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    Summary
    EudraCT Number:2013-002169-21
    Sponsor's Protocol Code Number:5172-047
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-18
    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 number2013-002169-21
    A.3Full title of the trial
    A Phase II Clinical Trial to evaluate the Efficacy and Safety of a combination regimen of MK 5172 with/without MK 8742 and/or Ribavirin (RBV) in Subjects with Chronic Hepatitis C Genotypes 2, 4, 5 and 6 Infection
    Ensayo clínico de fase II para evaluar la eficacia y la seguridad de la combinación de MK 5172 con/sin MK 8742 y/o ribavirina (RBV) en sujetos con infección crónica por el virus de la hepatitis C de genotipo 2,4,5 y 6
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial testing the combination of MK-5172 and MK-8742 with Ribavirin in people with Hepatitis C
    Ensayo clínico para evaluar la combinación de MK 5172 y MK 8742 con ribavirina (RBV) en sujetos con hepatitis C
    A.3.2Name or abbreviated title of the trial where available
    MK-5172 + MK-8742 + Ribavirin in Genotype 2 HCV Patients
    MK-5172 + MK-8742 + Ribavirina en pacientes con HCV de genotipo 2
    A.4.1Sponsor's protocol code number5172-047
    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 SponsorMerck Sharp & Dohme Corp.
    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 supportMerck Sharp & Dohme Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, PO Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908740-5815
    B.5.5Fax number+1908740-3007
    B.5.6E-mailcyrus.badshah@merck.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.3.2Product code MK-5172
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMK-5172
    D.3.9.3Other descriptive nameMK-5172
    D.3.9.4EV Substance CodeSUB30825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.3.2Product code MK-8742
    D.3.4Pharmaceutical form Capsule
    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 INNMK-8742
    D.3.9.3Other descriptive nameMK-8742
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Rebetol
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, Sharp & Dohme
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Virus Genotype 2
    Virus Hepatitis C Genotipo 2
    E.1.1.1Medical condition in easily understood language
    Hepatitis C Virus Infection
    Infección 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10047457
    E.1.2Term Viral 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
    In treatment naïve (TN) non-cirrhotic subjects with chronic HCV infection with GT2, 4, 5 or 6:
    (1)Objective: To evaluate the efficacy of MK-5172 in combination with or without MK-8742 and/or RBV for 12 weeks as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA <25 IU/mL (either TD(u) or TND) 12 weeks after the end of all study therapy.
    (2)Objective: To evaluate the safety and tolerability of each treatment arm of MK-5172 in combination with or without MK-8742 and/or RBV.
    En sujetos con infección crónica por el VHC STP no cirróticos con GT2,4,5 o 6.
    (1)Objetivo: Evaluar la eficacia de MK 5172 en combinación con o sin MK 8742 y/o RBV durante 12 semanas determinada mediante la proporción de sujetos que logren una RVS12 (respuesta virológica sostenida 12 semanas después del final del tratamiento del estudio), definida como una concentración de ARN del VHC < 25 UI/ml (objetivo detectable no cuantificable [OD(nc)] u objetivo no detectable [OND]) 12 semanas después del final de todo el tratamiento del estudio.
    (2)Objetivo: Evaluar la seguridad y la tolerabilidad de MK 5172 en combinación con o sin MK 8742 y/o RBV
    E.2.2Secondary objectives of the trial
    In treatment naïve (TN) subjects with chronic GT2, GT4, GT5 and GT6 HCV infection:
    (1) Objective: To evaluate the efficacy in each treatment arm of MK-5172 with/without MK-8742 and/or RBV as assessed by the time to achieve undetectable (target not detectable, TND) HCV RNA levels.
    (2) Objective: To evaluate the efficacy in each treatment arm of MK-5172 in combination with/without MK-8742 and/or RBV as assessed by the proportion of subjects achieving undetectable (TND) HCV RNA levels and HCV RNA levels <25 IU/mL [target detectable, unquantifiable, TD(u)] at Week 2, Week 4, and end of treatment visit (Week 12).
