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    Summary
    EudraCT Number:2015-001049-10
    Sponsor's Protocol Code Number:M14-726
    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:2015-07-31
    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 number2015-001049-10
    A.3Full title of the trial
    Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir with Ribavirin (RBV) in Adult Patients with GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma
    Estudio abierto para evaluar la seguridad y eficacia de la combinación de Ombitasvir, Paritaprevir/r ± Dasabuvir con ribavirina (RBV) en pacientes adultos con infección crónica por el virus de la hepatitis C de GT1 o GT4, y con Respuesta al tratamiento previo de un Carcinoma Hepatocelular en estadio inicial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or without Dasabuvir and with Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults with Successfully Treated Early Stage Hepatocellular Carcinoma
    Estudio para evaluar la seguridad y eficacia de Ombitasvir/Paritaprevir/r con o sin Dasabuvir y con Ribavirina en adultos con infección crónica por el virus de la hepatitis C de genotipo 1 o 4, y tratados con respuesta de un Carcinoma Hepatocelular en estadio inicial
    A.4.1Sponsor's protocol code numberM14-726
    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 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 AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628773355
    B.5.5Fax number+441628672566
    B.5.6E-maileu-clinical-trials@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.2.1.1.1Trade name Ombitasvir/Paritaprevir/Ritonavir 12.5 mg/75 mg/50 mg film-coated tablets
    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 nameOmbitasvir/Paritaprevir/Ritonavir
    D.3.2Product code ABT-450/r/ABT-267
    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 codeABT-267
    D.3.9.3Other descriptive nameOMBITASVIR
    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.3.9.4EV 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 (ABT-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.2.1.1.1Trade name Dasabuvir
    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 nameDasabuvir
    D.3.2Product code 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 por el virus de la hepatitis C
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C Infection
    Infección crónica por el virus de la hepatitis C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    The primary objectives of this study are to assess the safety and efficacy the percentage of subjects achieving a 12-week sustained virologic response ([SVR12] [HCV ribonucleic acid {RNA} < lower limit of quantification {LLOQ} 12 weeks after the last dose of the study drugs]) of coformulated ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with ribavirin (RBV) for 12 or 24 weeks in adult patients with documented complete response to prior treatment of early stage hepatocellular carcinoma and either genotype 1 or 4 chronic HCV infection.
    Los objetivos principales de este estudio consisten en evaluar la seguridad y eficacia, mediante el porcentaje de sujetos que logren una respuesta virológica sostenida a las 12 semanas ([RVS12] [ácido ribonucleico {ARN} del VHC < límite inferior de cuantificación {LIC} 12 semanas después de la última dosis de los fármacos del estudio]), de ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) en coformulación, con o sin dasabuvir (DSV) administrado junto con ribavirina (RBV), durante 12 o 24 semanas en pacientes adultos con respuesta completa documentada al tratamiento de un carcinoma hepatocelular (CHC) en estadio inicial y con infección crónica por VHC de genotipo 1 o 4.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess:
    1. the percentage of subjects with virologic failure during treatment,
    2. the percentage of subjects with relapse post-treatment,
    3. the percentage of subjects with long term clinical outcomes during a period of 3 years of follow-up, including de novo HCC lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above, among subjects who were treated for HCV and achieved SVR12 and those who did not, and
    4. the percentage of subjects with recurrent HCV infection post liver transplant out of all subjects with liver transplant during the study stratified by duration of treatment and HCV suppression status prior to transplant (as appropriate).
    Los objetivos secundarios consisten en evaluar:

    1. Porcentaje de sujetos con fracaso virológico durante el tratamiento.
    2. Porcentaje de sujetos con recidiva después del tratamiento.

    3. Porcentaje de sujetos con resultados clínicos a largo plazo durante un período de 3 años de seguimiento, entre ellos, lesiones nuevas de CHC, descompensación hepática, trasplante hepático inesperado, muerte relacionada con el hígado o cualquiera de los anteriores, de entre los pacientes tratados para el VHC y que logren una RVS12, y los que no.

