cualquier antiviral directo por infección aguda o crónica por hepatitis C.
    4. Carga viral del VHC ? 100.000 UI/ml en la selección.
    5. Biopsia hepática en los dos años anteriores o Fibroscan en los seis meses previos a la selección que excluya la cirrosis.
    6. Edad 18-75 años.
    7. Mujeres
    (a) con histerectomía comprobada, o
    (b) con extirpación de ambos ovarios, o
    (c) con ligadura de trompas comprobada, o
    (d) post-menopáusicas, con el último periodo menstrual al menos 12 meses antes de la selección, o
    (e) en edad fértil, con prueba de embarazo en suero negativa en la selección y el día 1 (visita 2), que acepten abstenerse de mantener relaciones sexuales o acepten usar uno de los métodos anticonceptivos médicamente adecuados desde la fecha de selección hasta 7 meses después de la última dosis de ribavirina además del uso constante y correcto de un preservativo. No deben amamantar a su hijo en ningún momento desde la selección y hasta 7 meses después de la última dosis de ribavirina.
    Los métodos de anticoncepción médicamente aceptados para mujeres en este estudio son los anticonceptivos que contengan etinilestradiol, diafragma con sustancia espermicida y capuchón cervical.
    O
    Hombres
    (a) que se haya comprobado que son estériles, o
    (b) que acepten abstenerse de mantener relaciones sexuales desde la fecha de selección hasta 7 meses después de la última dosis de ribavirina, o
    (c) que usen de forman constante y correcta un preservativo mientras que su pareja femenina (si están en edad fértil) acepte usar uno de los métodos anticonceptivos médicamente aceptados desde la fecha de selección hasta 7 meses después de la última dosis de ribavirina, y
    (d) sin pareja embarazada. Es responsabilidad del paciente varón asegurarse de que su pareja (o parejas) no está embarazada antes de la inclusión en el estudio o de que no se quede embarazada durante la fase de tratamiento y de seguimiento. Las parejas femeninas en edad fértil deben realizarse mensualmente pruebas de embarazo desde la fecha de selección hasta 7 meses después de la última dosis de ribavirina (el promotor proporcionará las pruebas).
    8. Formulario de consentimiento firmado antes de participar en el estudio
    E.4Principal exclusion criteria
    1.Infección por hepatitis C de genotipo mixto (1/2, 1/3 y 1/4) diagnosticado por análisis del genotipo en la selección.
    2.Signos de hepatopatía por causas que no sean infección crónica por el VHC.
    3.Positivo en ELISA para VIH-1 o VIH-2.
    4.Infección por el virus de la hepatitis B (VHB) basado en la presencia de HBs-Ag.
    5.Enfermedad hepática descompensada o antecedentes de enfermedad hepática descompensada.
    6.Neoplasia activa o sospechada o antecedentes de neoplasia en los 5 últimos años (con la excepción de carcinoma cutáneo basocelular tratado adecuadamente o carcinoma de cuello uterino in situ).
    7.Pacientes con fotosensibilidad en curso o anterior o erupción cutánea recurrente.
    8.Antecedentes de abuso de alcohol o de fármacos (excepto cannabis) en los últimos 12 meses.
    9.Índice de masa corporal <18 o > 35 kg/m2.
    10.Uso de cualquier fármaco en fase de investigación en los 30 anteriores a la inclusión o 5 semividas, lo que sea más prolongado, o uso previsto de un fármaco en fase de investigación durante el transcurso del estudio actual.
    11.Hipersensibilidad comprobada a cualquier componente del fármaco del estudio.
    12.Un trastorno que se defina como uno que, en opinión del investigador, puede afectar a la participación de paciente en el ensayo o puede influir en los resultados delensayo o la capacidad del paciente para participar en el ensayo.
    13.Valor de alfa-fetoproteína >100 ng/ml en la selección; si es > 20 ng/ml y ? 100 ng/ml, los pacientes pueden incluirse si no hay signos de cáncer de hígado en un estudio de representación por imágenes adecuado (p. ej. ecografía, TAC, RMN) en los 6 meses anteriores a la aleatorización.