    (3) Objective: To evaluate the efficacy in each treatment arm of MK-5172 in combination with/without MK-8742 and/or RBV as assessed by the proportion of subjects achieving (Con. Read in the protocol)
    En sujetos con infección crónica por el VHC de GT2, GT4, GT5 y GT6, STP:
    (1)Evaluar la eficacia en cada grupo de tratamiento de MK 5172 con/sin MK 8742 y/o RBV, determinada mediante el tiempo en lograr una concentración indetectable de ARN del VHC (OND).
    (2) Evaluar la eficacia de MK 5172 en cada grupo de tratamiento con/sin MK 8742 y/o RBV, determinada mediante la proporción de sujetos que logren una concentración indetectable (OND) de ARN del VHC y una concentración de ARN del VHC < 25 UI/ml (OD(nc)) en la semana 2, la semana 4 y la visita de final del tratamiento (semana 12).
    (3) Evaluar la eficacia de MK 5172 en cada grupo de tratamiento con/sin MK 8742 y/o RBV, determinada mediante la proporción de sujetos que logren (Continuar leyendo en el protocolo).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Be > or = to 18 years of age on day of signing informed consent.
    2.Have a body weight > or = to 50 kg (111 lbs) and < or = to 125 kg (275 lbs).
    3.For Part B only: have chronic HCV GT2, or GT4, or GT5 or GT6 infection
    -Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA (> or = to 10,000 IU/mL in peripheral blood) at the time of screening
    -Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy or other signs or symptoms of advanced liver disease or cirrhosis
    4.Have absence of cirrhosis, which is defined as any one of the following:
    -Liver biopsy performed within 2 years of Day 1 of this study showing absence of cirrhosis
    -Fibroscan (in countries where locally approved) performed within 12 months of Day 1 of this study with a result of < or = to 12.5 kPa
    -A FibroTest (FibroSure®) score of < or = to 0.48 and aspartate aminotransferase (AST) platelet ratio index (APRI) of < or = to1 during Screening
    5.Agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential).
    6.Understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    7.Provide written informed consent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
    1.Tener una edad mínima de 18 años el día de la firma del consentimiento informado.
    2.Tener un peso corporal mayor o igual a 50 y menor o igual a 125 kg.
    3.Tener infección crónica por el VHC de GT2.
    -Positividad para anticuerpos anti VHC, ARN del VHC o un genotipo del VHC 6 meses antes de la selección, como mínimo, y positividad para ARN del VHC (> o = a 10.000 UI/ml en sangre periférica) en el momento de selección.
    -Ausencia (sin antecedentes médicos ni hallazgos físicos) de ascitis, varices esofágicas hemorrágicas, encefalopatía hepática u otros signos o síntomas de hepatopatía avanzada o cirrosis.
    4.No presentar cirrosis, definida como el cumplimiento de cualquiera de los criterios siguientes:
    -Biopsia hepática practicada en los 2 años previos al día 1 del estudio que revela ausencia de cirrosis.
    -FibroScan (en países en los que esté aprobado) realizado en los 12 meses previos al día 1 del estudio con un resultado de < o = a 12,5 kPa [30].
    -Puntuación FibroTest (FibroSure®) < o = a 0,48 e índice de aspartato aminotransferasa (AST)/plaquetas (IAP) < o = a 1 durante la selección.
    5.Comprometerse a utilizar dos métodos anticonceptivos aceptables desde al menos 2 semanas antes del día 1 y seguir utilizándolos hasta al menos 6 meses después de la última dosis del fármaco del estudio o durante más tiempo si así lo dictan las normativas locales (para las mujeres en edad fértil y los varones con parejas en edad fértil).
    6.Comprender los procedimientos del estudio, los tratamientos alternativos disponibles y los riesgos asociados y aceptar voluntariamente participar otorgando el consentimiento informado por escrito.
