Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-004366-25
    Sponsor's Protocol Code Number:MO39129
    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:2017-06-22
    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 number2016-004366-25
    A.3Full title of the trial
    A SINGLE-ARM, MULTICENTER PHASE IIIB CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF PROPHYLACTIC EMICIZUMAB IN HEMOPHILIA A PATIENTS WITH INHIBITORS
    ENSAYO CLÍNICO EN FASE IIIB MULTICÉNTRICO, CON UN SOLO GRUPO DE TRATAMIENTO, PARA EVALUAR LA SEGURIDAD Y TOLERANCIA DEL TRATAMIENTO PROFILÁCTICO CON EMICIZUMAB EN PACIENTES CON HEMOFILIA A QUE PRESENTAN INHIBIDORES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors
    Ensayo clinico para evaluar la seguridad y tolerabilidad de Emicizumab profilactico en pacientes con Hemofilia A con inhibidores.
    A.4.1Sponsor's protocol code numberMO39129
    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 SA Soc Unipersonal que realiza el ensayo en España y que actúa como representante de 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.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-mailspain.start_up_unit@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 codeRO553-4262
    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, which causes increased bleeding.
    La Hemofilia A es una deficiencia genetica del factor VIII de coagulación que causa un aumento de las hemorragias
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060612
    E.1.2Term Hemophilia A
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To evaluate the overall safety and tolerability of prophylactic administration of emicizumab
    Evaluar la seguridad general y la tolerancia de la administración profiláctica de emicizumab
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of prophylactic administration of emicizumab
    •To evaluate the immunogenicity of emicizumab
    •To obtain emicizumab PK data
    •Evaluar la eficacia de la administración profiláctica de emicizumab
    •Evaluar la inmunogenicidad de emicizumab
    •Obtener datos sobre la FC de emicizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the patient-reported outcome (PRO) questionnaires and bleed diaries through the use of an electronic device, as per the investigator’s judgment
    -Aged 12 years or older at the time of informed consent
    -Body weight >=40 kg at the time of screening
    -Diagnosis of congenital hemophilia A with persistent inhibitors against FVIII
    -Documented treatment with bypassing agents or FVIII concentrates in the last 6 months (on-demand or prophylaxis). Prophylaxis needs to be discontinued the latest by a day before starting emicizumab
    -Adequate hematologic, hepatic, and renal function
    -For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method with a failure rate of <1% per year during the treatment period and for at least five elimination half-lives (24 weeks) after the last dose of emicizumab
    -Tener disposición y capacidad para cumplir con las visitas planificadas, los planes de tratamiento, las pruebas de laboratorio y otros procedimientos del estudio, incluyendo los cuestionarios de los resultados percibidos por el paciente (PRO) y los diarios de hemorragias utilizando un dispositivo electrónico, de acuerdo con el criterio del investigador
    -Tener ≥ 12 años de edad en el momento de otorgar el consentimiento informado
    -Peso corporal ≥40 kg en el período de selección
    -Hemofilia A congénita diagnosticada, con inhibidores persistentes contra FVIII
    -Tratamiento documentado con agentes bypass o concentrados de FVIII en los 6 últimos meses (a demanda o con fines profilácticos). El tratamiento profiláctico se debe suspender, como máximo, un día antes de empezar a administrar emicizumab
    -Función hematológica, hepática y renal adecuada
    -Para las mujeres potencialmente fértiles: deben comprometerse a practicar la abstinencia sexual (es decir, a no mantener relaciones heterosexuales) o a utilizar un método anticonceptivo altamente eficaz con una tasa de fallos de <1% al año, durante el período de tratamiento y durante al menos cinco vidas medias de eliminación (24 semanas) después de la administración de la última dosis de emicizumab
    E.4Principal exclusion criteria
    -Inherited or acquired bleeding disorder other than hemophilia A
    -Ongoing (or plan to receive during the study) immune tolerance induction (ITI) therapy (prophylaxis regimens with FVIII and/or bypassing agents must be discontinued prior to enrollment). Patients receiving ITI therapy will be eligible following the completion of a 72-hour washout period prior to the first emicizumab administration
    -History of illicit drug or alcohol abuse within 12 months prior to screening, as per the investigator’s judgment
    -High risk for thrombotic microangiopathy (TMA) (e.g., have a previous medical or family history of TMA), as per the investigator’s judgment
    -Previous (in the past 12 months) or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or current signs of thromboembolic disease
    -Other conditions (e.g., certain autoimmune diseases) that may increase the risk of bleeding or thrombosis
    -History of clinically significant hypersensitivity reaction associated with monoclonal antibody therapies or components of the emicizumab injection
    -Known human immunodeficiency virus (HIV) infection with CD4 count <200 cells/μL within 6 months prior to screening
    -Use of systemic immunomodulators (e.g., interferon or rituximab) at enrollment or planned use during the study, with the exception of antiretroviral therapy
    -Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study or that would, in the opinion of the investigator or Sponsor, preclude the patient’s safe participation in and completion of the study or interpretation of the study results
    -Receipt of:
    •Emicizumab in a prior investigational study
    •An investigational drug to treat or reduce the risk of hemophilic bleeds within five half-lives of last drug administration
    •A non-hemophilia-related investigational drug within last 30 days or five half-lives, whichever is shorter
    •Any concurrent investigational drug.
