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    Summary
    EudraCT Number:2015-000111-41
    Sponsor's Protocol Code Number:M14-748
    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:2015-10-28
    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 number2015-000111-41
    A.3Full title of the trial
    An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects With Genotype 1 or 4 Chronic Hepatitis C Virus (HCV) Infection (ZIRCON)
    P/315/2013
    Estudio abierto, multicéntrico para evaluar la farmacocinética, la seguridad y la eficacia de ombitasvir (OBV), paritaprevir (PTV), ritonavir (RTV), con o sin dasabuvir (DSV) y con o sin ribavirina (RBV) en pacientes pediátricos con infección crónica por el virus de la hepatitis C (VHC) genotipo 1 o 4 (ZIRCON)
    P/315/2013
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of ombitasvir (OBV), paritaprevir (PTV), ritonavir (RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in pediatric subjects with genotype 1 or 4 chronic hepatitis C virus (HCV) infection.
    El propósito del estudio es evaluar la farmacocinética, la seguridad y la eficacia de ombitasvir (OBV), paritaprevir (PTV), ritonavir (RTV), con o sin dasabuvir (DSV) y con o sin ribavirina (RBV) en pacientes pediátricos con infección crónica por el virus de la hepatitis C (VHC) genotipo 1 o 4 (ZIRCON)
    A.4.1Sponsor's protocol code numberM14-748
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02486406
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/314/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901 20 01 03
    B.5.5Fax number+441628461153
    B.5.6E-mailabbvie_reec@abbvie.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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameViekirax 12.5 mg/75 mg/50 mg film-coated tablets
    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 INNOMBITASVIR
    D.3.9.1CAS number 1456607-70-7
    D.3.9.2Current sponsor codeOMBITASVIR
    D.3.9.3Other descriptive nameABT-267
    D.3.9.4EV Substance CodeSUB131058
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.2Current sponsor codeRITONAVIR
    D.3.9.3Other descriptive nameRITONAVIR
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPARITAPREVIR
    D.3.9.1CAS number 1456607-71-8
    D.3.9.2Current sponsor codePARITAPREVIR
    D.3.9.3Other descriptive nameABT-450
    D.3.9.4EV Substance CodeSUB166312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameExviera 250 mg film-coated tablets
    D.3.2Product code Dasabuvir; ABT-333
    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 INNDASABUVIR
    D.3.9.1CAS number 1456607-55-8
    D.3.9.2Current sponsor codeDasabuvir (ABT-333)
    D.3.9.3Other descriptive nameDASABUVIR
    D.3.9.4EV Substance CodeSUB131059
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 nameRibavirin
    D.3.2Product code Ribavirin
    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 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
    Chronic Hepatitis C infection
    Infección Crónica de Hepatitis C
    E.1.1.1Medical condition in easily understood language
    Hepatitis C Infection
    Infección 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 18.1
    E.1.2Level PT
    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
    ? In Part 2, the primary objectives are to evaluate the safety and efficacy (percentage of treatment-naïve subjects achieving SVR24) of OBV, PTV, RTV and DSV with or without RBV in HCV GT1-infected subjects and OBV, PTV, RTV with RBV in GT4-infected pediatric subjects with or without compensated cirrhosis.
    ? In Part 3, the primary and secondary objectives are to assess the durability of response for subjects who achieved SVR, to assess the persistence of specific HCV amino acid variants associated with drug resistance in subjects who experienced virologic failure, and to assess the impact of OBV, PTV, RTV with or without DSV coadministered with or without RBV on growth and development.
