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    Summary
    EudraCT Number:2012-003533-41
    Sponsor's Protocol Code Number:1241.20
    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:2012-09-26
    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 number2012-003533-41
    A.3Full title of the trial
    A Phase III, Randomised, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination with Faldaprevir and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 HCV Infection
    Ensayo clínico de fase III, aleatorizado, parcialmente doble ciego y controlado con placebo de BI 207127 en combinación con Faldaprevir y Ribavirina en pacientes con Hepatitis C crónica de genotipo 1 que no han recibido tratamiento previo (naïve)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial for testing efficacy and safety of BI 207127 in combination with Faldaprevir and Ribavirin in patients with Chronic Genotype 1 HCV Infection who received no previous medication
    Ensayo clínico para estudiar la eficacia y seguridad de BI 207127 en combinación con Faldeprevir y Ribavirina en pacientes con Hepatitis C crónica de genotivo 1 que no han recibido medicación previa
    A.4.1Sponsor's protocol code number1241.20
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of 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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBI 207127 NA / 200mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number -
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameFaldaprevir / 120mg
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfaldaprevir
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP 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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products 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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNribavirin
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    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
    Chronic infection with HCV - genotype 1
    Infección cróngica con VHC genotipo 1
    E.1.1.1Medical condition in easily understood language
    Chronic infection with Hepatitis C virus
    Infección crónica por el virus de la hepatitis C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim of the trial is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir (previously called BI 201335) and RBV for 16 and 24 weeks in target chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis. This ?target? population excludes GT1a infected patients with the host IL28B rs12979860 CT or TT (non-CC) genotypes.

    Primary objective of the trial is to determine if there is a clinically meaningful difference between 16- and 24-week treatment durations.
    El objetivo del estudio es confirmar la eficacia y seguridad del tratamiento con 600 mg BID de BI 207127 en combinación con 120 mg QD de Faldaprevir (nombre anterior BI 201335) y RBV durante 16 y 24 semanas en pacientes diana con infección crónica por HCV genotipo 1 (GT1) sin tratamiento previo, incluidos pacientes con cirrosis compensada. Quedan excluidos de esta población ?diana? los pacientes GT1a infectados con los genotipos IL28B rs12979860 CT o TT (no CC) del huésped.
    El objetivo principal es determinar si existe alguna diferencia clínicamente significativa entre el tratamiento mantenido durante 16 y 24 semanas.
    E.2.2Secondary objectives of the trial
    To determine if a minimum historical target SVR12 rate of 71% can be achieved by the combination treatments of BI 207127, Faldaprevir and RBV, including patients with compensated cirrhosis.
    El objetivo secundario es determinar si los tratamientos combinados de BI 207127, Faldaprevir y RBV pueden obtener una tasa mínima histórica de SVR12 del 71%, incluidos pacientes con cirrosis compensada
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    pharmacokinetic (PK) substudy, 45 patients, 3 PK days with 5 blood draws per days
    Subestudio de farmacocinética (PD), 45 pacientes, 3 días PK con 5 extracciones de sangre por día.
    E.3Principal inclusion criteria
    1. Chronic hepatitis C infection diagnosed by by positive anti-HCV antibodies and detected HCV RNA at screening in addition to at least one of the following:
    a. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening, OR
    b. liver biopsy indicating chronic HCV infection, OR
    c. history of elevated alanine aminotransferase (ALT) levels at least 6 months prior to screening.
    2. HCV infection of sub-GT1b confirmed by genotypic testing at screening, or HCV infection of sub-GT1a, GT1 with undefined subtype or 1a/1b subtype confirmed by genotypic testing at screening in patients with IL-28b CC genotype.
    3. Treatment naïve defined as:
    a. no prior treatment with any interferon, pegylated interferon, and /or ribavirin
    AND
    b. no prior treatment with at least one dose of any other licensed or investigational antiviral agent of for acute or chronic hepatitis C infection
    4. Plasma HCV RNA >= 1,000 IU/mL at screening
    5. Liver biopsy within three years or fibroscan within 6 months prior to randomisation. Note: patients with a liver biopsy performed 3 or more years or fibroscan performed 6 months or more prior to randomisation demonstrating cirrhosis do not need to repeat a liver biopsy or fibroscan. Patients with a liver biopsy performed 3 or more years (or fibroscan performed 6 months or more) prior to randomisation, negative for the presence of cirrhosis need to repeat the liver biopsy or fibroscan, with the result available before randomisation visit.
    6. Age 18 - 75 years (inclusive)
    7. Female patients
    a. with documented hysterectomy, OR
    b. who have had both ovaries removed, OR
    c. with documented tubal ligation, OR
    d. who are post-menopausal with last menstrual period at least 12 months prior to screening, OR
    e. of childbearing potential with a negative pregnancy test at screening and on Day 1 (Visit 2), that agree to use two non-hormonal methods of birth control from the date of screening until 7 months after the last dose of ribavirin. They must not breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Accepted methods of contraception for females in this trial are diaphragm with spermicide substances, intrauterine devices, cervical caps and condoms. Note: Systemic hormonal contraceptives may not be as effective in women taking BI 207127/FDV combination therapy and are not accepted methods of contraception in the study.
    OR
    Male patients
    a.who are documented to be sterile, OR
    b. who consistently and correctly use a condom while their female partners (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin, AND
    c. without pregnant female partners. It is in the responsibility of the male patient to ensure that his partner (or partners) is not pregnant prior to enrolment into the study or becomes pregnant during the treatment and follow-up phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
    8. Signed informed consent form prior to trial participation
    1. Infección crónica por hepatitis C, diagnosticada por la presencia de anticuerpos anti-HCV positivos y RNA del HCV detectado en la selección, adicionalmente a como mínimo uno de los siguientes criterios:
    a. anticuerpos anti-HCV positivos o RNA del HCV detectado como mínimo 6 meses antes del periodo de selección, O
    b. biopsia hepática característica de hepatitis C crónica, O
    c. antecedentes de niveles elevados de alanina aminotransferasa (ALT) al menos 6 meses antes del periodo de selección.


