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    Summary
    EudraCT Number:2012-003984-23
    Sponsor's Protocol Code Number:BOC-HIV
    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:2013-02-04
    Trial 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 number2012-003984-23
    A.3Full title of the trial
    A phase III open label study to evaluate safety and efficacy of Boceprevir-response guided therapy in controlled HIV patients with chronic hepatitis C genotype 1 infection who failed previously to Peginterferon /ribavirin.
    Estudio abierto de fase III para evaluar la eficacia y la seguridad del tratamiento con boceprevir en pacientes coinfectados por el VIH y VHC (genotipo 1), que han fracasado al tratamiento previo con peginterferón y ribavirina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III open label study to evaluate safety and efficacy of Boceprevir-response guided therapy in controlled HIV patients with chronic hepatitis C genotype 1 infection who failed previously to Peginterferon /ribavirin.
    Estudio abierto de fase III para evaluar la eficacia y la seguridad del tratamiento con boceprevir en pacientes coinfectados por el VIH y VHC (genotipo 1), que han fracasado al tratamiento previo con peginterferón y ribavirina
    A.3.2Name or abbreviated title of the trial where available
    BOC-HIV
    BOC-HIV
    A.4.1Sponsor's protocol code numberBOC-HIV
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMSD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU clinic (Clinical Trial Unit). Farmacología Clínica. hospital clinic
    B.5.2Functional name of contact pointCTU Clinic
    B.5.3 Address:
    B.5.3.1Street Addressrosello 138
    B.5.3.2Town/ citybarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754009838
    B.5.5Fax number+3493227987700
    B.5.6E-mailmallolas@clinic.ub.es
    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 Yes
    D.2.1.1.1Trade name Victrelis 200 mg capsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Reino Unido
    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 nameVictrelis 200 mg cápsulas duras
    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 INNboceprevir
    D.3.9.3Other descriptive nameBOCEPREVIR
    D.3.9.4EV Substance CodeSUB31579
    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 Yes
    D.2.1.1.1Trade name Ribavirina Teva 200 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma B.V. Computerweg 10, 3542 DR Utrecht Holanda
    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 name200 mg de ribavirina
    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 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.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.2.5The 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 namepeginterferón alfa-2a
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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
    D.3.9.1CAS number 198153-51-4
    D.3.9.3Other descriptive namePEGINTERFERON
    D.3.9.4EV Substance CodeSUB25548
    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
    HCV and HIV seropositive coinfection
    Coinfección VHC y VIH
    E.1.1.1Medical condition in easily understood language
    HCV and HIV seropositive coinfection
    Coinfección VHC y VIH
    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 LLT
    E.1.2Classification code 10065949
    E.1.2Term HCV coinfection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed TID orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy .
    El objetivo principal de este estudio es evaluar la seguridad y la eficacia del tratamiento guiado por la respuesta con boceprevir 800 mg tres veces al día por vía oral (v.o.) en combinación con peginterferón (alfa-2b o alfa-2a) y ribavirina en pacientes infectados por el VIH y el VHC del genotipo 1 en los que había fracasado un tratamiento previo contra el VHC con interferón pegilado asociado a ribavirina.
    E.2.2Secondary objectives of the trial
    ? To define predictors of sustained virological response (SVR), such as epidemiologic factors, disease characteristics, HIV clinical condition and on-treatment response especially at week 4 (lead in); week 8, week 12 and week 24.
    ? The proportion of patients with undetectable HCV RNA at TW4, TW8, TW12 and at the end of treatment.
    ? Evaluate lead-in response regarding treatment history
    ? Resistance of HCV after virological failure of BOC containing regimens.
    ? Definir los factores predictivos de la respuesta virológica sostenida (RVS), como los factores epidemiológicos, las características de la enfermedad, la situación clínica de la infección por el VIH y la respuesta durante el tratamiento, especialmente en las semanas 4 , 8, 12 y al final del tratamiento.
    ? Determinar el porcentaje de pacientes con ARN del VHC indetectable en las semanas de tratamiento (ST) 4, 8 y 12 y al final del tratamiento.? Evaluar la respuesta virológica en función de las características basales ? Investigar la resistencia del VHC tras el fracaso virológico con un regímenque contiene boceprevir (BOC).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must meet ALL criteria listed below for entry
    1. For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.
    2. Subject must have previously documented CHC genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ?10,000 IU/mL.
    3. Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:
    a. No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
    b. Cirrhosis. No specific length of time would be requested.
    4. All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
    5. Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).
    6. Subject must be ?18 years of age.
    7. HIV treatment should not contain EFV, NVP, ETV, ddI, d4T, AZT, or HIV protease inhibitors.
    8. Subject must weight between 40 kg and 125 kg.
    9. Subject and subject?s partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug.
    10. Subjects must be willing to give written informed consent and by investigator opinion could follow the protocol visit design.
    1. Para participar en el estudio, los pacientes deben haber recibido tratamiento con peginterferón alfa-2a más ribavirina o con peginterferón alfa-2b más ribavirina durante un mínimo de 12 semanas. Si un paciente ha recibido más de una de estas pautas, se tendrá en cuenta la más reciente.
    2. El paciente debe tener una HCC causada por el virus del genotipo 1 (subtipo a o b) documentada previamente. Los pacientes con otros genotipos o con genotipos mixtos no podrán participar. El resultado de ARN del VHC en la visita de selección debe confirmar la infección por el virus de genotipo 1 y ser >10.000 UI/ml.
    3. El paciente debe tener una biopsia hepática con una histología compatible con HCC y ninguna otra etiología o una evaluación con Fibroscan. En caso de:
    a. Ausencia de cirrosis. Las biopsias o el Fibroscan deberán haberse hecho en los 18 meses anteriores a la visita de selección.
    b. Cirrosis No se requiere un plazo de tiempo concreto.
    4. Todos los pacientes con cirrosis deberán tener una ecografía efectuada en los 6 meses anteriores a la visita de selección.
    5. Los pacientes deben estar recibiendo un tratamiento antirretroviral estable con un recuento de linfocitos CD4 superior a 100/mm3 y una carga viral plasmática del VIH indetectable (< 50 copias/ml) durante más de 6 meses. El tratamiento antirretroviral debe contener raltegravir (al menos durante las últimas 6 semanas).
    6. El paciente debe ser mayor de 18 años.
    7. El tratamiento contra el VIH no debe contener EFV, NVP, ETV, ddI, d4T, AZT ni inhibidores de la proteasa del VIH.
    8. El paciente debe pesar entre 40 y 125 kg.
    9. El paciente y su pareja deben comprometerse a utilizar métodos anticonceptivos aceptables desde al menos 2 semanas antes del día 1 y hasta como mínimo 6 meses después de la última dosis del fármaco del estudio.(prueba de embarazo negativa en mujeres en edad fértil)
    (se define postmenopausia como ausencia de menstruación durante el año anterior a la entrada en el estudio).

