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    Summary
    EudraCT Number:2011-000323-33
    Sponsor's Protocol Code Number:BAY86-6150,IMPACT15534
    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:2013-06-05
    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 number2011-000323-33
    A.3Full title of the trial
    A Phase 2/3, multicenter, open-label clinical study to assess the safety and efficacy of BAY86-6150 in subjects with hemophilia A or B with inhibitors, composed of 2 Parts (A & B). Part A: Sequential cohorts of four dose levels of the modified rFVIIa BAY 86-6150 assessed in a non-controlled dose response design in acutely bleeding subjects and for PK/ PD in an intra-individual crossover design compared with one fixed dose of eptacog alfa (activated) in non-bleeding subjects. Part B: Confirmatory study to further investigate the efficacy and safety of BAY 86-6150.
    Studio multicentrico, in aperto, di fase II/III, in 2 parti (A e B), di valutazione della sicurezza e dell’efficacia di BY 86-6150, in soggetti affetti da emofilia A o B con inibitori.
    Parte A: studio su 4 diversi dosaggi di rFVIIa modificato, BAY 86-6150, valutati su 4 coorti di soggetti emofilici con inibitori in corso di sanguinamento acuto, secondo un disegno dose-risposta, senza gruppo di controllo.
    In questa parte A è previsto un ulteriore studio opzionale di farmacocinetica/farmacodinamica, con disegno in cross-over intra-individuale, di confronto con dose fissa di eptacog alfa (attivato), in soggetti emofilici con o senza inibitori, in assenza di sanguinamento attivo.
    Parte B: Studio di conferma per esaminare ulteriormente l’efficacia e la sicurezza di BAY 86-6150.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2/ 3 trial to evaluate the efficacy and safety of BAY86-6150
    Studio di Fase II/III per valutare la sicurezza e l’efficacia di BAY 86-6150
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2/ 3 trial to evaluate the efficacy and safety of BAY86-6150
    Studio di Fase II/III per valutare la sicurezza e l’efficacia di BAY 86-6150
    A.4.1Sponsor's protocol code numberBAY86-6150,IMPACT15534
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointCTP Team / Ref: "EU CTR" / S102 - R
    B.5.3 Address:
    B.5.3.1Street AddressMüllerstr. 170-178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code D-13353
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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/3/09/675 (Hem A) & EU/3/09/676 (Hem B)
    D.3 Description of the IMP
    D.3.1Product nameBAY 86-6150
    D.3.2Product code BAY 86-6150, modified recombinant human Factor VII
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBAY 86-6150
    D.3.9.3Other descriptive namemodified recombinant human Factor VIIa
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 NovoSeven
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameNovoSeven
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPTACOG ALFA (ACTIVATED)
    D.3.9.1CAS number 102786-61-8
    D.3.9.4EV Substance CodeSUB06591MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 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
    Subjects with hemophilia A or B with inhibitors
    Soggetti affetti da emofilia A o B con inibitori.
    E.1.1.1Medical condition in easily understood language
    Subjects with hemophilia A or B with inhibitors
    Soggetti affetti da emofilia A o B con inibitori.
    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 14.1
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10053752
    E.1.2Term Hemophilia B with anti factor IX
    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
    Part A:
    - To identify the recommended dose by conducting a risk-benefit assessment of four different dose levels of BAY 86-6150 based on safety and dose response assessments in acutely bleeding subjects with hemophilia A or B with inhibitors.
    Part B:
    - To further investigate the safety and efficacy of the recommended dose of BAY 86-6150 in acutely bleeding subjects with hemophilia A or B with inhibitors.
    Parte A:
    •Identificare la dose raccomandata attraverso una valutazione del rapporto rischio/beneficio di quattro diversi dosaggi di BAY 86-6150, sulla base di valutazioni di sicurezza e di risposta alla dose in soggetti con emorragia acuta affetti da emofilia A o B con inibitori.
    Parte B:
    •Esaminare ulteriormente la sicurezza e l’efficacia della dose raccomandata di BAY 86-6150 in soggetti con emorragia acuta affetti da emofilia A o B con inibitori.
    E.2.2Secondary objectives of the trial
    - To assess the potential immunogenicity of BAY 86-6150 in subjects with hemophilia A or B with inhibitors.
    - To evaluate the comparative PK/PD (pharmacokinetics/pharmacodynamics) parameters to one fixed dose of eptacog alfa (activated) in a subset of the above cohorts at the same four dose levels of BAY 86-6150.
    Obiettivi secondari:
    •Valutare la potenziale immunogenicità di BAY 86-6150 in soggetti affetti da emofilia A o B con inibitori.
