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    Summary
    EudraCT Number:2016-001094-33
    Sponsor's Protocol Code Number:BO39182
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2016-07-15
    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 number2016-001094-33
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL, PHASE III STUDY
    TO EVALUATE THE EFFICACY, SAFETY,
    PHARMACOKINETICS, AND
    PHARMACODYNAMICS OF EMICIZUMAB GIVEN
    EVERY 4 WEEKS (Q4W) IN PATIENTS WITH
    HEMOPHILIA A
    ESTUDIO DE FASE III, MULTICÉNTRICO Y SIN ENMASCARAMIENTO PARA EVALUAR LA EFICACIA, LA SEGURIDAD, LA FARMACOCINÉTICA Y LA FARMACODINÁMICA DEL EMICIZUMAB ADMINISTRADO CADA 4 SEMANAS EN PACIENTES CON HEMOFILIA A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients with Hemophilia A
    Estudio para evaluar la eficacia, seguridad, farmacocinetica y farmacodinamia de Emicizumab en pacientes con Hemofilia A.
    A.4.1Sponsor's protocol code numberBO39182
    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 SponsorRoche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportChugai Pharmaceutical Co. Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1221
    D.3 Description of the IMP
    D.3.1Product nameACE910
    D.3.2Product code RO5534262
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEmicizumab
    D.3.9.2Current sponsor codeRo 553-4262/F03
    D.3.9.3Other descriptive nameRO5534262 EMICIZUMAB
    D.3.9.4EV Substance CodeSUB168081
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRO5534262 (ACE910) is a recombinant humanized anti-activated blood coagulation Factor IX (anti-FIXa) and anti-blood coagulation Factor X (anti-FX) bispecific monoclonal antibody
    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
    Hemophilia A
    Hemofilia A
    E.1.1.1Medical condition in easily understood language
    Hemophilia A is a genetic deficiency of blood clotting factor VIII (FVIII), which causes increased bleeding.
    La hemofilia A es una deficiencia genetica de la cogulacion del factor VIII (FVIII) de la sangre que causa aumento de sangrados
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10018938
    E.1.2Term Haemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10053751
    E.1.2Term Hemophilia A with anti factor VIII
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    There is no formal hypothesis testing in this study:

    Expansion phase:
    Efficacy objectives
    •To evaluate the efficacy of prophylactic emicizumab in maintaining adequate control of bleeding
    •To evaluate the efficacy in reducing the number of joint bleeds over
    time, target joint bleeds over time, all bleeds over time
    •To evaluate the health-related quality of life of patients

    Safety Objectives
    •To evaluate the overall safety of emicizumab given Q4W in patients with hemophilia A
    Pharmacokinetic Objective
    •To characterize the pharmacokinetics of multiple Q4W doses of 6mg/kg emicizumab
    No hay evaluacion formal de hipotesis en este estudio:
    Fase de expansion:
    Objetivos de eficacia
    -Evaluar la eficacia del tratamiento profiláctico con emicizumab para mantener un control adecuado de las hemorragias.
    -Evaluar la eficacia en la reducción del número de hemorragias articulares a lo largo del tiempo, hemorragias en articulaciones diana a lo largo del tiempo y todas las hemorragias ocurridas a lo largo del tiempo.
    -Evaluar la calidad de vida relacionada con la salud
    Objetivos de seguridad
    Evaluar la seguridad global del emicizumab administrado C4S en pacientes con hemolia A
    -Caracterizar la farmacocinética de dosis repetidas una vez cada cuatro semanas de 6 mg/kg de emicizumab.
    E.2.2Secondary objectives of the trial
    Please note, there is no formal hypothesis testing in this study

    Run-in phase objectives:
    •To investigate the pharmacokinetics (PK) of emicizumab after single and multiple (every 4 weeks [Q4W]) subcutaneous (SC) administration of 6 milligram per Kilogram (mg/kg)
    •To assess the safety and tolerability of emicizumab after Q4W SC administration of 6 mg/kg
    •To explore the prophylactic effect of emicizumab in maintaining adequate control of bleeding
    •To investigate the effect of emicizumab on pharmacodynamic (PD) markers including (but not limited to) activated partial thromboplastin time, thrombin generation, and factor VIII (FVIII) activity
    Por favor, tenga en cuenta que no hay evaluacion formal de hipotesis en este estudio
    Obejtivos de la fase de preinclusión:
    -Investigar la farmacocinética del emicizumab después de la administración única y repetida (cada 4 semanas) por vía subcutánea (SC) de 6 mg/kg.