    10.Los pacientes deben estar dispuestos a dar su consentimiento informado por escrito y, en opinión del investigador, ser capaces de seguir el diseño de las visitas del protocolo.
    E.4Principal exclusion criteria
    1. Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
    2. Patients chronically infected with HCV genotype other than 1
    3. CD4 cell count < 100 cel/mm3.
    4. Plasma HIV RNA more than 50 copies/mL
    5. Platelet count less than 80.000 /mm3
    6. Subjects who required discontinuation of previous interferon or ribavirin regimen for a severe adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
    7. Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
    8. Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
    9. Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
    10. History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
    11.. Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
    12. Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
    13. Unstable or untreated pre-existing psychiatric condition.
    14. Any known pre-existing medical condition that could interfere with the subject?s participation in and completion of the study.
    15. Any current evidence of substance abuse of alcohol or other drugs.
    16.Subjects receiving Opiod Agonist substitution therapy but not enrolled in an opiate substitution maintenance progam.
    1. Pacientes con coinfección por el virus de la hepatitis B (positividad para el AgHBs) confirmada.
    2. Pacientes con infección crónica por el VHC de genotipos distintos del 1
    3. Recuento de linfocitos CD4 <100 células/mm3.
    4. ARN del VIH en plasma superior a 50 copias/ml
    5. Recuento de plaquetas inferior a 80.000/mm3
    6. Pacientes en los que hubo que suspender el tratamiento previo con interferón o ribavirina por un acontecimiento adverso grave que el investigador consideró posible o probablemente relacionado con la ribavirina o el interferón.
    7. Tratamiento con ribavirina en los 90 días anteriores y con cualquier interferón alfa en el mes anterior a la visita de selección.
    8. Tratamiento contra la hepatitis C con cualquier producto en investigación. Los tratamientos previos con productos de fitoterapia con hepatotoxicidad conocida son motivo de exclusión.
    9. Participación en otro ensayo clínico en los 30 días anteriores a la aleatorización o intención de participar en otro ensayo clínico durante la participación en el presente estudio.
    10. Antecedentes de hemoglobinopatía (por ejemplo, talasemia) u otra causa de hemólisis, o la tendencia hemolítica.
    11. Signos de hepatopatía descompensada, como antecedentes o presencia de ascitis clínica, varices hemorrágicas o encefalopatía hepática.
    12. Pacientes diabéticos o hipertensos con signos de importancia clínica en la exploración oftalmológica.
    13. Enfermedad psiquiátrica preexistente inestable o sin tratar.
    14. Cualquier enfermedad médica preexistente conocida que pudiera interferir en la participación del paciente en el ensayo y en su finalización.
    15. Cualquier signo actual de alcoholismo o de consumo de otras drogas.
    16. Pacientes que reciben tratamiento sustitutivo con agonistas opiáceos pero no participan en ningún programa de mantenimiento con sustitución de opiáceos.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint: The primary efficacy endpoint is the achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCVRNA level at FW 12, the subject would be considered an SVR.