    2. Infección por HCV sub-GT1b confirmada mediante pruebas de genotipado durante la selección o infección por HCV sub-GT1a, GT1 con subtipo indefinido o subtipo 1a/1b confirmada mediante pruebas de genotipado durante la selección en pacientes con el genotipo IL-28b CC.
    3. Pacientes 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 aprobado o en fase de investigación para la infección aguda o crónica por el virus de la hepatitisC
    4. RNA del HCV plasmático ? 1.000 UI/ml en la selección
    5. Biopsia hepática no anterior a tres años o fibroscan en los seis meses previos a la aleatorización.

    Nota: aquellos pacientes con una biopsia hepática realizada 3 o más años antes de la selección o con un fibroscan hecho 6 o más meses antes de la selección que demostrase una cirrosis no tendrán que repetir una biopsia hepática o un fibroscan. Los pacientes con una biopsia hepática realizada más de 3 años antes del periodo de aleatorización (o con un fibroscan hecho más de 6 meses antes) y que no mostrase una cirrosis tendrán que repetir la biopsia hepática o el fibroscan y el resultado deberá estar disponible antes de la visita de aleatorización.
    6. Edad comprendida entre los 18 ? 75 años (inclusive)
    7. Mujeres
    a. con histerectomía comprobada, o
    b. con extirpación de ambos ovarios, o
    c. con ligadura de trompas comprobada, o
    d. posmenopáusicas, con el último periodo menstrual al menos 12 meses antes de la selección, o
    e. con posibilidad de quedar embarazadas, con prueba de embarazo en suero negativa en la selección y el día 1 (visita 2), que acepten usar dos métodos anticonceptivos no hormonales desde la fecha de selección hasta 7 meses después de la última dosis de ribavirina. Las mujeres deben aceptar no 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 aceptados para mujeres en este estudio son el diafragma con sustancia espermicida, capuchón cervical, dispositivos intrauterinos y preservativos.

