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    Summary
    EudraCT Number:2015-005521-39
    Sponsor's Protocol Code Number:241502
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-02-04
    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 number2015-005521-39
    A.3Full title of the trial
    A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
    Studio di Fase 3, multicentrico, in aperto, sull’efficacia e la sicurezza del Fattore VIII suino ricombinante privo di dominio B (BAX 802) in soggetti affetti da emofilia A congenita con inibitori del Fattore VIII sottoposti a procedure chirurgiche o ad altre procedure invasive
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Drug BAX 802 in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
    Studio sull'efficacia e sulla sicurezza del farmaco BAX 802 soggetti affetti da emofilia A congenita con inibitori del Fattore VIII sottoposti a procedure chirurgiche o ad altre procedure invasive
    A.3.2Name or abbreviated title of the trial where available
    BAX 802 in Congenital Hemophilia A with Inhibitors
    BAX 802 nella CHA con inibitori
    A.4.1Sponsor's protocol code number241502
    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 SponsorBAXALTA INNOVATIONS GMBH
    B.1.3.4CountryAustria
    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 supportBaxalta Innovation GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxalta Innovation GmbH
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressIndusreiestrasse 67
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1221
    B.5.3.4CountryAustria
    B.5.4Telephone number00431201002472930
    B.5.5Fax number00431201002475733
    B.5.6E-mailnondisponibile@nd.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OBIZUR
    D.2.1.1.2Name of the Marketing Authorisation holderBaxalta Innovations GmbH
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNSusoctocog alfa
    D.3.9.2Current sponsor codeBAX802
    D.3.9.3Other descriptive nameSUSOCTOCOG ALFA
    D.3.9.4EV Substance CodeSUB166390
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hemophilia A with anti factor VIII
    Emofilia A congenita con inibitori all’FVIII
    E.1.1.1Medical condition in easily understood language
    Hemophilia A with anti factor VIII
    Emofilia A congenita con inibitori all’FVIII
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the perioperative hemostatic efficacy of BAX 802 in male subjects with CHA with inhibitors to human factor VIII (hFVIII) undergoing major or minor elective surgical, dental, or other invasive procedures as determined by the Global Hemostatic Efficacy Assessment (GHEA) score.
    Valutare l’efficacia emostatica peri-operatoria di BAX 802 in soggetti di sesso maschile affetti da CHA con inibitori al fattore VIII umano (human factor VIII, hFVIII) sottoposti a procedure chirurgiche elettive, dentali o ad altre procedure invasive di entità maggiore o minore, in base al punteggio basato sulla Valutazione globale dell’efficacia emostatica (Global Hemostatic Efficacy Assessment, GHEA).
    E.2.2Secondary objectives of the trial
    1. To determine the safety of BAX 802 used in the perioperative setting
    2. To determine the intra- and postoperative and overall perioperative blood loss at the end of surgery, compared to the estimated volume of expected average and maximum blood loss in a comparable healthy individual as predicted preoperatively by the investigator/surgeon
    3. To determine the daily and total weight-adjusted administration of BAX 802 per subject
    4. To determine the blood product utilization
    5. To determine the occurrence of bleeding episodes during the intra- and postoperative periods and additional need for surgical intervention
    6. To evaluate any unrelated bleeding episodes in the postoperative period.
    1. Determinare la sicurezza di BAX 802 utilizzato in ambito peri-operatorio
    2. Determinare la perdita di sangue intra- e post-operatoria e quella peri-operatoria complessiva al termine dell’intervento chirurgico, rispetto al volume stimato della perdita di sangue media e massima stimata in un individuo sano di confronto in base a quanto previsto in fase pre-operatoria dallo sperimentatore/dal chirurgo
    3. Determinare la somministrazione quotidiana e totale ponderata di BAX 802 per soggetto
    4. Determinare l’utilizzo degli emoderivati
    5. Determinare la comparsa di episodi emorragici durante i periodi intra- e post-operatori e l’ulteriore necessità di ricorso all’intervento chirurgico
    6. Valutare qualsiasi episodio emorragico non correlato nel periodo post-operatorio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male and ≥ 18 to ≤ 65 years old at the time of screening
    2. Subject has provided signed informed consent
    3. Subject has severe (FVIII level < 1%) or moderately severe (FVIII level ≤ 2%) CHA with inhibitors
    to human FVIII, as tested at screening at the central laboratory
    4. Subject requires elective surgery or other invasive procedures
    5. Subject is not currently receiving or has recently received (< 30 days) ITI therapy
    6. Subject has a Karnofsky performance score of ≥ 60
    7. Subject is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and
    CD4+ count ≥ 200 cells/mm3 at screening
    8. Subject is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing;
    or HCV+ with chronic stable hepatitis disease
    9. Subject is willing and able to comply with the requirements of the protocol.
    1. Il soggetto è maschio e di età compresa fra 18 e 65 anni al momento dello screening.
    2. Il soggetto ha fornito un consenso informato firmato.
    3. Il soggetto presenta CHA grave (livello FVIII < 1%) o moderatamente grave (livello FVIII ≤ 2%) con inibitori all’FVIII umano, come verificato allo screening presso il laboratorio centrale.
