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    Summary
    EudraCT Number:2016-004366-25
    Sponsor's Protocol Code Number:MO39129
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    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
    STUDIO CLINICO DI FASE IIIB, A SINGOLO BRACCIO, MULTICENTRICO, PER LA VALUTAZIONE DELLA SICUREZZA E DELLA TOLLERABILIT¿ DELLA PROFILASSI CON EMICIZUMAB IN PAZIENTI AFFETTI DA EMOFILIA A CON INIBITORI
    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
    STUDIO CLINICO PER LA VALUTAZIONE DELLA SICUREZZA E DELLA TOLLERABILIT¿ DELLA PROFILASSI CON EMICIZUMAB IN PAZIENTI AFFETTI DA EMOFILIA A CON INIBITORI
    A.3.2Name or abbreviated title of the trial where available
    A Clinical Trial to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A
    STUDIO CLINICO PER LA VALUTAZIONE DELLA SICUREZZA E DELLA TOLLERABILIT¿ DELLA PROFILASSI CON EMICIZU
    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 SponsorF. 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 number000000
    B.5.5Fax number000000
    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 codeRO553-4262
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 is a recomb hum anti-FIXa and anti -FX
    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
    Emofilia 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.
    Emofilia A ¿ una deficienza genetica del fattore VIII della coagulazione (FVIII), che causa aumento del sanguinamento.
    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 10053751
    E.1.2Term Hemophilia A with anti factor VIII
    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 10060612
    E.1.2Term Hemophilia A
    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
    Valutare la sicurezza e la tollerabilit¿ complessiva della somministrazione di emicizumab in profilassi
    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
    - Valutare l'efficacia della somministrazione di emicizumab in profilassi
    -Valutare l'immunogenicit¿ di emicizumab
    -Ottenere dati di farmacocinetica su emicizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - As per the investigator's judgment, a 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 or paper
    - 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
    - Secondo il parere dello sperimentatore, volontà e capacità di seguire le indicazioni riguardo alle visite pianificate, ai piani terapeutici,alle analisi di laboratorio e alle altre procedure dello studio, tra cui i questionari per gli esiti riferiti dai pazienti (PRO, atient-reported outcome) e i diari dei sanguinamenti compilati su un dispositivo elettronico o cartaceo
    - Età pari o superiore a 12 anni alla data del consenso informato
    -Peso corporeo =40 kg alla data dello screening
    - Diagnosi di emofilia A congenita con inibitori persistenti anti-FVIII
    - Trattamento documentato con agenti bypassanti o concentrati di FVIII negli ultimi 6 mesi (ondemand o profilassi). La profilassi deve essere interrotta al più tardi un giorno prima dell'inizio della somministrazione di emicizumab
    -Adeguata funzionalità ematologica, epatica e renale
    - Per le donne potenzialmente fertili: accettazione a praticare l’astinenza (astenersi dai rapporti eterosessuali) o a utilizzare metodi contraccettivi altamente efficaci, che determinino un tasso di insuccesso <1% all'anno, durante il periodo di trattamento e per almeno cinque emivite di eliminazione (24 settimane) dopo l'ultima dose di 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 emicizumab (females only)
    -Disturbo emorragico ereditario o acquisito diverso da emofilia A
    - Terapia di induzione di immunotolleranza (ITI, immune tolerance induction) in corso (o previsione di somministrazione durante lo studio); (i regimi profilattici con FVIII e/o agenti bypassanti devono essere interrotti prima dell'arruolamento). I pazienti sottoposti a terapia ITI saranno eleggibili dopo aver portato a termine un periodo di washout di 72 ore prima della prima somministrazione di emicizumab
    - Anamnesi di abuso di droghe illegali o alcool nei 12 mesi precedenti allo screening, secondo il parere dello sperimentatore
    - Rischio elevato di TMA (per es. anamnesi medica pregressa o familiare di TMA), secondo il parere dello sperimentatore
    - Trattamento precedente (negli ultimi 12 mesi) o in corso per la malattia tromboembolica (fatta eccezione per trombosi precedente correlata al catetere per la quale non sia attualmente in corso un trattamento antitrombotico) o segni attuali di malattia tromboembolica
    - Altre condizioni (per es. alcune malattie autoimmuni) che potrebbero aumentare il rischio di emorragia o di trombosi
    - Anamnesi di reazione da ipersensibilità clinicamente significativa associata a terapie a base di anticorpi monoclonali o ai componenti dell'iniezione di emicizumab
    - Infezione accertata da virus dell'immunodeficienza umana (HIV) con conta CD4 <200 cellule/µl nei 6 mesi precedenti allo screening
    - Uso di immunomodulatori sistemici (per es. interferone o rituximab) alla data dell'arruolamento o uso previsto durante lo studio, fatta eccezione per la terapia antiretrovirale
    - Concomitante malattia, trattamento o anomalia nelle analisi cliniche di laboratorio, che potrebbe interferire con la conduzione dello studio o che, secondo il parere dello sperimentatore o dello Sponsor, impedirebbe una partecipazione sicura del paziente allo studio, il completamento dello studio da parte del paziente oppure l'interpretazione dei risultati dello studio
    - Trattamento con:
    Emicizumab in uno studio sperimentale precedente
    Un farmaco sperimentale per trattare o ridurre il rischio di emorragie emofiliache entro cinque emivite dall'ultima somministrazione del farmaco
    Un farmaco sperimentale non legato al trattamento dell'emofilia negli ultimi 30 giorni o nelle ultime cinque emivite, a seconda di quale periodo sia il più breve
    Qualsiasi altro farmaco concomitante
    - Gravidanza o allattamento al seno o intenzione di iniziare una gravidanza durante lo studio
    - Risultato positivo del test di gravidanza sul siero nei 7 giorni precedenti all'inizio di emicizumab (solo per le donne).