    4. Porcentaje de sujetos con infección recurrente por el VHC tras el trasplante de hígado de entre todos los que se sometan a un trasplante hepático durante el estudio, estratificados en función de la duración del tratamiento y el estado de supresión del VHC antes del trasplante (según proceda).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion:
    1. Male or female, at least 18 years of age at time of screening.
    2. Chronic HCV infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection.
    3. Early stage HCC diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
    4. Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening.
    5. Documented complete response to HCC treatment.
    6. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
    Criterios de inclusion principales:
    1. Hombres o mujeres, con una edad mínima de 18 años en el momento de selección.
    2. Infección crónica por el VHC antes de la inclusión en el estudio con unos resultados analíticos en el periodo de selección que indiquen genotipo del VHC 1 o 4.
    3. Diagnóstico de CHC de estadio temprano basado en el rasgo distintivo característico del CHC (hipervascular en la fase arterial con lavado en la fase venosa portal o diferida).
    4. Cirrosis compensada, definida como una puntuación de Child-Pugh de 5 o 6 en la visita de selección
    5. Respuesta completa documentada al tratamiento del CHC
    6. Las mujeres deben ser post-menopáusicas durante más de dos años o esteriles quirúrgicamente, o practicar formas aceptables de control de natalidad.
    E.4Principal exclusion criteria
    Main Exclusion:
    1. Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in subjects receiving OBV/PTV/r with and without DSV, strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in subjects receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-DAA and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
    2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
    3. Patients not eligible for liver transplantation due to significant cardio vascular or pulmonary disease.
    4. Clinically significant abnormalities, other than HCV infection, in a subject with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator.
    Criterios de exclusión principales:
    1. Uso de inductores potentes o moderados del citocromo P450 3A (CYP3A) en los sujetos tratados con OBV/PTV/r con y sin DSV, inductores e inhibidores potentes (por ejemplo, gemfibrozilo) del citocromo P450 2C8 (CYP2C8) en los sujetos tratados con OBV/PTV/r y DSV, medicamentos contraindicados con ritonavir o RBV (en los tratados con RBV en las 2 semanas, o el equivalente a 10 semividas del fármaco (si se conoce), lo que suponga más tiempo, previas a la administración del fármaco del estudio. En cuanto a los medicamentos contraindicados con una pauta de 2 o 3 antivirales de acción directa (AAD) de AbbVie, consulte la sección relativa a información sobre prescripción recomendada de las fichas técnicas locales.
    2. Resultado positivo en el análisis de antígeno de superficie del virus de la hepatitis B (HbsAg) o de anticuerpos contra el virus de la inmunodeficiencia humana (Ac anti-VIH).
    3. Pacientes no aptos para trasplante de hígado por una enfermedad cardiovascular o pulmonar importante.
    4. Anomalías concomitantes de importancia clínica, aparte de la infección por el VHC, en sujetos con HCC, basado en la historia médica, exploración física, constantes vitales, resultados del laboratorio, electrocardiograma, que en opinión del investigador convierten al sujeto en un candidato inadecuado para participar en este estudio o recibir la pauta farmacológica.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug).
    El criterio de valoración principal será el porcentaje de sujetos con RVS12 (ARN del VHC < LIC, 12 semanas después de la última dosis real de los fármacos del estudio).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drugs
    12 semanas después de la última dosis del fármaco
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    1. the percentage of subjects with virologic failure during treatment,
    2. the percentage of subjects with relapse post-treatment, and
    3. the percentage of subjects with long term clinical outcomes during a period of 3 years of follow-up, including de novo HCC lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above, among subjects who were treated for HCV and achieved SVR12 and those who did not achieve SVR12.
    4. the percentage of subjects with recurrent HCV infection post liver transplant out of all subjects with liver transplant during the study stratified by duration of treatment and HCV suppression status prior to transplant (as applicable).
    Los criterios de valoración secundarios serán:
    1. Porcentaje de sujetos con fracaso virológico durante el tratamiento.
    2. Porcentaje de sujetos con recidiva después del tratamiento.
    3. Resultados clínicos a largo plazo de interés durante un período de 3 años de seguimiento, definidos como: lesiones de CHC de novo, descompensación hepática, trasplante de hígado inesperado, muerte relacionada con el hígado o cualquiera de las anteriores, entre los sujetos que hayan recibido tratamiento contra el VHC y hayan logrado una RVS12, y los que no.
    4. Porcentaje de sujetos con infección recurrente por el VHC tras el trasplante de hígado de entre todos los que se sometan a un trasplante hepático durante el estudio, estratificados en función de la duración del tratamiento y el estado de supresión del VHC antes del trasplante (según proceda).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Day 1 to end of treatment, and end of treatment to 168 weeks post treatment
    Tratamiento desde Dia 1 al final del periodo de tratamiento, y final del tratamiento hasta 1688 semanas de periodo posterior al tratamiento
    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 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.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Canada
    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
    Última Visita del Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 60
    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)
    Upon completion of treatment, subjects are followed for 168 weeks after the last dose of study drug. Additional plans for treatment will be at the investigator's discretion.
    Tras la finalización del tratamiento los sujetos son seguidos durante 168 semanas tras la última dosis de la medicación de estudio. Los planes adicionales para el tratamiento serán a discreción del investigador principal
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-02-03
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