    -Evaluar la seguridad y la tolerabilidad del emicizumab después de la administración por vía subcutánea cada 4 semanas de 6 mg/kg.
    -Investigar el efecto profiláctico del emicizumab para mantener un control adecuado de las hemorragias.
    -Investigar el efecto del emicizumab sobre marcadores farmacodinámicos (FD) tales como (entre otros) TTPa, generación de trombina y actividad del factor VIII (FVIII).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Aged >=12 years
    •Body weight >= 40 kg at screening
    •Have severe congenital hemophilia A or hemophilia A with FVIII inhibitors
    Patients without FVIII inhibitors (< 0.6 Bethesda Units [BU]/milliliter [mL]) who completed successful immune tolerance induction (ITI) must have done so at least 5 years before screening and must have no evidence of inhibitor recurrence (permanent or temporary) indicated by detection of an inhibitor > 0.6 BU/mL since ITI
    •For patients to be enrolled into PK run-in cohort: Current episodic treatment (FVIII or bypassing agents) at the time of entry into this study and documentation of details of episodic treatment for at least 24 weeks prior to entry into this study
    •For patients to be enrolled into the expansion cohort: Documentation of details of prophylactic or episodic treatment and the number of bleeding episodes for at least 24 weeks prior to entry into this study. For patients on an episodic regimen, >= 5 bleeds in the prior 24 weeks, regardless of inhibitor status
    •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods that result in a failure rate of < 1percent per year during the treatment period and for at least 5 elimination half-lives (24 weeks) after the last dose of study drug
    •Adequate values of hematologic, hepatic, and renal function tests
    -Edad mínima de 12 años.
    -Peso ≥ 40 kg en el momento de la selección.
    -Diagnóstico de hemofilia A congénita grave o hemofilia A con inhibidores del FVIII.
    Los pacientes sin inhibidores del FVIII (< 0,6 BU/ml) que hayan completado la IIT con éxito deben haberlo hecho al menos 5 años antes de la selección y no deben tener signos de recidiva de los inhibidores (permanente o temporal), indicada por la detección de niveles de un inhibidor > 0,6 BU/ml desde la IIT
    -Para los pacientes que van a ser incluidos en la cohorte de preinclusión farmacocinética:
    Tratamiento episódico actual (FVIII o fármacos puente) en el momento de la entrada en este estudio y documentación detallada del tratamiento episódico durante al menos 24 semanas antes de la entrada en este estudio
    -Para los pacientes que van a ser incluidos en la cohorte de expansión:
    Documentación detallada del tratamiento profiláctico o episódico y del número de episodios de hemorragia al menos 24 semanas antes de la entrada en este estudio.
    Para los pacientes que estén recibiendo un tratamiento episódico, ≥ 5 hemorragias en las 24 semanas previas, independientemente de la situación relativa a los inhibidores
    -Para las mujeres con capacidad de procrear: compromiso de practicar la abstinencia (abstenerse de mantener relaciones heterosexuales) o usar métodos anticonceptivos muy eficaces que tengan una tasa de fracasos < 1% anual durante el periodo de tratamiento y durante al menos 5 semividas de eliminación (24 semanas) después de la última dosis del fármaco del estudio.
    -Valores adecuados de función hematológica, hepática y renal
    E.4Principal exclusion criteria
    •Inherited or acquired bleeding disorder other than hemophilia A
    •Ongoing or planned ITI therapy; patient in whom ITI has failed will be eligible with a 72-hour washout period prior to the first emicizumab administration
    •History of illicit drug or alcohol abuse within 48 weeks prior to screening
    •Previous (within the last 12 months) or current treatment for thromboembolic disease or signs of thromboembolic disease
    •Other conditions (e.g., certain autoimmune diseases) that may currently increase the risk of bleeding or thrombosis
    •History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
    •Known HIV infection with cluster of differentiation 4 (CD4) counts < 200 cells/microliter (μL) (CD4 counts >= 200 cell/μL will be permitted)
    •Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy
    •Concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study or pose an additional unacceptable risk in administering study drug to the patient
    •Women with a positive serum pregnancy test or pregnant/lactating women
    -Trastorno hemorrágico congénito o adquirido distinto de la hemofilia A.