    En la Parte 2, el objetivo primario es evaluar la seguridad y eficacia (porcentaje de pacientes sin experiencia de tratamiento con una RVS24) de OBV, PTV, RTV, y DSV en pacientes pediátrico infectados con GT4 con o sin cirrosis compensada
    En la parte 3 , el objetivo primario y secundario es determinar la durabilidad de la respuesta en pacientes que alcanzaron la RVS, determinar la persistencia de variantes de aminoácidos específicas del VHC asociadas a resistencia a fármacos en pacientes que presentaron fracaso virológico y determinar el impacto de OBV, PTV, RTV con o sin DSV coadministrado con o sin RBV en el crecimiento y el desarrollo.
    E.2.2Secondary objectives of the trial
    ? Part 2 (Safety and Efficacy): To evaluate the percentage of treatment-naïve subjects with SVR12 and the percentage of treatment-naïve subjects with ALT normalization by the end of treatment.
    ? Part 3 (Long-term Follow-up): To assess the long term impact of OBV, PTV, RTV with or without DSV coadministered with or without RBV on growth and development.
    Parte 2 ( Seguridad y Eficacia) : Evaluar el porcentaje de pacientes sin experiencia de tratamiento con RVS12 y porcentaje de pacientes sin experiencia de tratamiento con normalización de ALT al final del tratamiento.
    Parte 3 ( Seguimiento a largo plazo): determinar a largo plazo el impacto de OBV, PTV, RTV con o sin DSV coadministrado con o sin RBV en el crecimiento y el desarrollo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The Pharmacogenetic Sub-Study procedure is described in the M14-748 Protocol. DNA samples from the Pharmacogenetic Sub-study may be sequenced and data analyzed for genetic factors contributing to the disease or to the subject's response to OBV, PTV, DSV in terms of pharmacokinetics, efficacy, tolerability, and safety. Such genetic factors may include genes for drug metabolizing enzymes, drug transport proteins, genes within the target pathway, genes believed to be related to the disease or to drug response. Some genes currently insufficiently characterized or unknown may be understood to be important at the time of analysis. The samples may be analyzed as part of a multi-study assessment of genetic factors involved in the response to OBV, PTV, DSV, drugs of this class, or the disease state. The samples may also be used for the development of diagnostic tests related to OBV, PTV, DSV, drugs of this class, or the disease state.
    El procedimiento del sub-estudio farmacogenético está descrito en el protocolo M14-748. Las muestras de ADN del subestudio de farmacogenética pueden ser secuenciadas y los datos analizados para factores genéticos contribuyendo a la enfermedad o a la respuesta de los pacientes a OBV,PTV,DSV en términos de farmacocinética, eficacia , tolerabilidad, y seguridad. Esos factores genéticos pueden incluir genes para enzimas que metabolizan fármacos, proteínas de transporte de fármacos , los genes para el camino del objetivo, los genes que se cree están relacionados con la enfermedad o la respuesta al fármaco. Algunos genes actualmente insuficientemente caracterizados o desconocido puede que se consideren importantes en el momento del análisis. Las muestras pueden ser analizadas como parte de una evaluación multi-estudio de los factores genéticos implicados en la respuesta al OBV, PTV, DSV, fármacos de esta clase, o el estado de la enfermedad. Las muestras también se pueden utilizar para el desarrollo de pruebas de diagnóstico relacionados con OBV, PTV, DSV, fármacos de esta clase, o el estado de enfermedad.
    E.3Principal inclusion criteria
    1. Positive anti-HCV Ab and HCV RNA greater than or equal to 1000 IU/mL at the time of screening.
    2. HCV genotype 1 or 4 for enrollment into Part 2.
    3. Parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and
    able to give assent, as appropriate for age and country.
    1. Ac anti-VHC positivos y ARN del VHC ? 1.000 UI/ml en el momento de la selección
    2. VHC genotipo 1 o 4 para la inclusión en la Parte 2.
    3. Padre(s)/tutor(es) legal(es) con el deseo y la capacidad de dar el consentimiento informado por escrito y paciente con el deseo y la capacidad de dar su asentimiento, según corresponda por edad y país
    E.4Principal exclusion criteria
    1. Women who are pregnant or breastfeeding.
    2. Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A, within 2 weeks or 10 half lives, whichever is longer, of the
    respective medication/supplement prior to study drug administration.
