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    Summary
    EudraCT Number:2013-002726-23
    Sponsor's Protocol Code Number:TMC435HPC3016
    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:2013-10-01
    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 number2013-002726-23
    A.3Full title of the trial
    Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation
    Estudio abierto de fase 2 para investigar la farmacocinética, la eficacia, la seguridad y la tolerabilidad de la combinación de simeprevir (TMC435), daclatasvir (BMS-790052) y ribavirina (RBV) en pacientes con infección crónica recurrente por el genotipo 1b del virus de la hepatitis C después de un trasplante de hígado ortotópico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients with Recurrent Chronic Hepatitis C Genotype 1b Infection after Orthotopic Liver Transplantation
    Un estudio de farmacocinética, eficacia, seguridad, tolerabilidad de la combinación de Simeprevir (TMC435), daclatasvir (BMS-790052) y ribavirina (RBV) en pacientes con hepatitis C crónica recurrente genotipo 1b infección tras el trasplante hepático ortotópico
    A.4.1Sponsor's protocol code numberTMC435HPC3016
    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 SponsorJanssen R&D, Ireland
    B.1.3.4CountryBelgium
    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 supportJanssen R&D, Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV- Clinical Registry Group
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameJNJ-38733214-AAA - capsule, hard (G028) - 150mg
    D.3.2Product code TMC435 (or R494617)
    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 INNSimeprevir
    D.3.9.2Current sponsor codeTMC435
    D.3.9.3Other descriptive nameJNJ-38733214-AAA
    D.3.9.4EV Substance CodeSUB26723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 nameDaclatasvir
    D.3.2Product code BMS-790052 / DCV
    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 INNdaclatasvir
    D.3.9.2Current sponsor codeBMS-790052
    D.3.9.3Other descriptive nameDACLATASVIR
    D.3.9.4EV Substance CodeSUB34092
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 200 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameCopegus 200 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 INNribavirin
    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: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameJNJ-38733214-AAA - capsule, hard (G019) - 150mg
    D.3.2Product code TMC435 (or R494617)
    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 INNSimeprevir
    D.3.9.2Current sponsor codeTMC435
    D.3.9.3Other descriptive nameJNJ-38733214-AAA
    D.3.9.4EV Substance CodeSUB26723
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 (HCV) genotype-1b Infection
    Virus de Hepatitis C (VHC) genotipo-1b
    E.1.1.1Medical condition in easily understood language
    Hepatitis C Virus (HCV) genotype-1 Infection
    Virus de Hepatitis C (VHC) genotipo-1 Infección
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives are:
    - To evaluate the effect of steady-state simeprevir and daclatasvir on the steady-state pharmacokinetics of cyclosporine and tacrolimus when administered as a regimen containing simeprevir (150 mg qd), daclatasvir (60 mg qd) and RBV (1000 to 1200 mg per day) in post-OLT subjects with recurrent HCV genotype 1b infection
    - To evaluate the efficacy of a 24-week treatment regimen containing simeprevir, daclatasvir, and RBV with respect to the proportion of HCV genotype 1b infected post-OLT subjects achieving sustained virologic response 12 weeks after EOT (SVR12)
    Los objetivos principales son:
    - Para evaluar el efecto de simeprevir de estado estacionario y daclatasvir sobre la farmacocinética en estado estacionario de la ciclosporina y el tacrolimus cuando se administra como un régimen que contiene simeprevir (150 mg qd), daclatasvir (60 mg qd) y RBV (1000 a 1200 mg por día ) en sujetos post-OLT con infección por el VHC de genotipo 1b recurrente
    - Para evaluar la eficacia de un régimen de tratamiento de 24 semanas que contiene simeprevir, daclatasvir, y RBV con respecto a la proporción de VHC de genotipo 1b sujetos infectados después de la OLT lograron una respuesta virológica sostenida 12 semanas después del EOT (RVS12)
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate the pharmacokinetic profile of simeprevir and daclatasvir during a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