    •Confrontare i parametri di farmacocinetica e farmacodinamica (PK/PD) delle 4 dosi di BAY 86-6150 con una dose fissa di eptacog alfa (attivato) in un ulteriore sottogruppo delle suddette coorti,
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male subjects
    - 12 to 62 years-of-age
    - History of moderate or severe congenital hemophilia A or B with inhibitors to FVIII or FIX
    - 4 or more bleeding episodes in the last 6 months before enrollment.
    Soggetti di sesso maschile tra 12 e 62 anni con anamnesi di emofilia A o B congenita moderata o grave con inibitori contro FIII o FIX che abbiano avuto 4 o più episodi emorragici negli ultimi 6 mesi prima dell'arruolamento.
    E.4Principal exclusion criteria
    - Clinically relevant coagulation disorder other than congenital hemophilia A or B with inhibitors
    - History of coronary and/or peripheral atherosclerotic disease
    - Disseminated intravascular coagulopathy, or stage 2 hypertension
    - Angina pectoris
    - Myocardial infarction
    - Transient ischemic attack
    - Stroke
    - Congestive heart failure
    - Thromboembolic event
    Disordini della coagulazione clinicamente rilevanti diversi da emofilia a o B congenite con inibitori -storia di patologia aterosclerotica coronarica e/o periferica - Coagulopatia intravascolare disseminata o ipertensione di fase 2 - angina pectoris - Infarto miocardico - Attacco ischemico transitorio - Ictus - Insufficienza cardiaca congestizia - Evento tromboembolico
    E.5 End points
    E.5.1Primary end point(s)
    1. Successful treatments of bleeding episodes. (A bleed was defined as successfully treated, if no administration of rescue medication was required.)
    2. Proportion of successful treatments of bleeding episodes on subject level. (Proportion of successful treatments of bleeding
    episodes was calculated as number of bleeding episodes treated successfully - without rescue medication - divided by the total number of bleeding episodes on a dose level.)
    L’endpoint primario è rappresentato dal successo del trattamento, definito come:
    • Livello di emorragia: nessuna somministrazione del farmaco di emergenza [vero/falso].
    • Livello soggettivo: la percentuale individuale di successo viene calcolata come il numero di episodi emorragici trattati con successo (senza farmaco di emergenza) diviso per il numero totale di episodi emorragici verificatisi con un certo livello di dose. Un responder è definito come la soggetto che ha almeno il 70% di episodi emorragici trattati senza il farmaco di emergenza.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 10 hours after each bleed
    2. 10 hours after each bleed
    1. 10 ore dopo ogni sanguinamento
    2. 10 ore dopo ogni sanguinamento
    E.5.2Secondary end point(s)
    1. Time to stop the bleed.
    2. Number of injections needed to stop the bleeding episode.
    3. Effectiveness of treatment as rated by the subject's assessment (very effective, effective, partially effective, not effective).
    4. Participant's reported outcome as assessed by Euro QoL (EQ-5D).
    5. Participant's reported outcome as assessed by Brief Pain Inventory.
    6. Participant's reported outcome as assessed by Work Productivity and Activity Impairment Questionaire.
    •Misure dell’esito riferite dal soggetto:
    - EuroQol, (EQ-5D) (Questionario Europeo sulla qualità della vita)
    - Brief Pain Inventory (BPI) (Breve inventario del dolore) e misure del dolore a singolo item (item n.° 3 e n.° 6 del BPI).
    - Work Productivity and Activity Impairment Questionnaire (WAPI) (Questionario sulla produttività lavorativa e sull’alterazione dell’attività)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1., 2. & 3.: 10 hours after each bleed
    4. & 6.: 14 days after last exposure to BAY86-6150
    5.: 7 days after last exposure to BAY86-6150
    1., 2. e 3.: 10 ore dopo ogni sanguinamento
    4. e 6.: 14 giorni dopo l'ultima esposizione a BAY86-6150
    5.: 7 giorni dopo l'ultima esposizione a BAY 86-6150
    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 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 No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    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.8.1.7.1Other trial design description
    Part A & B: non-controlled design / PK/PD: randomized, controlled, crossover design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial9
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Chile
    China
    Colombia
    Denmark
    European Union
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Poland
    Romania
    Singapore
    South Africa
    Sweden
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    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
    Last Patient Last Visit
    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 months11
    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 months11
    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: 20
    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: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For Adolescents (12-17 years)
    Adoloescenti (12-17 anni)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 65
    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)
    Subjects who completed Part B may continue in a subsequent extension study. Subjects who discontinued prematurely or completed the study and are not willing to participate in the extension study will revert to their individual routine treatment.
    I Pazienti che completeranno la Parte B potranno proseguire in uno studio di estensione. I pazienti che abbiamo interrotto prematuramente o concluso lo studio e non acconsentano a continuare torneranno al trattamento individuale di routine.
    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 Decision2013-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-04-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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