    3. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody (HIV Ab) test.
    4. Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any
    investigational or commercially available anti-HCV agents other than IFNs or RBV or receipt of any investigational product within 6 weeks prior to study drug administration.
    1. Mujeres embarazadas o en periodo de lactancia
    2. Uso de inductores e inhibidores fuertes conocidos (p. ej., gemfibrozilo) del citocromo P450 2C8 (CYP2C8) en pacientes tratados con dasabuvir, o inductores fuertes o moderados de CYP3A, en 2 semanas o 10 semividas, lo que sea más prolongado, del medicamento/suplemento correspondiente antes de la administración del fármaco del estudio.
    3. Resultado positivo en la prueba de antígeno de superficie de la hepatitis B (HbsAg) o anticuerpo anti-VIH (Ac VIH).
    4. Inclusión actual en otro estudio clínico intervencional, inclusión previa en este estudio, uso previo o actual de fármacos en investigación o comercializados frente al VHC distintos a IFN o RBV o recepción de algún fármaco en investigación en los 6 meses previos a la administración del fármaco del estudio
    E.5 End points
    E.5.1Primary end point(s)
    ? Part 2: The primary endpoint is the percentage of treatment-naïve subjects with SVR24
    ? Part 3: The primary endpoints of the Long-term Follow-up study are the percentage of subjects who relapse and the percentage of subjects who have new HCV infection at any time up to the last follow-up in this study out of subjects who achieved SVR in the previous study and enroll in this study.
    Parte 2: El objetivo principal es el porcentaje de pacientes sin experiencia de tratamiento con RVS24
    Parte 3 : El objetivo primario del seguimiento a largo plazo en el estudio es el porcentaje de pacientes que recaen y el porcentaje de pacientes que tienen nueva infección VHC en cualquier momento hasta el último seguimiento en este estudio de los pacientes que alcanzan RVS en el estudio previo y se incluyen en este estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim analysis on all the study data from Parts 1, 2 and 3 will occur after approximately 30 subjects enrolled in the ? 12 to 17 years age group in Part 2 complete PT Week 24 or prematurely discontinue from the study. An interim analysis on all the study data from Parts 1, 2 and 3 will occur after approximately 100 treatment-naïve subjects enrolled in Part 2 complete PT Week 24 or prematurely discontinue from the study. The same interim analysis will be repeated or updated once all subjects enrolled into Part 2 complete PT Week 24 or prematurely discontinue from the study.
    El análisis intermedio de todos los datos del estudio de la Parte 1, 2 y 3 ocurrirá después de que aproximadamente 30 pacientes del grupo ? 12 a 17 años en Parte 2 completen la semana PT o discontinúen prematuramente del estudio. Un análisis intermedio de todos los datos del estudio de la Parte 1, 2 y 3 ocurrirá después de que aproximadamente 100 pacientes sin experiencia de tratamiento incluidos en la Parte 2 completen semana 24 PT o discontinúen prematuramente del estudio. El mismos análisis intermedio se repetirá o actualizará cunado todos los pacientes incluidos en la Parte 2 completen Semana 24 PT o discontinúen prematuramente del estudio
    E.5.2Secondary end point(s)
    ? Part 2: The percentage of treatment-naïve subjects who achieve SVR12; and the percentage of treatment-naïve subjects with ALT .normalization during treatment, defined as ALT ? ULN at the final treatment visit for subjects with ALT > ULN at baseline
    ? Resistance: For subjects with virologic failure and HCV RNA > 1000 IU/mL, the variants at each amino acid position (by population, deep, and/or clonal nucleotide sequencing) at available post baseline time points compared to baseline and prototypic reference standard sequences will be summarized by DAA target genes and accompanying listings will be provided. Growth and Development: The following growth and development endpoints will be calculated through Post-Treatment Week 24 in Part 1 and Part 2, and in Part 3 for later visits. Growth rate at each post baseline visit (defined as change in height over change in age from the previous visit); Height z score; Waist circumference; Tanner staging