    -Pregnancy or lactation, or intent to become pregnant during the study
    -Positive serum pregnancy test result within 7 days prior to initiation of study drug (females only)
    -Presentar trastornos hemorrágicos hereditarios o adquiridos distintos de hemofilia A
    -Pacientes que estén recibiendo (o que tengan previsto recibir durante el estudio) terapia de inducción de inmunotolerancia (ITI) (el tratamiento profiláctico con FVIII y/o agentes bypass se debe suspender antes de la inclusión en el estudio). Los pacientes que estén recibiendo terapia ITI serán elegibles para el estudio tras completar un período de lavado farmacológico de 72 horas antes de la administración de la primera dosis de emicizumab
    -Antecedentes de consumo de sustancias ilegales o abuso de alcohol en los 12 meses previos a la selección, de acuerdo con el criterio del investigador
    -Pacientes con alto riesgo de microangiopatia trombótica (MAT) (p. ej. con antecedentes clínicos o familiares de MAT), de acuerdo con el criterio del investigador
    -Tratamiento previo (en los 12 últimos meses) o actual para enfermedad tromboembólica (exceptuando trombosis previa asociada a catéter que no esté siendo tratada actualmente con antitrombóticos) o signos de enfermedad tromboembólica en la actualidad
    -Otros trastornos (p. ej. determinadas enfermedades autoinmunes) que puedan aumentar el riesgo de hemorragia o trombosis
    -Antecedentes de reacciones de hipersensibilidad clínicamente significativas asociadas con anticuerpos monoclonales o los componentes de la inyección de emicizumab
    -Infección por virus de inmunodeficiencia humana (VIH) confirmada, con recuento de CD4 <200 células/μl en los 6 meses previos a la selección
    -Uso de inmunomoduladores sistémicos (p. ej. interferón o rituximab) en el momento de la inclusión en el estudio o previsto durante el estudio, exceptuando terapia antirretroviral
    -Enfermedad concurrente, tratamiento concomitante o anomalías en las pruebas de laboratorio clínico que podrían interferir en la realización del estudio o que, de acuerdo con la opinión del investigador o el promotor, impedirían al paciente participar con seguridad en el estudio y completarlo o dificultarían la interpretación de los resultados del estudio
    -Administración de:
    •Emicizumab en un estudio de investigación previo
    •Cualquier fármaco en investigación utilizado para tratar o reducir el riesgo de hemorragias hemofílicas durante un período de cinco vidas medias después de la administración de la última dosis del fármaco
    •Cualquier fármaco en investigación para indicaciones distintas a hemofilia en los 30 últimos días o durante un período de cinco vidas medias, dependiendo de lo que sea más corto
    •Cualquier fármaco en investigación utilizado de forma concomitante.