    -Tratamiento de IIT en curso o programado; podrán participar pacientes que no hayan respondido a un tratamiento de IIT, con un período de lavado farmacológico de 72 horas antes de la administración de la primera dosis de emicizumab.
    -Antecedentes de alcoholismo o toxicomanía en las 48 semanas previas a la selección, a criterio del investigador
    -Tratamiento previo (en los últimos 12 meses) o actual por enfermedad tromboembólica o signos de enfermedad tromboembólica.
    -Otras enfermedades que puedan aumentar actualmente el riesgo de hemorragia o trombosis (por ejemplo, algunas enfermedades autoinmunitarias).
    -Antecedentes de hipersensibilidad clínicamente significativa asociada al tratamiento con anticuerpos monoclonales o a componentes de la inyección de emicizumab.
    -Infección conocida por el VIH con un recuento de CD4 < 200 células/μl (Se permite la infección por el VIH con un recuento de CD4 ≥ 200 células/μl.)
    -Tratamiento con inmunomoduladores sistémicos (como interferón) en el momento de la inclusión o previsión de tratamiento durante el período del estudio, con la excepción de los antirretrovirales.
    -Enfermedad, trastorno, anomalía importante en las evaluaciones de selección o en los análisis clínicos o tratamiento concomitantes que podrían interferir en la realización del estudio o que supondrían un riesgo adicional inaceptable en la administración del fármaco del estudio al paciente.
    -En las mujeres, resultado positivo en una prueba de embarazo en suero o mujeres en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: (Expansion phase)
    1.Number of bleeds over time
    2.Number of joint bleeds over time
    3.Number of target joint bleeds over time
    4.HRQoL of patients according to Haem-A-QoL (>= 18years) or Haemo-QoL_SF (ages 12−17 years) scores after 24 weeks
    5.EQ-5D-5L scores after 24 weeks
    6.Number of bleeds over time compared with the patient’s historical bleed rate over the last 24 weeks prior to study entry
    7.Number of days away from school/work
    8.Number of days hospitalized
    Eficacia: (Fase de expansion)
    1-Numero de hemorragias a lo largo del tiempo
    2-Numero de hemorragias articulares a lo largo del tiempo
    3-Numero de hemorragias en articulaciones diana a lo largo del tiempo
    4- Calidad de vida relacionada con la salud (CVRS) de los pacientes conforme a las puntuaciones obtenidas en los cuestionarios Haem-A-QoL (para pacientes de 18 años de edad o más) o Haemo-QoL_SF (para pacientes de 12 a 17 años) después de 24 semanas.
    5-Puntuación obtenida en el cuestionario EuroQoL (EQ-5D-5L) después de 24 semanas.
    6-Numero de hemorragias a lo largo del tiempo comparado con la tasa historica de hemorragias del paciente en las 24 semanas previas a la inclusion en el estudio.
    7-Numero de días perdidos de colegio/trabajo.