    Nota: Es posible que los anticonceptivos hormonales no sean tan eficaces en las mujeres mientras toman la combinación BI 207127/FDV y no se aceptan como métodos anticonceptivos en este estudio.
    O:
    Hombres
    a. que se haya comprobado que son estériles, o
    b. que usen de forman constante y correcta un preservativo mientras que sus parejas femeninas (con posibilidad de quedar embarazadas) acepten usar uno de los métodos anticonceptivos médicamente aceptados desde la fecha de selección hasta 7 meses después de la última dosis de ribavirina, y
    c. sin parejas embarazadas. 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 con posibilidad de quedar embarazadas 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. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing
    at screening
    2. HCV subtype 1a, GT1 undefined or 1a/1b in patients with IL28b non-CC
    polymorphism
    3. Evidence of liver disease mainly due to causes other than chronic HCV infection
    such as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or
    Wilson?s disease.
    Note: patients with steatosis as part of the histologic findings on liver biopsy are not
    excluded.
    4. HIV-1 or HIV-2 infection
    5. Hepatitis B virus (HBV) infection based on presence of HBs-Ag
    6. Evidence of decompensated liver disease, or history of decompensated liver disease,
    defined as history of ascites, hepatic encephalopathy, bleeding esophageal varices or
    any other evidence of previous decompensation
    7. International Normalized Ratio (INR) of ?1.7
    8. Serum albumin ?3.5 g/dL
    9. Serum total bilirubin >2.0 times the upper limit of normal (ULN), unless history of
    Gilbert?s disease
    10. Active or suspected malignancy or history of malignancy within the last 5 years
    (with the exception of appropriately treated basal cell carcinoma of the skin or in situ
    carcinoma of the uterine cervix)
    11. Patients with ongoing or historical photosensitivity or recurrent rash
    12. Alcohol or drug abuse (except cannabis) within the past 12 months
    13. Body mass index <18 or > 35 kg/m2
    14. Usage of any investigational drugs within 28 days prior to randomisation, or the
    planned usage of an investigational drug during the course of the current study
    15. Known hypersensitivity to any ingredient of the study drugs
    16. A condition that is insufficiently diagnosed, treated or clinically unstable which in
    the opinion of investigator may put the patient at risk because of participation in this
    study, influence the results of this study, or limit the patient?s ability to participate in
    this study
    17. Alpha fetoprotein value >100ng/mL at screening; if > 20ng/mL and ? 100ng/mL,
    patients can be included if there is no evidence of liver cancer in an appropriate
    imaging study within 6 months prior to randomisation
    18. A history of severe pre-existing cardiac disease, including unstable or uncontrolled
    cardiac disease (e.g. congestive heart failure, myocardial infarction, unstable angina
    and arrhythmic disorders) current or within the previous 12 months before
    randomisation
    19. Received concomitant hematopoietic growth factor, or immunomodulatory treatment
    within 28 days prior to randomisation
    20. Received silymarin (milk thistle), glycyrrhizin, Sho-saiko-to (SST) or any
    medication listed in a restricted medication list provided in ISF within 28 days prior
    to randomisation, with the exception of parenteral analgesics used during liver biopsy
    procedure.
    The following exclusion criteria are potential contraindications for the use of PegIFN
    +/- RBV (for rationale please cf. Section 3.2)
    21. Pre-existing psychiatric conditions including but not limited to severe depression or
    hospitalization for depression, suicidal ideation and attempted suicide, schizophrenia,
    bipolar illness, severe anxiety or personality disorder, a period of disability or
    impairment due to a psychiatric disease current or within the previous 3 years before
    randomisation
    22. Abnormal thyroid function that cannot be controlled effectively by medication
    23. Active autoimmune-mediated disease known to be exacerbated by peginterferon
    therapy (e.g., Crohn?s disease, ulcerative colitis, idiopathic thrombocytopenic
    purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma,
    severe psoriasis)
    24. Requirement for chronic systemic corticosteroids (nasal or pulmonary steroids will
    be allowed)
    25. History or other evidence of severe retinopathy or clinically significant
    ophthalmological disorder due to diabetes mellitus or hypertension (but not limited to
    these conditions). For subjects with a history of hypertension or diabetes, written
    clearance from an ophthalmologist has to be obtained before the start of treatment
    26. Hemoglobin <11.0g/dL for women and <12.0g/dL for men
    27. Absolute neutrophil count < 1,500 cells/mm3
    28. Platelet count < 90,000 /mm3
    29. Creatinine clearance ?50 ml/min
    30. Diabetes mellitus with HbA1c > 8.5%
    31. Clinically evident red blood cell disorders which include but are not limited to
    thalassemia major, sickle cell anemia or glucose-6-phosphate dehydrogenase
    deficiency or glucose-6-phosphate dehydrogenase deficiency
    E.5 End points
    E.5.1Primary end point(s)
    Sustained Virologic Response at Week 12 after end of active* treatment (SVR12): Plasma HCV RNA level <25 IU/mL at 12 weeks after end of active* treatment.