    -Pacientes embarazadas o en período de lactancia o que tengan intención de quedarse embarazadas durante el estudio
    -Resultado positivo en la prueba de embarazo en suero en los 7 días previos al inicio del tratamiento con el fármaco del estudio (sólo en mujeres)
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of adverse events including thromboembolic, TMA, systemic hypersensitivity, anaphylaxis, and anaphylactoid events
    2. Changes in physical examination findings, vital signs, and laboratory parameters
    1. Incidencia y severidad de los acontecimientos adversos, incluyendo eventos tromboembólicos, microangiopatía trombótica (MAT), reacciones sistémicas de hipersensibilidad, anafilácticas y anafilactoides
    2. Cambios en los hallazgos de la exploración física, las constantes vitales y los parámetros de laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 2 years
    Hasta un máximo de 2 años
    E.5.2Secondary end point(s)
    1. Number of bleeds over time
    2. Hemophilia Adult Quality of Life Questionnaire (Haem-A-QoL) (>=18 y) or Hemophilia Quality of Life Short Form (Haemo-QoL-SF) (ages 12−17) scores over time
    3. EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) scores over time
    4. Patient preference for the emicizumab regimen compared with the previous regimen used
    5. The incidence and clinical significance of anti-emicizumab antibodies
    6. Pharmacokinetics data for emicizumab at defined timepoints
    1. Número de hemorragias en el transcurso del tiempo
    2. Cuestinario de calidad de vida de Hemofilia del adulto (Haem-A-QoL) (pacientes ≥ 18 años) o Formulario corto de calidad de vida de hemofilia (Haemo-QoL-SF )(pacientes de edades comprendidas entre 12 y 17 años) en el transcurso del tiempo
    3. Cuestionario EuroQoL de cinco- dimensiones-cinco niveles (EQ-5D-5L) en el transcurso del tiempo
    4. Preferencia de los pacientes por el régimen de administración de emicizumab en comparación con el utilizado previamente
    5. Incidencia y la significación clínica de los anticuerpos anti-emicizumab
    6. Datos Farmacocinéticos de emicizumab en momentos específicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Screening (Week-4 to Week 0), Week 1, Week 2, Week 3, Week 5, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, at safety follow-up
    2-3. Week 1, Month 3, Month 6, Month 12, Month 18, Month 24
    4. Up to 2 years
    5. Week 1, Week 5, Month 3, Month 6, Month 12, Month 18, Month 24, at safety follow-up
    6. Week 1, Week 2, Week 3, and Week 5, Month 3, Month 6, Month 12, Month 18, Month 24, at safety follow-up
    1. Screening (Semana 4 a Semana 0), Semana 1, Semana 2, Semana 3, Semana 5, Mes 3, Mes 6, Mes 9, Mes 12, Mes 15, Mes 18, Mes 21, Mes 24 y seguimiento de seguridad
    2-3. Semana 1, Mes 3, Mes 6, Mes 12, Mes 18, Mes 24
    4. Hasta un máximo de 2 años
    5. Semana 1, Semana 5, Mes 3, Mes 6, Mes 12, Mes 18, Mes 24, seguimiento de seguridad
    6. Semana 1, Semana 2, Semana 3, y Semana 5, Mes 3, Mes 6, Mes 12, Mes 18, Mes 24 y seguimiento de seguridad
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Colombia
    Denmark
    Dominican Republic
    Finland
    Germany
    Guatemala
    Hungary
    Israel
    Italy
    Mexico
    Netherlands
    Panama
    Poland
    Portugal
    Romania
    Russian Federation
    Saudi Arabia
    Spain
    Sweden
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of this study is defined as the date when the last remaining patient has completed the last visit (i.e., LPLV). The study will end when all patients have been treated with emicizumab for 2 years, or earlier, if one of the following is documented: Withdrawal of consent OR Completed the 24 week safety follow-up visit 24 weeks after discontinuing emicizumab OR Lost to follow-up OR Death.
    El final del estudio se define como la fecha cuando el ultimo paciente participante ha completado la última visita (es decir, UVUP). El estudio terminará cuando todos los pacientes hayan sido tratados con emicizumab durante 2 años o antes si uno de los siguientes supuestos se documenta: Retirada de consentimiento O completa la visita de seguimiento de seguridad de 24 semanas 24 semanas después de discontinuar emicizumab O perdida de seguimiento O muerte
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 60
    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: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 134
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 100
    F.4.2.2In the whole clinical trial 200
    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)
    Roche will offer continued access to emicizumab to patients who have
    shown a demonstrable benefit during this study (as measured by
    sustained clinical response and/or improvement in clinical symptoms).
    Continued Access to the IMP will be provided free of charge, via an
    Open Label Extension trial, a Post-Trial Access Program, local Patient
    Support Programs, or other local access mechanisms, in accordance
    with the Roche Global Policy on Continued Access to Investigational
    Medicinal Product
    Roche ofrecerá acceso continuado a Emicizumab a pacientes que hayan mostrado un beneficio demostrable durante el estudio (medido por una respuesta clinica sostenida y/o mejora en los sintomas clinicos). El acceso continuado al IMP será proporcionado gratuitamente via un estudio de extensión abierto, un programa de acceso post-ensayo, programas locales de apoyo a pacientes u otros mecanismos de acceso locales de acuerdo con la politica global de Roche de acceso a farmacos en investigación
    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 Decision2017-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-19
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat May 24 04:42:13 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA