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    Summary
    EudraCT Number:2017-003324-67
    Sponsor's Protocol Code Number:BAY1093884/19580
    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:2019-08-13
    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 number2017-003324-67
    A.3Full title of the trial
    Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors
    Studio di dosi multiple crescenti di BAY1093884 in adulti affetti da emoflia A o B con o senza inibitori
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors
    Studio con multiple dosi crescenti di BAY1093884 in adulti affetti da emoflia A o B con o senza inibitori
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    n.a.
    A.4.1Sponsor's protocol code numberBAY1093884/19580
    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 AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ cityBerlino
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number004930300139003
    B.5.5Fax number004930300139003
    B.5.6E-mailclinical-trials-contact@bayer.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/3/18/1979
    D.3 Description of the IMP
    D.3.1Product nameanti-TFPI (Tissue Factor Pathway Inhibitor) antibody
    D.3.2Product code BAY1093884
    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 codeBAY1093884
    D.3.9.3Other descriptive nameBAY1093884
    D.3.9.4EV Substance CodeSUB177169
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 or B
    Emofilia A o B
    E.1.1.1Medical condition in easily understood language
    Hemophilia A and B are genetically inherited bleeding disorders caused by the deficiency of Factor VIII (FVIII) or Factor IX (FIX), respectively.
    Emofilia A e B sono condizioni emorragiche ereditarie caratterizzate dalla carenza di uno specifico fattore della coagulazione rispettivamente del Fattore VIII(Emofilia A) o del Fattore IX(Emofilia B)
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10053754
    E.1.2Term Hemophilia B without inhibitors
    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 10053753
    E.1.2Term Hemophilia A without inhibitors
    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 assess the safety and tolerability of multiple subcutaneous doses of BAY 1093884 in subjects with hemophilia A or B with or without inhibitors.
    Valutare la sicurezza e la tollerabilità di dosi sottocutanee multiple di BAY 1093884 in pazienti affetti da emofilia A o B con o senza inibitori.
    E.2.2Secondary objectives of the trial
    There are no secondary objectives in the trial.
    Nello studio non sono presenti obiettivi secondari
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The PK sub-study is fully integrated within the study protocol with no separate title.
    Short description: Blood samples in at least 2 subjects per dose cohort will be drawn for PK analyses of BAY 1093884. These samples will be
    collected at the following time points: pre-dose, 4h, 24h, 96h, 168h after administration of BAY 1093884, both at week 0 and week 11. It is an optional sub-study for subjects, and separate consent will be requested from the subjects.
    Il sottostudio di farmacocinetica è interamente integrato nel protocollo di studio senza un titolo a parte.
    Breve descrizione: per l'analisi di farmacocinetica di BAY 1093884 verranno prelevati i campioni di sangue in almeno 2 soggetti per coorte di dose. Questi campioni saranno raccolti ai seguenti time point: pre-dose, 4h, 24h, 96h, 168h, dopo la somministrazione di BAY 1093884, sia alla settimana 0 che alla settimana 11. E' un sottostudio opzionale per i soggetti i che dovranno firmare un consenso a parte.
    E.3Principal inclusion criteria
    1. Male subjects with hemophilia A or hemophilia B (any severity) with inhibitors against FVIII or FIX (any inhibitor titer).
    2. Male subjects with severe hemophilia A (FVIII activity <1%) or B (FIX activity <2%) without inhibitors.
    3. Subjects with a past history of inhibitors (any inhibitor titer) are eligible.
    4. Age ≥18 years.
    5. Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not) within the 6 months prior to screening.
    6. For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.
    7. For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing ITI.
    8. Signed informed consent.
    1. Pazienti di sesso maschile affetti da emofilia A o B (di qualsiasi gravità) con inibitori contro il FVIII o il FIX (qualsiasi titolo di inibitore).
    2. Pazienti di sesso maschile affetti da emofilia A (attività del FVIII < 1%) o B (attività del FIX < 2%) grave senza inibitori.
    3. I pazienti con pregresso inibitore (qualsiasi titolo di inibitore) sono eleggibili.
    4. Età ≥18 anni.
    5. Documentazione di ≥4 episodi di sanguinamento (qualsiasi tipo o sede dell'emorragia, trattata o meno) nei 6 mesi precedenti allo screening.
    6. Per i pazienti sottoposti a profilassi: disponibilità a interrompere la profilassi in corso.
    7. Per i pazienti sottoposti a induzione dell’immunotolleranza (ITI): disponibilità a interrompere l'ITI in corso.
    8. Firma del consenso informato.
    E.4Principal exclusion criteria
    1. History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder.
    2. History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or
    thrombotic microangiopathy.
    3. Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes).
    4. History of cardiac, coronary and/or arterial peripheral atherosclerotic disease, particularly myocardial infarction, cerebrovascular accident,
    stroke, transient ischemic attack, congestive heart failure, angina pectoris or treatment for angina pectoris.
    5. Platelet count <100,000/μL.
    6. Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 (CD4+) lymphocyte count of <200/mm3.