    7.Otorgar su consentimiento informado para el ensayo. El sujeto también podrá otorgar su consentimiento/asentimiento para la investigación biomédica futura. No obstante, podrá participar en el ensayo principal sin necesidad de hacerlo en la investigación biomédica futura.
    E.4Principal exclusion criteria
    1.Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures
    2.For Part B: has HCV infection with a genotype other than GT2, GT4, GT5 or GT6, including a mixed GT infection or a non-typeable genotype.
    3.Is NOT treatment naïve, i.e. subject has had previous treatment with any interferon, RBV, approved or experimental direct-acting antiviral(s), or other investigational therapies for HCV.
    4.Is coinfected with hepatitis B virus (HBsAg positive) or HIV.
    5.Has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
    6.Is taking or plans to take any of the prohibited medications listed in Section 5.5 of this protocol within 2 weeks prior to day 1.
    7.Is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject?s medical care).
    8.Has a clinical diagnosis of substance abuse
    9.Has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ, squamous cell carcinoma, and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
    10.(female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criterion Nº 5); or male subject is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criterion Nº 5).
    11.Is a male whose female partner(s) is pregnant (this is a contraindication for RBV use).
    12.Has any other condition which, in the opinion of the principal investigator or study physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study , including but not limited to:
    -Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
    -Hemoglobinopathy, including, but not limited to, thalassemia major
    -Poor venous access that precludes routine peripheral blood sampling required for this trial.
    -Subject with indwelling venous catheters.
    -Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
    -Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
    13.Had a life-threatening SAE during the screening period.
    14.Is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
    15.Has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
    NOTE: Subjects with history of acute non-HCV-related hepatitis, which resolved > 6 months before study entry, can be enrolled.
    16.For subjects diagnosed with diabetes mellitus, documented HbA1c >8.5% (to exclude uncontrolled diabetes).
    17.Has exclusionary laboratory values as listed below (see Section 12.5 for unit conversions of some laboratory values specified in the Protocol)
    1.No tengan la edad de consentimiento legal, estén incapacitados mental o legalmente, tengan problemas emocionales importantes en el momento de la visita de selección previa al estudio o puedan tenerlos previsiblemente durante la realización del estudio o tengan antecedentes de un trastorno psiquiátrico clínicamente importante que, en opinión del investigador, podría interferir en los procedimientos del estudio.
    2.No tengan infección por el VHC de GT2, GT4, GT5 o GT 6, incluida una infección por genotipos mixtos o por un genotipo no tipificable.
    3.NO sean STP, es decir, el sujeto ha recibido tratamiento previo con cualquier interferón, RBV, antivirales de acción directa aprobados o experimentales u otros tratamientos en investigación para el VHC.
    4.Presenten coinfección por el virus de la hepatitis B (positividad para el AgHBs) o el VIH.
    5.Presenten indicios de carcinoma hepatocelular (CHC) o se encuentren en evaluación por un posible CHC.
    6.Estén tomando o tengan previsto tomar alguno de los medicamentos prohibidos que se indican en la sección 5.5 de este protocolo en las dos semanas previas al día 1.
    7.Estén participando o hayan participado en un estudio sobre un compuesto experimental en los 30 días previos a la firma del consentimiento informado y no estén dispuestos a abstenerse de participar en otro estudio. Queda prohibida la obtención de muestras adicionales de sangre, orina o tejidos o de otros datos aparte de lo especificado en este protocolo (a excepción de la relacionada con la atención médica del sujeto).
    8.Tengan un diagnóstico clínico de abuso de las sustancias.
    9.Tengan datos de una neoplasia maligna activa o presunta o antecedentes de una neoplasia maligna en los cinco años anteriores (a excepción de carcinoma in situ, carcinoma espinocelular y carcinoma basocelular de piel debidamente tratados). No podrán participar los sujetos sometidos a evaluación para descartar neoplasias malignas.
