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    Summary
    EudraCT Number:2015-002866-21
    Sponsor's Protocol Code Number:BH29884
    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:2018-10-19
    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 number2015-002866-21
    A.3Full title of the trial
    A RANDOMIZED, MULTICENTER, OPEN-LABEL,
    PHASE III CLINICAL TRIAL TO EVALUATE THE
    EFFICACY, SAFETY, AND PHARMACOKINETICS
    OF PROPHYLACTIC RO5534262 VERSUS NO
    PROPHYLAXIS IN HEMOPHILIA A PATIENTS WITH
    INHIBITORS
    STUDIO CLINICO DI FASE III, RANDOMIZZATO,
    MULTICENTRICO, IN APERTO PER VALUTARE L’EFFICACIA,
    LA SICUREZZA E LA FARMACOCINETICA DELLA PROFILASSI CON RO5534262 RISPETTO A NESSUNA PROFILASSI IN PAZIENTI INIBITORI AFFETTI DA EMOFILIA A.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of
    Prophylactic RO5534262 versus No Prophylaxis in Hemophilia A Patients
    with Inhibitors
    Studio di Fase III per valutare l'efficacia, la sicurezza e le farmacocinetiche della profilassi di RO5534262 rispetto a nessuna profilassi in pazienti inibitori affetti da emofilia A
    A.3.2Name or abbreviated title of the trial where available
    A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic RO5534262 v
    Studio di Fase III per valutare l'efficacia, la sicurezza e le farmacocinetiche della profilassi di
    A.4.1Sponsor's protocol code numberBH29884
    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.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 12
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0
    B.5.5Fax number0
    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 Ro 553-4262/F03
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRo 553-4262/F03
    D.3.9.3Other descriptive nameRO5534262
    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 typeACE910 è un anticorpo monoclonale
    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 with Inhibitors
    PAZIENTI INIBITORI AFFETTI DA EMOFILIA A
    E.1.1.1Medical condition in easily understood language
    Hemophilia A is a genetic deficiency in blood clotting factor VIII, which causes increased bleeding. Inhibitors, however, prevent replacement factor VIII concentrates from controlling bleeds.
    L'emofilia A è una deficienza genetica del fattore VIII della coagulazione del sangue,che causa un aumento di sanguinamenti.Nei pazienti con inibitore le terapie con fattore VIII non sono in grado di
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of prophylactic RO5534262 compared with no prophylaxis in patients with hemophilia A with inhibitors
    valutare l’efficacia della profilassi con
    RO5534262 rispetto a nessuna profilassi in pazienti affetti da emofilia A con inibitori
    E.2.2Secondary objectives of the trial
    To evaluate
    - reduction in the number of bleeds
    - reduction in the number of joint bleeds and target joint bleeds
    - health-related quality of life
    - health status
    • To evaluate the overall safety of prophylactic RO5534262
    • To characterize the exposure of prophylactic RO5534262
    - Valutare l’efficacia nella riduzione del numero di sanguinamenti
    - Valutare l’efficacia nella riduzione del numero di sanguinamenti articolari nel tempo
    - Valutare lo stato di salute
    - Valutare la qualità della vita correlata alla salute
    - valutare la sicurezza globale di RO5534262 in profilassi
    - caratterizzare l'esposizione di RO5534262 in profilassi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 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 of any severity and documented
    history of high-titer inhibitor (i.e., >= 5 Bethesda Units)
    - Documentation of treatment with episodic or prophylactic bypassing
    agents for at least the last 24 weeks
    - Adequate hematologic function
    - Adequate hepatic function
    - Adequate renal function
    - For women who are not postmenopausal or surgically sterile:
    agreement to remain abstinent or use single or combined highly effective non-hormonal contraceptive methods
    - Età pari o superiore ai 12 anni al momento della visione del consenso informato
    - Peso corporeo ³ 40 kg al momento dello screening
    - Diagnosi di emofilia A congenita di qualsivoglia gravità e anamnesi documentata di inibitori ad alto titolo (³ 5 unità Bethesda)
    - Trattamento documentato con agenti bypassanti in via episodica o profilattica per almeno le ultime 24 settimane