    7. Any planned major surgical intervention.
    8. Subjects with known or suspected hypersensitivity to trial product(s) or related products.
    9. Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
    10. Subjects with advanced liver disease (signs of liver function impairment, e.g., albumin, vitamin K coagulation factors) and/or alanine
    aminotransferase (ALT) and aspartate aminotransferase (AST) levels >3
    times the upper limit of the normal range and/or total bilirubin >2.0 times the upper limit of the normal range.
    11. Subjects with serum creatinine >2.0 times the upper limit of the normal range.
    12. Participation in a study with an investigational drug within 3 months prior to enrolment.
    13. Subjects not willing to stop prophylaxis or ITI.
    1. Anamnesi di qualsiasi altro disturbo della coagulazione (in particolare coagulopatia intravascolare disseminata o carenza combinata di FVIII/FV) o difetto piastrinico.
    2. Storia di patologie associate a eventi tromboembolici venosi (ad esempio embolia polmonare, trombosi venosa profonda,
    tromboflebite) o microangiopatia trombotica.
    3. Presenza di fattori di rischio per patologie venose o arteriose (ad esempio ipertensione non controllata, diabete non controllato).
    4. Storia di aterosclerosi cardiaca, coronarica e/o delle arterie periferiche, in particolare infarto del miocardio, accidente cerebrovascolare, ictus, attacco ischemico transitorio, insufficienza cardiaca congestizia, angina pectoris o trattamento per l'angina pectoris.
    5. Conta piastrinica <100.000/μL.
    6. Infezione da virus dell’immunodeficienza umana (HIV) con conta dei linfociti CD4+ <200/mm3.
    7. Qualsiasi intervento di chirurgia maggiore pianificato.
    8. Pazienti con ipersensibilità nota o sospetta al/i prodotto/i sperimentale/i o a prodotti correlati.
    9. Pazienti affetti da una malattia autoimmune nota o in trattamento con immunomodulatori.
    10. Pazienti affetti da epatopatia in stadio avanzato (segni di compromissione della funzionalità epatica, ad esempio riduzione dei livelli di albumina e/o dei fattori della coagulazione dipendenti dalla vitamina K) e/o livelli di alanina aminotransferasi (ALT) e aspartato aminotransferasi
    (AST) > 3 volte il limite superiore dell’intervallo di
    normalità e/o bilirubina totale > 2,0 volte il limite superiore dell’intervallo di normalità.
    11. Pazienti con creatinina sierica > 2,0 volte il limite superiore dell’intervallo di normalità.
    12. Partecipazione a uno studio condotto su un farmaco sperimentale nei 3 mesi antecedenti all’arruolamento.
    13. Pazienti non disposti a interrompere la profilassi o l'ITI.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is safety as defined by the frequency of drugrelated AEs, SAEs, AESIs, ISRs and clinically relevant abnormal laboratory values.
    Another safety endpoint will be the frequency of binding and neutralizing antibodies against BAY 1093884.
    L'endppint primario è la sicurezza definita dalla Frequenza di AE correlati al farmaco, eventi avversi gravi (SAE), eventi avversi di interesse specifico (AESI), reazioni nella sede di iniezione (ISR) e alterazioni clinicamente rilevanti nei test di laboratorio. Un altro endpoint di sicurezza sarà la frequenza di legame e di neutralizzazione degli anticorpi contro il BAY 1093884
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the conduct of the study
    Nel corso dello studio, inclusa la parte di estensione, tutti i pazienti saranno monitorati attentamente per quanto riguarda la sicurezza
    E.5.2Secondary end point(s)
    There is no secondary endpoint
    endpoint secondario non presente
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    n/a
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    Arruolamento progressivo in differenti coorti di dose
    Sequential enrollment into different dose cohorts.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Austria
    Bulgaria
    France
    Hungary
    Italy
    Japan
    Korea, Republic of
    New Zealand
    South Africa
    Taiwan
    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
    Part A and Part B of the study includes 24 weeks per subject. The date when the last subject in Cohort 3 has completed 24 weeks of treatment
    will be the primary completion date. After the primary completion date, all subjects will either remain on the current dose for long-term safety
    evaluation or will escalate to the next higher opened dose, if dose escalation criteria are fulfilled.
    Ciascun paziente sarà trattato con la dose assegnata di BAY 1093884 (X mg, Y mg o Z mg) per 12 settimane. Ciascun paziente sarà trattato per altre 12 settimane. La data in cui l'ultimo paziente della Coorte 3 (dose Z) completerà la Parte B rappresenterà la data di cut-off del database, ossia la data di conclusione primaria. Una volta completata la Parte B, tutti i pazienti saranno invitati a proseguire il trattamento in una parte di estensione. Durante la fase di estensione, tutti i pazienti
    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 months5
    E.8.9.1In the Member State concerned days15
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 24
    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 from the current trial will be offered continued treatment, until time of Marketing Authorization.
    Parte A di 12 settimane seguita dalla Parte B di altre 12 settimane, trascorsa la quale tutti i pazienti proseguiranno il trattamento in una parte di estensione, che potrebbe protrarsi fino all'Autorizzazione all’immissione in commercio.
    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 Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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