    Parte 2: El porcentaje de pacientes sin experiencia en el tratamiento que alcancen RVS12, y el porcentaje de pacientes sin experiencia en el tratamiento con normalización de la ALT durante el tratamiento, definida como ALT ? LSN en la visita final de tratamiento en pacientes con ALT > LSN en el periodo basal
    Resistencia: En pacientes con fracaso virológico y ARN del VHC > 1.000 UI/ml, las variantes en cada posición de aminoácidos (por secuenciación de nucleótidos poblacional, profunda o clonal) en intervalos de tiempo posbasales disponibles comparado con el periodo basal y secuencias estándares de referencia prototípicas se resumirán por genes objetivo de los AAD, con listas acompañantes. Crecimiento y desarrollo: Se calcularán los siguientes resultados de crecimiento y desarrollo hasta la semana 24 postratamiento en las Partes 1 y 2 y en la Parte 3 para visitas posteriores. Ritmo de crecimiento en cada visita posbasal (definido como el cambio en la estatura respecto al cambio de edad desde la visita previa).Puntuación z de estatura, Perímetro de la cintura, Estadios de Tanner.
    E.5.2.1Timepoint(s) of evaluation of this end point
    An interim analysis on all the study data from Parts 1, 2 and 3 will occur after approximately 30 subjects enrolled in the ? 12 to 17 years age group in Part 2 complete PT Week 24 or prematurely discontinue from the study. An interim analysis on all the study data from Parts 1, 2 and 3 will occur after approximately 100 treatment-naïve subjects enrolled in Part 2 complete PT Week 24 or prematurely discontinue from the study. The same interim analysis will be repeated or updated once all subjects enrolled into Part 2 complete PT Week 24 or prematurely discontinue from the study.
    El análisis intermedio de todos los datos del estudio de la Parte 1, 2 y 3 ocurrirá después de que aproximadamente 30 pacientes del grupo ? 12 a 17 años en Parte 2 completen la semana 24 PT o discontinúen prematuramente del estudio. Un análisis intermedio de todos los datos del estudio de la Parte 1, 2 y 3 ocurrirá después de que aproximadamente 100 pacientes sin experiencia de tratamiento incluidos en la Parte 2 completen semana 24 PT o discontinúen prematuramente del estudio. El mismos análisis intermedio se repetirá o actualizará cuando todos los pacientes incluidos en la Parte 2 completen Semana 24 PT o discontinúen prematuramente del estudio
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Part 2: Safety & Efficacy;
    Part 3: Dose Response
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Belgium
    Canada
    Germany
    Italy
    Puerto Rico
    Spain
    Switzerland
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.1.1Number of subjects for this age range: 132
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 132
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients 12 to 17 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 186
    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)
    All subjects who receive at least one dose of the DAAs will be monitored in the Long-Term Follow-Up Period for up to 168 weeks to assess the durability of response for subjects who achieved SVR and to assess the persistence of specific HCV amino acid variants associated with drug resistance in subjects who experienced virologic failure, and to assess the impact of OBV, PTV, RTV with or without DSV coadministered with or without RBV on growth and development.
    Todos los pacientes que reciban al menos una dosis de DAAs serán seguidos en el periodo de seguimiento a largo plazo hasta 168 semanas para determinar la duración de la respuesta de los pacientes que alcanzan RVS y para determinar la persistencia de variantes de aminoácidos específicas del VHC asociadas a resistencia a fármacos en pacientes que presentaron fracaso virológico y para determinar el impacto de OBV, PTV, RTV con o sin DSV coadministrado con o sin RBV en el crecimiento y desarrollo
    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 Decision2016-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-19
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