    - Adeguata funzionalità ematologica
    - Adeguata funzionalità epatica
    - Adeguata funzionalità renale
    - Per le donne non in post-menopausa o sterili a seguito di intervento chirurgico:
    accordo a praticare l'astinenza o a utilizzare almeno un metodo contraccettivo non ormonale altamente efficace
    E.4Principal exclusion criteria
    Inherited or acquired bleeding disorder other than hemophilia A
    - Ongoing (or plan to receive during the study) immune tolerance
    induction therapy or prophylaxis with FVIII
    - History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the investigator's judgment
    - Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or signs of thromboembolic disease
    - Previous or concurrent autoimmune or connective tissue disease
    - History of hypersensitivity associated with monoclonal antibody therapies or components of the RO5534262 injection
    - Known HIV infection with CD4 count < 200 cells/microliter within 24 weeks 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
    - Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the study
    - Receipt of
    • RO5534262 in a prior investigational study
    • An investigational drug to treat or reduce the risk of hemophilic bleeds
    within 5 half-lives of last drug administration
    • A non-hemophilia-related investigational drug within last 30 days or 5
    half lives, whichever is shorter
    • An investigational drug concurrently
    - Unwillingness to use highly effective contraception methods for the specified duration in the protocol (females only, unless required otherwise by the local health authority)
    - Clinically significant abnormality on screening evaluations or laboratory tests that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient
    - Pregnancy or lactation, or intent to become pregnant during the study
    - Disturbo emorragico ereditario o acquisito diverso dall’emofilia A
    - Terapia di induzione di immunotolleranza o profilassi con FVIII in corso o pianificata per il
    periodo dello studio
    - Anamnesi di abuso di alcol o sostanze illecite nelle 48 settimane precedenti allo screening,
    secondo il giudizio dello sperimentatore
    - Trattamento in corso o pregresso per malattia tromboembolica (ad eccezione di pregressa
    trombosi associata a cateterismo per cui non sia attualmente in corso terapia antitrombotica) o segni di malattia tromboembolica
    - Malattia autoimmune o connettivopatia pregressa o concomitante
    - Anamnesi di ipersensibilità associata a terapie con anticorpi monoclonali o ai componenti dell’iniezione di RO5534262
    - Nota infezione da HIV con conta CD4 < 200 cellule/ml entro le 24 settimane precedenti allo screening
    - Uso di immunomodulatori per via sistemica (ad esempio interferone o rituximab)
    all’arruolamento oppure uso pianificato degli stessi nel corso dello studio, ad eccezione della terapia antiretrovirale
    - Malattia concomitante, trattamento o anomalie degli esami di laboratorio tali da interferire
    con l’adesione allo studio o che potrebbero precludere, secondo l’opinione dello
    sperimentatore o dello Sponsor, la partecipazione e il completamento dello studio da parte del paziente in condizioni di sicurezza, o potrebbero inficiare l’interpretazione dei risultati dello studio
    - Intervento chirurgico pianificato nel corso dello studio (ad esclusione di procedure minori quali estrazione dentaria o incisione e drenaggio)
    - Assunzione di:
    *RO5534262 nel corso di uno studio sperimentale precedente
    *Qualsiasi farmaco sperimentale volto a trattare o a ridurre il rischio di sanguinamenti emofiliaci entro 5 emivite dopo l’ultima somministrazione del farmaco
    *Qualsiasi farmaco sperimentale non correlato all’emofilia entro gli ultimi 30 giorni o entro le precedenti 5 emivite del farmaco, dei due il periodo più breve
    *Qualsiasi farmaco sperimentale concomitante
    - Rifiuto all’utilizzo di metodi contraccettivi altamente efficaci per la durata specificata nel protocollo (solo per le pazienti di sesso femminile, salvo diversamente indicato dalle autorità sanitarie locali)
    - Anomalie clinicamente significative alle valutazioni di screening o agli esami di laboratorio
    che, secondo l’opinione dello sperimentatore, potrebbero costituire un rischio aggiuntivo per la somministrazione del farmaco dello studio al paziente
    - Gravidanza o allattamento, o intenzione di programmare una gravidanza nel corso dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of bleeds over time