    - To determine the need for dose adjustment of cyclosporine and tacrolimus during a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
    - To evaluate the efficacy of a 24-week treatment regimen containing simeprevir, daclatasvir, and RBV with respect to the proportion of HCV genotype 1b infected post-OLT subjects achieving sustained virologic response 4 and 24 weeks after EOT (SVR4 and SVR24, respectively)
    - To evaluate safety and tolerability of a 24-week treatment regimen containing simeprevir, daclatasvir and RBV in post-OLT subjects with recurrent HCV genotype 1b infection
    Objetivos secundarios :
    Para evaluar el perfil farmacocinético de simeprevir y daclatasvir durante un régimen de tratamiento de 24 semanas que contiene simeprevir, daclatasvir y RBV en pacientes post-OLT con infección por el genotip 1b del VHC recurrente.Para determinar la necesidad de ajustar la dosis de ciclosporina y tacrolimus durante un régimen de tratamiento de 24 sem. que contiene simeprevir, daclatasvir y RBV en pacientes post-OLT con infección por el VHC de genotipo 1b recurrente
    Para evaluar la eficacia de un régimen de tratamiento de 24 semanas que contiene simeprevir, daclatasvir, y RBV con respecto a la proporción de VHC de genotipo 1b sujetos infectados después de la OLT lograron una respuesta virológica sostenida 4 y 24 semanas después del EOT(SVR4 y RVS24 respectivamente)
    Para evaluar la seguridad y la tolerabilidad de un régimen de tratamiento de 24 semanas que contiene simeprevir, daclatasvir y RBV en sujetos post-OLT con infección por VHC de genotipo 1b recurrente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Liver transplant between 6 months and 10 years prior to the screening visit
    -Hepatitis C virus (HCV) genotype 1 subtype b infection
    - Screening HCV ribose nucleic acid level greater than 10,000 IU per milliliter
    - HCV treatment-naïve participants must not have received post-OLT treatment with any approved or investigational drug for the treatment of HCV
    - Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine or tacrolimus for more than 3 months prior to the screening visit
    - El trasplante de hígado entre los 6 meses y 10 años antes de la visita de selección
    -Virus de la hepatitis C (VHC) genotipo 1 subtipo B
    - Detección de ácido nucleico del VHC nivel ribosa mayor de 10.000 UI por mililitro
    - VHC participantes sin tratamiento previo no deben haber recibido un tratamiento post-OLT con cualquier fármaco aprobado o en fase de investigación para el tratamiento del VHC
    - Recepción de la terapia inmunosupresora estable (es decir, ningún cambio en la dosis en el último mes) con ciclosporina o tacrolimus durante más de 3 meses antes de la visita de selección
    E.4Principal exclusion criteria
    - Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)
    - Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis
    - Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavarin
    - Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)
    - Multi-organ transplant that included heart, lung, pancreas, or kidney
    - La evidencia de descompensación hepática aguda o crónica después del trasplante de hígado (como ascitis, várices sangrantes o encefalopatía hepática)
    - Cualquier enfermedad hepática de etiología no-HCV, incluyendo la evidencia actual de rechazo del injerto, excepto la presencia de esteatosis hepática
    - Cualquier otra enfermedad clínicamente significativa que, en opinión del investigador se ve agravada por los efectos conocidos de ribavirina
    - Coinfección con VHC de genotipo de otro genotipo 1b, el VIH tipo 1 o 2 (positivo VIH-1 o VIH-2 prueba de anticuerpos en la selección), y el virus de la hepatitis B (antígeno de superficie de hepatitis B positivo)
    - Trasplante de varios órganos que incluye corazón, pulmón, páncreas o riñón
    E.5 End points
    E.5.1Primary end point(s)
    1 - Number of participants with a sustained virologic response (SVR)12 Weeks after the end of treatment
    2 - Maximum Observed Plasma Concentration (Cmax) of cyclosporine and tacrolimus
    3 - Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[last]) of cyclosporine and tacrolimus
    1 - Número de participantes con una respuesta virológica sostenida (RVS) 12 semanas después del final del tratamiento
    2 - La concentración plasmática máxima (Cmax) de ciclosporina y tacrolimus
    3 - Área bajo la curva concentración-tiempo de curva de cero cuando en cuando a última concentración cuantificable Observado (AUC [última]) de ciclosporina y tacrolimus