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of all adverse events including thromboembolic events, microangiopathic hemolytic anemia or, TMA (e.g. hemolytic uremic syndrome), systemic hypersensitivity, anaphylaxis, and anaphylactoid events
    2. Changes in physical examination findings, vital signs, and laboratory parameters
    1. Incidenza e severità di tutti gli eventi avversi, compresi eventi
    tromboembolici, anemia emolitica microangiopatica, o microangiopatia trombotica (TMA) (es. sindrome uremica), ipersensibilità sistemica, anafilassi ed eventi
    anafilattoidi
    ¿¿¿Variazioni nei risultati dell'esame fisico, nei segni vitali e nei
    parametri di laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 2 years
    fino a 2 anni
    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. Valutare l'efficacia della somministrazione di emicizumab in profilassi sulla base del numero di sanguinamenti nel tempo
    2. Valutare l'HRQoL dei pazienti in base ai punteggi Haem-A-QoL (et¿ =18 anni) o Haemo-QoL-SF (et¿ 12-17 anni) nel tempo
    3. Valutare lo stato di salute dei pazienti in base ai punteggi EQ-5D-5L nel tempo
    4. Valutare le preferenze dei pazienti nei confronti del regime con emicizumab rispetto al regime precedente utilizzato
    5. Valutare l'incidenza e la significativit¿ clinica degli anticorpi antiemicizumab
    6. Ottenere dati di farmacocinetica su emicizumab in momenti temporali definiti
    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 (da Settimana-4 a Settimana 0), Settimana 1, Settimana 2, Settimana 3, Settimana 5, Mese 3, Mese 6, Mese 9, Mese 12, Mese 15, Mese 18, Mese 21, Mese 24, al follow up di sicurezza.
    2-3 Settimana 1, Mese 3, Mese 6, Mese 12, Mese 18, Mese 24
    4. fino a 2 anni.
    5. Settimana 1, Settimana 5, Mese 3, Mese 6, Mese 12, Mese 18, Mese 24, al follow up di sicurezza
    6. Settimana 1, Settimana 2, Settimana 3, e Settimana 5, Mese 3, Mese 6, Mese 12, Mese 18, Mese 24, al follow up di sicurezza
    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 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
    NA
    NA
    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 concerned10
    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 Information not present in EudraCT
    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
    Brazil
    Canada
    Colombia
    Dominican Republic
    Guatemala
    Israel
    Mexico
    Panama
    Russian Federation
    Saudi Arabia
    Belgium
    Bulgaria
    Denmark
    Finland
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    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.
    Per conclusione dello studio si intende la data in cui ha luogo l'ultima visita dell'ultimo paziente (ovvero LPLV). Lo studio terminer¿ quando tutti i pazienti saranno stati trattati con emicizumab per 2
    anni oppure prima, qualora dovesse verificarsi uno dei seguenti eventi documentati: Ritiro del consenso OPPURE Completamento della visita di follow up di sicurezza 24 settimane dopo l'interruzione di emicizumab OPPURE Perdita al follow up OPPURE Decesso.
    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.1.1.1In 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 state20
    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 offrirà accesso continuo a emicizumab a pazienti che hanno dimostrato beneficio dimostrabile durante lo studio(misurato in base a risposta clinica sostenuta e/o miglioramento dei sintomi clinici).L'accesso continuo all'IMPverrà fornito gratuitamente tramite trial di estensione OpenLabel, un programma di accessoPost-Trial,programmi di supporto per pazienti locali o altri meccanismi di accesso locale,in conformità con laPolitica globale Rochesull'accesso continuato ai medicinali sperimentali
    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 Decision2017-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    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.

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