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    Summary
    EudraCT Number:2014-004250-34
    Sponsor's Protocol Code Number:TMC435HPC2018
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-11
    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 number2014-004250-34
    A.3Full title of the trial
    A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
    Estudio Fase 2, abierto, con una sola rama de tratamiento, para estudiar la eficacia, seguridad, tolerabilidad y farmacocinética de 12 semanas de tratamiento con Simeprevir y Daclatasvir en pacientes con infección crónica por el genotipo 1b o 4 del virus de la hepatitis C y con disfunción renal grave o enfermedad renal terminal en hemodiálisis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis
    Estudio de eficacia, seguridad, tolerabilidad y farmacocinética de 12 semanas de tratamiento con Simeprevir y Daclatasvir en pacientes con infección crónica por el genotipo 1b o 4 del virus de la hepatitis C y con disfunción renal grave o enfermedad renal terminal en hemodiálisis.
    A.3.2Name or abbreviated title of the trial where available
    NEPTUNE
    NEPTUNO
    A.4.1Sponsor's protocol code numberTMC435HPC2018
    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 S.A
    B.5.2Functional name of contact pointGlobal Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@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 (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.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 OLYSIO
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 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: 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 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.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 and 4 Infection
    Infección por el genotipo 1b o 4 del virus de la hepatitis C
    E.1.1.1Medical condition in easily understood language
    Hepatitis C Virus (HCV) genotype-1 and 4 Infection
    Infección por el genotipo 1b o 4 del 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 17.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy (SVR12) of a 12-week treatment regimen containing SMV and DCV in subjects with chronic HCV genotype 1b or 4 infection and either severe renal impairment or ESRD on hemodialysis.
    El objetivo principal es evaluar la eficacia (respuesta virológica sostenida 12 semanas después del final real del tratamiento del estudio, RVS12) de un tratamiento de 12 semanas con SMV y DCV en pacientes con infección crónica por el genotipo 1b o 4 del VHC y disfunción renal grave o enfermedad renal terminal (ERT) en hemodiálisis.
    E.2.2Secondary objectives of the trial
    To evaluate safety and tolerability of a 12-week treatment regimen containing SMV and DCV.
    To evaluate on-treatment virologic response of a 12-week treatment regimen containing SMV and DCV.
    To evaluate the efficacy (SVR4 and SVR24) of a 12-week treatment regimen containing SMV and DCV.
    To evaluate the frequency of on-treatment failure during a 12-week treatment regimen containing SMV and DCV.
    To evaluate the frequency of viral relapse after a 12-week treatment regimen containing SMV and DCV.
    To assess changes from baseline in the HCV NS3/4A and NS5A sequence in subjects not achieving SVR.
    To evaluate plasma PK of SMV in subjects with severe renal impairment or ESRD on hemodialysis using a population PK modeling approach.

    Additional secondary objectives are listed in the protocol
    Evaluar la seguridad y tolerabilidad de un tratamiento de 12 semanas con SMV y DCV.
    Evaluar la repuesta virológica durante un tratamiento de 12 semanas con SMV y DCV.
    Evaluar la eficacia (RVS4 y RVS24) de un tratamiento de 12 semanas con SMV y DCV.
    Evaluar la frecuencia de fracaso durante el tratamiento de 12 semanas con SMV y DCV.
    Evaluar la frecuencia de recidivas virales tras un tratamiento de 12 semanas con SMV y DCV.
    Evaluar las variaciones respecto al momento basal en las secuencias de NS3/4A y NS5A del VHC en los pacientes que no alcanzan la RVS.
    Evaluar la farmacocinética (FC) plasmática de SMV en pacientes con disfunción renal grave o ERT en hemodiálisis mediante un método de modelado para FC poblacional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or woman, between 18 and 70 years of age, inclusive, at screening
    - Hepatitis C Virus (HCV genotype): HCV genotype 1b or 4 (determined at screening)
    - Plasma HCV RNA: Greater than (>) 10,000 international unit per milliliter (IU/mL) (determined at screening)
    - HCV disease status: FibroScan less than (<) 14.5 kilopascal (kPa), performed within 3 months prior to screening, or between screening and baseline (Day 1), and no history or signs orsymptoms of decompensated liver disease. In participants with FibroScan >12.5 kPa, absence of findings suspicious for hepatocellular carcinoma documented by an abdominal ultrasound, performed within 3 months prior to screening, or between screening and baseline (Day 1)
    - HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
    -Varones o mujeres de 18 a 70 años de edad, inclusive, en la selección.
    -Genotipo del VHC: Genotipo 1b o 4 del VHC (determinado en la selección)
    -ARN plasmático del VHC:>10 000 UI/ml (determinado en la selección)
    -Estado de la enfermedad por VHC: FibroScan < 14,5 kPa, realizado dentro del plazo de 3 meses antes de la selección, o entre la selección y el momento basal (día 1), y sin antecedentes, signos ni síntomas de hepatopatía descompensada.
    En pacientes con un FibroScan > 12,5 kPa, ausencia de hallazgos sospechosos de carcinoma hepatocelular documentados por una ecografía abdominal, realizada dentro del plazo de 3 meses antes de la selección o entre ésta y el momento basal (día 1).
    -Antecedentes de tratamiento del VHC: Pacientes sin tratamiento previo contra el VHC, definidos como aquellos que nunca han recibido tratamiento contra el VHC con un fármaco aprobado o en investigación (incluidas vacunas); O BIEN Pacientes con tratamiento previo contra el VHC, definidos como aquellos que han recibido tratamiento previo contra el VHC con cualquier régimen a base de interferón (pegilado, IFN[Peg]) (con o sin ribavirina [RBV] y sin incluir un antiviral de acción directa [DAA]). La última dosis del tratamiento previo contra el VHC se deberá haber administrado como mínimo 2 meses antes de la selección.