    valutare il numero di sanguinamenti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 24 weeks or discontinuation of study participation, whichever occurs first
    L’analisi di efficacia primaria sarà effettuata dopo che tutti i pazienti randomizzati avranno completato
    le 24 settimane di partecipazione allo studio oppure avranno interrotto la partecipazione allo studio, a
    seconda di quale dei due eventi si è verificato per primo,
    E.5.2Secondary end point(s)
    1. Number of bleeds over time
    2. Number of joint bleeds over time
    3. Number of target joint bleeds over time
    4. Quality of Life questionnaires
    5. Health status questionnaire
    6. Incidence and severity of adverse events
    7. Incidence of thromboembolic events
    8. Incidence of adverse events leading to drug discontinuation
    9. Incidence of severe hypersensitivity, anaphylaxis, and anaphylactoid events
    10. Incidence of anti-RO5534262 antibodies
    11. Plasma concentrations of RO5534262
    1. numero di sanguinamenti nel tempo
    2. numero di sanguinamenti articolari nel tempo
    3. numero di sanguinamenti articolari in
    articolazioni target nel tempo
    4. questionari sulla qualità della vita
    5. questionari sullo stato di salute
    6. incidenza e gravità degli eventi avversi
    7. incidenza di eventi tromboembolici
    8. incidenza di eventi avversi che conducono alla discontinuazione del farmaco in studio
    9. incidenza di eventi di grave ipersentibilità, anafilassi e eventi anafilattoidi
    10. incidenza di anticorpi anti-RO5534262
    11. concentrazione plasmatica di RO5534262
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Over 24 weeks or discontinuation of study participation, whichever
    occurs first
    4-5. At Weeks 24 and 48
    6-10. Up to the end of the study (estimated to be approximately 108
    weeks after the first enrolled patient)
    11. Upon starting RO5534262
    • Every week during Weeks 1−4
    • Every 2 weeks during Weeks 5−8
    • Every 4 weeks during Weeks 9−24
    • Every 8 weeks during Weeks 25−48
    • Every 12 weeks thereafter while on RO5534262, until the end of the
    study
    1-3 fino a 24 settimane o alla discontinuazione dello studio, quale si verifica prima
    4-5 alle settimane 24 e 48
    6-10 fino alla fine dello studio (calcolata approssimativamente 108 settimane dopo il primo paziente arruolato)
    11 fino all'assunzione di RO5534262
    *ogni settimana nelle settimane 1-4
    *ogni 2 settimane nelle settimane 5-8
    *ogni 4 settimane nelle settimane 9-24
    *ogni 8 settimane nelle settimane 25-48
    *ogni 12 settimane per le settimane successive di terapia con RO5534262, fino al termine dello studio
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Braccio B: no profillassi;
    Braccio C: controllo storico intrapaziente
    armB: no prophylaxis; armC: historical intrapatient control
    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 EEA19
    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
    Germany
    Italy
    Japan
    Korea, Republic of
    Poland
    Spain
    Taiwan
    United States
    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 patient completes the end of study, safety follow-up visit 24 weeks after discontinuing RO5534262, enrolls in an RO5534262 extension study, or is lost to follow-up.
    La conclusione del presente studio è definita come la data in cui l’ultimo paziente avrà completato la
    visita di follow-up di sicurezza di conclusione dello studio, da effettuarsi 24 settimane dopo
    l’interruzione di RO5534262, sarà arruolato in uno studio di estensione con RO5534262 o ancora
    sarà perso al follow-up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 1
    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: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 70
    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
    Lo Sponsor offrirà un accesso al farmaco RO5534262 dopo lo studio gratuito ai pazienti elegibili in accordo con Policy Globale Roche sull'accesso continuato al farmaco.
    La Policy Globale Roche è sidponibile al seguente sito 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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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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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