    4. Il soggetto richiede intervento chirurgico elettivo o altre procedure invasive.
    5. Il soggetto non sta attualmente ricevendo o ha ricevuto di recente (< 30 giorni) terapia di induzione dell’immunotolleranza (immune tolerance induction, ITI).
    6. Il soggetto presenta uno stato prestazionale di Karnofsky ≥ 60.
    7. Il soggetto è negativo al virus dell’immunodeficienza umana (HIV-) o è HIV+ con malattia stabile e conta CD4+ ≥ 200 cellule/mm3 allo screening.
    8. Il soggetto è negativo al virus dell’epatite C (HCV-) in base al test anticorpale o della reazione a catena della polimerasi (polymerase chain reaction, PCR) o è HCV+ con epatite cronica stabile.
    9. Il soggetto intende ed è in grado di attenersi ai requisiti previsti dal protocollo.
    E.4Principal exclusion criteria
    1. The subject requires emergency surgery
    2. The subject’s weight is < 35 kg or > 120 kg
    3. Clinically symptomatic liver disease (eg, ≥ 5 X upper limit of normal alanine aminotransferase
    [ALT], as confirmed by central laboratory at screening, clinical evidence of portal hypertension,
    severe hypoalbuminemia or a documented prothrombin time/international normalized ratio [PT/INR]
    > 1.5)
    4. Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dL), as confirmed by central
    laboratory at screening
    5. Anti-porcine inhibitor > 10 Bethesda units (BU) prior to surgery
    6. Platelet count < 100,000/μL
    7. Subject has another active coagulation disorder, other than hemophilia A, as per the medical history
    8. Planned use of α-interferon with or without ribavarin for HCV infected patients or planned use of a
    protease inhibitor for HIV-infected patients. Patients currently taking any of these medications for
    ≥ 30 days are eligible
    9. Known hypersensitivity to rpFVIII, or hamster or murine proteins
    10. Subject has been exposed to an IP within 30 days prior to enrollment or is scheduled to participate in
    another clinical study involving an IP or investigational device during the course of this study
    11. Unable to tolerate quantity of blood to be drawn for protocol procedures
    12. Subject is a family member or employee of the investigator
    1. Il soggetto necessita di intervento chirurgico urgente.
    2. Il peso del soggetto è < 35 kg o > 120 kg.
    3. Epatopatia clinicamente sintomatica (ad es. alanina aminotransferasi [ALT] ≥ 5 X il limite superiore della norma, in base ai valori confermati dal laboratorio centrale allo screening, evidenza clinica di ipertensione portale, grave ipoalbuminemia o tempo di protrombina documentato/rapporto internazionale normalizzato [prothrombin time, PT/international normalized ratio, INR] > 1,5).
    4. Malattia renale clinicamente sintomatica (creatinina sierica > 2,0 mg/dl), in base ai valori confermati dal laboratorio centrale allo screening.
    5. Inibitore anti-suino > 10 unità Bethesda (Bethesda units, BU) prima dell’intervento chirurgico.
    6. Conta piastrinica < 100.000/μl.
    7. Il soggetto presenta un’altra patologia della coagulazione attiva, diversa dall’emofilia A, in base alla sua anamnesi medica.
    8. Uso programmato di interferone α con o senza ribavarina per i pazienti con HCV oppure uso programmato di un inibitore della proteasi per pazienti con HIV. I pazienti che attualmente assumono uno qualsiasi di questi farmaci per ≥ 30 giorni sono idonei.
    9. Ipersensibilità nota all’rpFVIII o alle proteine di criceto o murine.
    10. Il soggetto è stato esposto ad un IP nei 30 giorni precedenti l’arruolamento oppure è previsto che il soggetto partecipi a un altro studio clinico con un prodotto o un dispositivo sperimentale nel corso di questo studio.