    Futility rules.

    HCV treatment failure is defined as follows:

    ? Serum HCV RNA ? 100 IU/mL at week 12
    OR
    ? Confirmed increase in serum HCV RNA to > 1,000 IU/mL at any time point after week 12
    OR
    ? Detectable (above the lower limit of detection of the Roche COBAS® Taqman ® HCV Test v2.0 assay) serum HCV RNA at week 24
    El criterio de valoración principal de la eficacia es la consecución de la RVS, definida como un ARN del VHC en plasma indetectable en la semana de seguimiento (SS) 24.
    Si en un paciente no se dispone de los datos de la SS24 y el ARN del VHC en la SS12 es indetectable, se considerará que presenta una RVM.

    Normas de futilidad:
    El fracaso del tratamiento contra el VHC se define de la manera siguiente:

    ? ARN del VHC en suero >100 UI/ml en la semana 12
    O
    ? Aumento confirmado del ARN del VHC en suero hasta >1.000 UI/ml en cualquier momento después de la semana 12
    O

    ? ARN del VHC detectable (por encima del límite inferior de detección del análisis del VHC COBAS® Taqman® v2,0. de Roche ) en la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    ? The proportion of subjects with virological response (eg. undetectable HCV-RNA at Weeks 2, 4, 8, or 12) in subjects who achieve SVR.
    ? The proportion of subjects with undetectable HCV-RNA at FW 12.
    ? The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
    ? Resistance of HCV after BOC containing regimen. Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).
    ? Safety
    ? Porcentaje de pacientes con respuesta virológica (por ejemplo, ARN del VHC indetectable en las semanas 2, 4, 8 ó 12) en los que logran una RVM.
    ? Porcentaje de pacientes con ARN del VHC indetectable en la SS12.
    ? Porcentaje de pacientes con ARN del VHC indetectable 72 semanas después de la aleatorización.
    ? Resistencia del VHC después del tratamiento que contiene BOC. Se obtendrán muestras de sangre en el momento basal y después del fracaso virológico del VHC, y al final del estudio se efectuará un análisis de resistencia en un único centro (Hospital Clínic, Barcelona).
    ? Seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 128
    F.1.3Elderly (>=65 years) No
    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 state128
    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
    no
    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 Decision2013-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
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