    10.(mujeres) Estén embarazadas o en período de lactancia, tengan intención de concebir o donar óvulos o estén en edad fértil y no se muestren dispuestas a utilizar dos métodos anticonceptivos durante el tratamiento y tras su finalización (véase el criterio de inclusión n.º 5) o bien (varones) tengan intención de fecundar o donar semen o tengan una pareja en edad fértil y no se muestren dispuesto a utilizar dos métodos anticonceptivos durante el tratamiento y tras su finalización (véase el criterio de inclusión n.º 5).
    11.Sean varones cuya pareja esté embarazada (contraindicación del uso de RBV).
    12.Presenten cualquier otra situación que, en opinión del investigador principal o del médico del estudio, podría hacer que no fueran aptos para el estudio o que podría interferir en su participación y finalización del estudio, entre otras las siguientes:
    -Trasplantes de órganos (incluidos los trasplantes de células madre hematopoyéticas), salvo los de córnea y cabello.
    -Hemoglobinopatía, como talasemia mayor, entre otras.
    -Dificultad de acceso venoso que impida la extracción habitual de sangre periférica exigida para los fines de este ensayo.
    -Presencia de catéteres venosos permanentes.
    -Antecedentes de cirugía gástrica (por ejemplo, reducción del estómago con grapas o derivación) o de trastornos de malabsorción (por ejemplo, enfermedad celíaca).
    -Cualquier enfermedad que necesite o vaya a necesitar probablemente la administración sistémica crónica de corticosteroides durante el transcurso del ensayo.
    13.Presenten un acontecimiento adverso grave (AAG) potencialmente mortal durante el período de selección.
    14.Sean miembros o parientes de un miembro del equipo de investigación o del personal del promotor directamente relacionado con este estudio.
    15.Tengan datos o antecedentes de hepatitis crónica no causada por el VHC, como esteatohepatitis no alcohólica (EHNH), hepatitis medicamentosa y hepatitis autoinmunitaria.
    NOTA: Podrán participar los sujetos con antecedentes de hepatitis aguda no relacionada con el VHC que se haya resuelto más de seis meses antes de la incorporación al estudio.
    16.En los sujetos diagnosticados de diabetes mellitus, HbA1c > 8,5% documentada para excluir a diabéticos mal controlados.
    17.Presenten valores analíticos que sean motivo de exclusión, tal como se indica a continuación (véanse en la sección 12.5 las conversiones de unidades de algunos valores analíticos especificados en el Protocolo).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the proportion of subjects achieving SVR12 in each of the treatment arms.
    La variable principal de eficacia será la proporción de sujetos que logran la RVS 12 en cada grupo de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 Weeks after the end of all study therapy
    12 semanas después de todo el tratamiento del estudio.
    E.5.2Secondary end point(s)
    Secondary evaluations of efficacy are based on SVR4 (Sustained Virologic Response 4 weeks after the end of all study therapy), HCV RNA measurements at Week 2, Week 4, and end of treatment visit (Week 12).
    Las variables secundarias de eficacia se basan en la RVS4 (Respuesta viral sostenida 4 semanas despues del final del tratamiento del estudio), el valor del RNA del VHC en la semana 2, semana 4 y en la visita de final de tratamiento (Semana 12).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 2, Week 4, end of treatment visit (Week 12) and Follow Up 4.
    Semana 2, semana 4 ,visita de final de tratamiento (Semana 12) y Seguimiento 4.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Australia
    Belgium
    Italy
    Spain
    Israel
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.2.1Number of subjects for this age range: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 70
    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)
    If subject is cured, no further treatment is needed. If not cured, he can be treated by standard of care which is outside the scope of the protocol. Sponsor will not provide that medication as it is standard of care. The subject will be followed in another protocol within the compound program for 3 years.
    Si un paciente se cura, no necesitará más tratamiento. Si no se cura, puede ser tratado con el tratamiento de referencia, fuera del ámbito del protocolo. El promotor no proporcionará esta medicación ya que es el tratamiento de referencia. El sujeto será seguido durante 3 años en otro protocolo del programa del compuesto.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-04
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