    *As patients included in Group 1 and respectively Groups 2 and 3 have different durations of
    active treatment, SVR 4, 12 and 24 will be assessed at different timepoints, taken into
    consideration the time after end of active treatment
    Respuesta virológica mantenida en la semana 12 (SVR12): Nivel de RNA del HCV en plasma <25 UI/ml a las 12 semanas de finalizar el tratamiento.

    * Dado que la duración del tratamiento activo de los pacientes incluidos en el grupo 1, grupo 2 y grupo 3, respectivamente, es diferente, SVR 4, 12 y 24 se evaluará en distintos puntos temporales, teniendo en cuenta el tiempo después del final del tratamiento activo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after end of active treatment, meaning Week 28 for Group 1 (16 weeks of active therapy), and Week 36 for Groups 2 and 3 (24 weeks of active therapy), respectively
    12 semanas tras la finalización del tratamiento activo, es decir en la semana 28 para el grupo 1 (16 semas de tratamiento activo), y semana 36 para los grupos 2 y 3 (24 semanas de tratamiento activo), respectivamente
    E.5.2Secondary end point(s)
    - SVR4: Plasma HCV RNA level <25 IU/mL at 4 weeks after end of active* treatment.
    - SVR24: Plasma HCV RNA level <25 IU/mL at 24 weeks after end of active*
    treatment.

    *As patients included in Group 1 and respectively Groups 2 and 3 have different durations of
    active treatment, SVR 4, 12 and 24 will be assessed at different timepoints, taken into
    consideration the time after end of active treatment
    ??SVR4: Nivel plasmático de RNA del HCV <25 UI/ml 4 semanas después del final del tratamiento activo*.
    - SVR24: Nivel plasmático de RNA del HCV <25 UI/ml 24 semanas después del final del tratamiento activo*.

    * Dado que la duración del tratamiento activo de los pacientes incluidos en el grupo 1, grupo 2 y grupo 3, respectivamente, es diferente, SVR 4, 12 y 24 se evaluará en distintos puntos temporales, teniendo en cuenta el tiempo después del final del tratamiento activo
    E.5.2.1Timepoint(s) of evaluation of this end point
    SVR 4: 4 weeks after end of active treatment, meaning Week 20 for Group 1 (16 weeks of active therapy), and Week 28 for Groups 2 and 3 (24 weeks of active therapy),respectively.
    SVR 24: 24 weeks after end of active treatment, meaning Week 40 for Group 1 (16 weeks of active therapy), and Week 48 for Groups 2 and 3 (24 weeks of active therapy), respectively
    - SVR 4 : 4 semanas tras la finalización del tratamiento activo, es decir, en la semana 20 para el grupo 1 (16 semanas de tratamiento activo), y en la semana 28 para los gurpos 2 y 3 (24 semanas de tratamiento activo), respectivamente.

    - SVR 24: 24 semanas tras la finalización del tratamiento activo, es decir, en la semana 40 para el grupo 1 (16 semanas de tratamiento activo) y en la semana 48 para los grupos 2 y 3 (24 semanas de tratamiento activo), respectivamente.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 Yes
    E.8.1.7.1Other trial design description
    groups 1 and 2: double blind, placebo-controlled, group 3: open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Austria
    Brazil
    Canada
    France
    Germany
    Hungary
    Ireland
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Portugal
    Romania
    Russian Federation
    Spain
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS: 25 August 2015
    LVLS: 25 de agosto de 2015
    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 months9
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 540
    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)
    No planned treatment or care after trial participation end.
    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 Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-22
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