    8- Numero de días hospitalizado
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-3. Day 1 to study completion (24 weeks after emicizumab stop OR transfer to other emicizumab trial OR withdrawal)
    4-5. Week 1, 13, 25, then every 12 weeks until study completion (24 weeks after emicizumab stop OR transfer to other emicizumab trial OR withdrawal)
    6-8. Day 1 to study completion (24 weeks after emicizumab stop OR transfer to other emicizumab trial OR withdrawal)
    1-3. Dia 1 hasta final del estudio (24 semanas después de terminar el emicizumab o del traspaso a otro ensayo de emicizumab o de la retirada)
    4-5. Semanas 1, 13 ,25 y después cada 12 semanas hasta terminar el estudio (24 semanas después de terminar el emicizumab o del traspaso a otro ensayo de emicizumab o de la retirada)
    6-8. Dia 1 hasta final del estudio (24 semanas después de terminar el emicizumab o del traspaso a otro ensayo de emicizumab o de la retirada)
    E.5.2Secondary end point(s)
    PK endpoints: (Run-in and expansion phase)
    1.Time to maximum observed plasma concentration
    2.Area under the plasma concentration (AUC)-time curve over a dosing interval
    3.Pre-dose (trough) plasma concentrations of emicizumab (Expansion phase)
    Safety endpoints: (Run-in and expansion phase)
    4.Incidence and severity of adverse events
    5.Incidence and severity of thromboembolic events
    6.Changes in physical examination findings and vital signs
    7.Incidence of laboratory abnormalities
    8.Incidence and severity of injection-site reactions
    9.Incidence of adverse events leading to drug discontinuation
    10.Incidence of severe hypersensitivity, anaphylaxis, and anaphylactoid events
    11.Incidence of clinically significant levels of anti-emicizumab antibodies
    12.Incidence of de novo development of FVIII inhibitors (non-inhibitor population)
    Efficacy endpoint (Run-in phase):
    13.Maintaining adequate control of bleeding
    Pharmacodynamics (Run-in and expansion phase)
    14.PD marker analyses
    Objetivos farmacocinéticos: (fases de preinclusión y expansion)
    1-Tiempo hasta la concentracion plasmatica maxima observada
    2-Area bajo la curva plasmatica (ABC) concentración-tiempo para un intervalo de dosificacion
    3-Concentraciones plasmaticas pre-dosis (Cmin) de Emicizumab (fase de expansion)
    Objetivos de seguridad: (fases de preinclusión y expansion)
    4-Incidencia y severidad de acontecimientos adversos
    5-Incidencia y severidad de eventos tromboembólicos
    6-Cambios en los hallazgos de las exploraciones físicas y de los signos vitales
    7-Incidencia de las anormalidades de laboratorio
    8-Incidencia y severidad de las reacciones en el punto de inyección
    9-Incidencia de los acontecimientos adversos que llevan a la discontinuación del farmaco
    10-Incidencia de eventos severos de hipersensibilidad, anafilaxis y reacciones anafilactoides
    11-Incidencia de anticuerpos anti-emicizumab en niveles clinicamente significativos
    12.Incidencia del desarrollo de novo de inhibidores del FVIII (poblacion que no está con inhibidores)
    Objetivos de eficacia: (Fase de preinclusion)
    13- Mantenimiento de un control adecuado de las hemorragias
    Farmacodinamicos (fases de preinclusión y expansion)
    14.Analisis de marcadores farmacodinamicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Day 1 until study completion (24 weeks after emicizumab stop OR transfer to other emicizumab trial OR withdrawal)
    4-13. Up to study completion (24 weeks after emicizumab stop OR transfer to other emicizumab trial OR withdrawal)
    14. Day 1 until study completion (24 weeks after emicizumab stop OR transfer to other emicizumab trial OR withdrawal)
    1-3. Dia 1 hasta final del estudio (24 semanas después de terminar el emicizumab o del traspaso a otro ensayo de emicizumab o de la retirada)
    4-13. Hasta final del estudio (24 semanas después de terminar el emicizumab o del traspaso a otro ensayo de emicizumab o de la retirada)
    14-Dia 1 hasta final del estudio (24 semanas después de terminar el emicizumab o del traspaso a otro ensayo de emicizumab o de la retirada)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Tasas de hemorragias historicas
    historical bleed rates
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Japan
    Spain
    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
    LPLV
    UVUP
    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 months8
    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 months8
    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: 4
    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: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 46
    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)
    The Sponsor will offer post-trial access to the study drug (RO5534262)
    free of charge to eligible patients in accordance with the Roche Global
    Policy on Continued Access to Investigational Medicinal Product.
    The Roche Global Policy on Continued Access to Investigational
    Medicinal Product is available at the following Web site:
    http://www.roche.com/policy_continued_access_to_investigational_
    medicines.pdf
    El promotor ofrecerá acceso al fármaco del estudio (RO5534262) al final del ensayo de manera gratuita a los pacientes elegibles segun la politica global de Roche de acceso continuado a los medicamentos en investigación. La politica global de Roche de acceso continuado a los medicamentos en investigación esta disponible en la siguiente página web:
    http://www.roche.com/policy_continued_access_to_investigational_
    medicines.pdf
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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