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - Week 36
    2 - Baseline, Week 2, 4, 8, 12
    3 - Baseline, Week 2, 4, 8, 12
    1 - Semana 36
    2 - Línea de base, Semana 2, 4, 8, 12
    3 - Línea de base, Semana 2, 4, 8, 12
    E.5.2Secondary end point(s)
    1 - Maximum Observed Plasma Concentration (Cmax) of simprenavir and daclatasvir
    2 - Time to Reach Maximum Observed Plasma Concentration (Tmax) of simprenavir and daclatasvir
    3 - Predose (trough) concentration (C0h) of simprenavir and daclatasvir
    4 - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of simprenavir and daclatasvir
    5 - Number of participants with dose adjustment of cyclosporine and tacrolimus during treament with
    regimen simeprevir, daclatasvir and RBV
    6 - Number of patients with a sustained virological response SVR4 after the end of treatment
    7 - Number of participants with a sustained virologic response SVR24 after the end of treatment
    8 - Number of participants with adverse events
    9 - Number of participants with Undetectable HCV RNA (less than 25 IU/milliliter undetectable) and HCV RNA less than 25 IU/milliliter detectable
    10 - Number of participants with HCV RNA level less than 100 IU/milliliter
    11 - Number of participants with ontreatment failure after treatment with regimen simeprevir, daclatasvir and
    RBV
    12 - Number of participants with viral relapse after treatment with regimen simeprevir, daclatasvir and RBV
    13 - Number of participants with HCV NS3/4A and NS5A sequences
    1 - La concentración plasmática máxima (Cmax) de simprenavir y daclatasvir
    2 - El tiempo para alcanzar la concentración plasmática máxima (Tmáx) de simprenavir y daclatasvir
    3 - Predosis (valle) de concentración (C0h) de simprenavir y daclatasvir
    4 - Área Bajo la Curva del Cero Tiempo al final del intervalo de dosificación (AUCtau) de simprenavir y daclatasvir
    5 - Número de participantes con un ajuste de dosis de ciclosporina y tacrolimus durante Treament con
    régimen simeprevir, daclatasvir y RBV
    6 - Número de pacientes con SVR4 respuesta virológica sostenida después del final del tratamiento
    7 - Número de participantes con una respuesta virológica sostenida SVR24 después del final del tratamiento
    8 - Número de participantes con eventos adversos
    9 - Número de participantes con ARN del VHC indetectable (menos de 25 UI / mililitro indetectable) y de ARN del VHC de menos de 25 UI / mililitro detectable
    10 - Número de participantes con nivel de ARN del VHC inferior a 100 UI / ml
    11 - Número de participantes con insuficiencia ontreatment después del tratamiento con el régimen simeprevir, daclatasvir y
    RBV
    12 - Número de participantes con recaída viral después del tratamiento con el régimen simeprevir, daclatasvir y RBV
    13 - Número de participantes con VHC NS3/4A y secuencias NS5A
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Baseline, Week 2, 4, 8, 12
    2 - Baseline, Week 2, 4, 8, 12
    3 - Baseline, Week 2, 4, 8, 12
    4 - Baseline, Week 2, 4, 8, 12
    5 - Part 1: Days 10 to 14
    6 - Week 28
    7 - Week 48
    8 - Up to Week 48
    9 - Weeks 2, 4, 12 and 24
    10 - Week 4
    11 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
    12 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
    13 - Screening, baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24
    1 - Línea de base, Semana 2, 4, 8, 12
    2 - Línea de base, Semana 2, 4, 8, 12
    3 - Línea de base, Semana 2, 4, 8, 12
    4 - Línea de base, Semana 2, 4, 8, 12
    5 - Parte 1: días 10 al 14 de
    6 - Semana 28
    7 - Semana 48
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - tolerability
    - HCV NS3/4A and NS5A sequences determination
    - tolerabilidad
    - NS3/4A de VHC NS5A y la determinación de secuencias
    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 No
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Last visit of the last subject
    última visita del último sujeto
    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 months6
    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 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: 38
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    expected normal treatment of that condition
    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 Decision2013-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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