    14.Bilirrubina total > 1,5 x LSN con una proporción directa/indirecta > 1.
    15.AST o ALT > 5 x LSN.
    16.Tiempo de protrombina INR (Cociente internacional normalizado) prolongado a >1,5 x LSN.
    17.Necesidad de corticoesteroides sistémicos crónicos (se permitirán los corticoesteroides nasales o pulmonares)
    18.Recibir tratamiento antiviral sistémico concomitante, factor de crecimiento hematopoyético o tratamiento inmunomodulador en los 30 días previos a la inclusión o 5 semividas, lo que sea más prolongado; podrá incluirse a los pacientes en tratamiento con antivirales orales como aciclovir, famciclovir, valciclovir por infección recurrente localizada leve por herpes simple o con oseltamivir y zanamivir por gripe A.
    19.Recibir silimarina (cardo mariano) o glicirricina o Sho-saiko-to (SST) en los 30 días previos a la inclusión.
    20.Hemoglobina <12,0 g/dl para mujeres y <13,0 g/dl para hombres
    21.Recuento de leucocitos <2.000 células/mm3
    22.Recuento absoluto de neutrófilos ? 1.500/mm3
    23.Recuento de plaquetas < 100.000 /mm3
    24.Signos de enfermedad renal aguda o crónica (p. ej., creatinina sérica por encimadel límite de lo normal)
    25.Diabetes mellitus mal controlada demostrada por HbA1c > 7,5%
    26.TSH y T4 fuera de los límites normales (aceptado si se controla debidamente la función tiroidea).
    27.Signos clínicos de enfermedad pulmonar crónica.
    28.ECG en la selección con alteraciones que indiquen una enfermedad cardiovascular previa o activa.
    29.Signos clínicos de cardiopatía crónica (p. ej., enfermedad coronaria, insuficiencia cardiaca congestiva, hipertensión no controlada, arritmia significativa).
    30.Enfermedad autoinmune, como hepatitis autoinmune.
    31.Hemoglobinopatía (p. ej., talasemia mayor o anemia drepanocítica).
    32.Carencia de glucosa-6-fosfato-deshidrogenasa.
    33.Antecedentes de enfermedad psiquiátrica moderada, grave o sin controlar, especialmente depresión, como antecedentes de hospitalización o intento de suicido previo; los pacientes con antecedentes de depresión leve y estable podrán ser admitidos siempre que una evaluación previa al tratamiento de la enfermedad psiquiátrica del paciente confirme que el paciente está clínicamente estable (el investigador debe elaborar y registrar un plan de tratamiento de la depresión antes de la aleatorización de estos pacientes y revisar la enfermedad psiquiátrica del paciente según el plan en los planes de visita normalizados).
    34.Resultados anómalos en el examen del fondo del ojo que excluyan el tratamiento con IFN en los 6 meses previos a la aleatorización.
    35.Antecedentes de transplante de órgano, que no sea de córnea ni de cabello.
    36.Trastorno convulsivo activo en los 2 últimos años; podrá incluirse a los pacientes si están tomando medicación estable y no han sufrido convulsiones durante más de 2 años antes de la inclusión
    E.5 End points
    E.5.1Primary end point(s)
    Parte 1: Respuesta Virológica rápida (RVR): nivel plasmático del ARN del VHC < 25 UI/mL en la semana 4.

    Parte 2: Respuesta virológica mantenida (SVR): ARN del VHC plasmático< 25 UI/mL 24 semanas después de la finalización del tratamiento completo.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA 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
    last visit of the last patient undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 122
    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)
    Patients receive SOC treatment, in case of lack or loss of virological response during PegIFN-sparing investigational combination therapy (provided by BI). Patients failing treatment after end of investigational treatment or during PegIFN-based follow-up treatment may enter other clinical trials with direct acting antivirals, in case they rebound or do not respond (with the limitation that they may have acquired resistance to other HCV protease and polymerase inhibitors as well)
    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 Decision2010-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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