    11. Non in grado di tollerare la quantità di sangue prelevato prevista dalle procedure del protocollo.
    12. Il soggetto è un familiare o un dipendente dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the GHEA score, which is composed of 3 individual ratings:
    • Assessment of intraoperative hemostatic efficacy of BAX 802 performed by the operating surgeon
    • Assessment of postoperative hemostatic efficacy of BAX 802 at postoperative Day 1 (approximately 24 hours after surgery) performed by the operating surgeon
    • Assessment of overall perioperative hemostatic efficacy of BAX 802 at Day 14 or discharge (whichever is earlier), performed by the investigator.
    The scores of each of the 3 individual ratings described above, will be added together to form a GHEA score.
    La misura di esito primaria è il punteggio GHEA, che è composto da 3 singole valutazioni:
    • Valutazione dell’efficacia emostatica intra-operatoria di BAX 802 effettuata dal chirurgo che compie l’operazione
    • Valutazione dell’efficacia emostatica post-operatoria di BAX 802 il Giorno 1 post-operatorio (circa 24 ore dopo l’intervento chirurgico) effettuata dal chirurgo che compie l’operazione
    • Valutazione dell’efficacia emostatica peri-operatoria globale di BAX 802 il Giorno 14 o alla dimissione (a seconda dell’evento che si verifica prima), effettuata dallo sperimentatore
    I punteggi di ognuna delle 3 singole valutazioni sopra descritte saranno sommati per formare un punteggio GHEA unico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Varying times as defined by the protocol
    Diverse volte come definito dal protocollo
    E.5.2Secondary end point(s)
    Efficacy
    1. Blood loss compared to the estimated volume of expected average
    blood loss and expected maximum blood loss in a comparable healthy
    individual as predicted preoperatively by the investigator/surgeon at the
    following time points:
    • Intraoperative, at the end of surgery
    • Postoperative Day 1, approximately 24 hours after surgery
    • Overall perioperative Day 14 or discharge (whichever is earlier)
    2. Daily and total weight-adjusted administration of BAX 802 per subject
    3. Volume of blood, red blood cells, platelets, and other blood products
    transfused
    4. Occurrence of bleeding episodes during the intra- and postoperative
    periods and additional need for surgical intervention
    5. Efficacy of the treatment of unrelated bleeding episodes in the
    postoperative period.
    Safety
    1. Development of, and changes to, the titer of inhibitory and binding
    antibodies to rpFVIII
    2. Development of, and changes to, the titer of inhibitory and binding
    antibodies to hFVIII
    3. Development of binding antibodies to BHK proteins
    4. Occurrence of thrombotic events
    5. Incidence of severe allergic reactions (eg, anaphylaxis)
    6. Incidence of other IP-related AEs
    7. Incidence of clinically significant changes in vital signs and routine
    laboratory parameters (hematology, clinical chemistry)
    Efficacia
    1. Perdita di sangue rispetto al volume stimato della perdita di sangue media prevista e della perdita di sangue massima prevista in un individuo sano di confronto in base a quanto previsto in fase pre-operatoria dallo sperimentatore/dal chirurgo ai seguenti punti temporali:
    • Fase intraoperatoria, al termine dell’intervento chirurgico
    • Fase postoperatoria al Giorno 1, circa 24 ore dopo l’intervento chirurgico
    • Fase perioperatoria globale al Giorno 14 o alla dimissione (a seconda dell’evento che si verifica prima)
    2. Somministrazione quotidiana e totale ponderata di BAX 802 per soggetto
    3. Volume di sangue, globuli rossi, piastrine e altri emoderivati trasfusi
    4. Comparsa di episodi emorragici durante i periodi intra- e post-operatori e l’ulteriore necessità di ricorso all’intervento chirurgico
    5. Efficacia del trattamento degli episodi emorragici non correlati nel periodo post-operatorio
    Sicurezza
    1. Sviluppo e variazione della titolazione di anticorpi inibitori e leganti al fattore VIII suino ricombinante (recombinant porcine factor VIII, rpFVIII)
    2. Sviluppo e variazione della titolazione di anticorpi inibitori e leganti all’hFVIII
    3. Sviluppo di anticorpi leganti alle proteine BHK
    4. Comparsa di eventi trombotici
    5. Incidenza delle reazioni allergiche gravi (ad es. anafilassi)
    6. Incidenza di altri AE correlati all’IP
    7. Incidenza di variazioni clinicamente significative dei segni vitali e dei parametri di laboratorio di routine (ematologia, chimica clinica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varying times as defined by the protocol.
    Tempistiche variabili come definite dal Protocollo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    France
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 14
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 14
    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)
    Normal treatment to be continued as discussed with the subject's doctor
    Deve essere continuato il trattamento consueto come discusso con il medico del paziente
    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 Decision2016-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-11
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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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