    E.4Principal exclusion criteria
    - Infection/co-infection: HCV genotype other than 1b or 4, Human immunodeficiency virus type 1 or 2
    - Liver disease of non-HCV etiology: Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, hepatitis B (hepatitis B surface antigen positive), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson?s disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator
    - Hepatic decompensation: History or evidence of clinical hepatic decompensation (presence of ascites, bleeding varices or hepatic encephalopathy)
    - Organ transplantation/renal replacement therapy: Prior organ transplant (other than cornea, hair transplant or skin graft), except for history of kidney transplant with subsequent renal failure requiring hemodialysis and for which use of immunosuppressants has been discontinued; Considered for kidney transplant or imminent renal replacement therapy (including intermittent hemodialysis; continuous hemofiltration and hemodialysis; and peritoneal dialysis) for participants with severe renal impairment within a time frame that overlaps with study participation
    - Key protocol defined laboratory abnormalities
    -Infección/Coinfección: Genotipo que no sea 1b o 4 del VHC; Virus de la inmunodeficiencia humana de tipo 1 o 2.
    -Cualquier hepatopatía con una etiología distinta del VHC:Cualquier indicio de hepatopatía con una etiología distinta del VHC. Esto incluye, aunque no exclusivamente, hepatitis A aguda, hepatitis B (antígeno de superficie del virus de la hepatitis B), hepatopatía relacionada con fármacos o alcohol, hepatitis autoinmunitaria, hemocromatosis, enfermedad de Wilson, déficit de alfa-1 antitripsina, esteatohepatitis no alcohólica, cirrosis biliar primaria o cualquier otra hepatopatía no debida al VHC que el investigador considere de importancia clínica.
    -Descompensación hepática: Antecedentes o signos de descompensación hepática clínica (presencia de ascitis, varices hemorrágicas o encefalopatía hepática).
    -Trasplante de órganos o terapia de sustitución renal: Trasplante previo de órganos (excepto trasplante de córnea, trasplante capilar o injerto cutáneo), excepto en el caso de antecedentes de trasplante renal con posterior insuficiencia renal que requiera hemodiálisis y para la que se haya interrumpido el uso de inmunodepresores; Se esté valorando el trasplante renal o terapia de sustitución renal inminente (incluida la hemodiálisis intermitente, hemofiltración continua y hemodiálisis, y diálisis peritoneal) para pacientes con disfunción renal grave en un periodo de tiempo que coincida con la participación en el estudio.
    -Anomalías analíticas claves definidas en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)
    La proporción de pacientes con respuesta virológica sostenida 12 semanas después del final del tratamiento del estudio, (RVS12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after end of treatment (EOT) (Week 12 of follow-up phase)
    12 semanas después del final real del tratamiento del estudio (Semana 12 de la fase de seguimiento).
    E.5.2Secondary end point(s)
    1 - Percentage of Participants With On-treatment Response
    2 - Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)
    3 - Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)
    4 - Percentage of Participants With on-treatment Failure
    5 - Percentage of Participants With Viral Relapse
    6 - Change From Baseline in Hepatitis C Virus (HCV) Nonstructural Protein 3/4A (NS3/4A) and Nonstructural Protein 5A (NS5A) Sequence in Participants not Achieving SVR
    7 - Change From Baseline in HCV Symptom and Impact Questionnaire version 4 (HCVSIQv4) Overall Body Symptom score
    1- La proporción de pacientes con respuesta durante el tratamiento.
    2-La proporción de pacientes con respuesta virológica sostenida en la semana 4 tras finalización de tratamiento (RVS4)
    3- La proporción de pacientes con respuesta virológica sostenida en la semana 24 tras finalización de tratamiento (RVS24)
    4- La proporción de pacientes con fracaso durante el tratamiento
    5-La proporción de pacientes con recidiva viral.
    6-Las variaciones respecto al momento basal en las secuencias de NS3/4A y NS5A del VHC en los pacientes que no alcancen la RVS.
    7-Las variaciones respecto al momento basal en la puntuación del cuestionario de síntomas generales que afectan al organismo HCV-SIQv4 (Overall Body Symptom).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Baseline up to EOT (Week 12)
    2 - 4 weeks after EOT (Week 4 of follow-up phase)
    3 - 24 weeks after EOT (Week 24 of follow-up phase)
    4 - Baseline up to EOT (Week 12), 12 weeks after EOT (Week 12 of follow-up phase)
    5 - EOT (Week 12) until end of followup phase (Week 24 of follow-up phase)
    6 - Baseline until end of follow-up phase (Week 24 of follow-up phase)
    7 - Baseline until end of follow-up phase (Week 24 of follow-up phase)
    1- Desde el momento basal a final de tratamiento (Semana 12)
    2-4 semanas tras finalización de tratamiento (Semana 4 de la fase de seguimiento)
    3-24 semanas tras finalización de tratamiento (Semana 24 de la fase de seguimiento)
    4-Desde el momento basal a final de tratamiento (Semana 12), 12 semanas después tras finalización de tratamiento (Semana 12 de fase de seguimiento).
    5-Finalización de tratamiento (Semana 12) hasta fin de la fase de seguimiento (Semana 24 de la fase de seguimiento)
    6-Desde el momento basal a final de la fase de seguimiento (Semana 24 de la fase de seguimiento).
    7-Desde el momento basal a final de la fase de seguimiento (Semana 24 de la fase de seguimiento).
    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 Yes
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA10
    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 patient last visit
    La última visita del último paciente
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state15
    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
    Tratamiento según práctica clínica habitual para dicha indicación.
    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 Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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