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    Summary
    EudraCT Number:2021-004858-30
    Sponsor's Protocol Code Number:BAY94-9027/21824
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-07-06
    Trial 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 number2021-004858-30
    A.3Full title of the trial
    A phase 3, single group treatment, open-label, study to evaluate the safety of BAY 94-9027 infusions for prophylaxis and treatment of bleeding in previously treated children aged 7 to <12 years with severe hemophilia A
    Studio in aperto, a singolo braccio, di fase 3 per valutare la sicurezza delle infusioni di BAY 94-9027 per la profilassi e il trattamento delle emorragie in pazienti pediatrici di età compresa tra 7 e meno di 12 anni affetti da emofilia A severa precedentemente trattati.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 safety study of BAY 94-9027 in children 7 to <12 years of age with severe hemophilia A
    Studio di fase 3 sulla sicurezza di BAY 94-9027 in pazienti pediatrici di età compresa tra 7 e meno di 12 anni affetti da emofilia A severa
    A.4.1Sponsor's protocol code numberBAY94-9027/21824
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05147662
    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 Consumer Care AG
    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 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 AddressN/A
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Jivi
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameJivi (500 IU)
    D.3.2Product code BAY 94-9027
    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 INNDamoctocog alfa pegol
    D.3.9.2Current sponsor codeBAY 94-9027
    D.3.9.3Other descriptive namePEGylated B-domain deleted recombinant human antihemophilic Factor VIII
    D.3.9.4EV Substance CodeSUB187618
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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 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 Jivi
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameJivi (1000 IU)
    D.3.2Product code BAY 94-9027
    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 INNDamoctocog alfa pegol
    D.3.9.3Other descriptive namePEGylated B-domain deleted recombinant human antihemophilic Factor VII
    D.3.9.4EV Substance CodeSUB187618
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    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
    Severe hemophilia A (<1% FVIII:C)
    Emofilia A severa (<1% FVIII:C)
    E.1.1.1Medical condition in easily understood language
    Hemophilia A is an X-linked congenital bleeding disorder causing frequent bleedings and recurrent spontaneous bleeds into the soft tissue and joints, leading to joint damage and severe disability.
    L'Emofilia A è una malattia emorragica congenita X-linked che provoca emorragie frequenti e sanguinamenti ricorrenti spontanei nei tessuti molli e nelle articolazioni, con conseguenti danni alle artic
    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 10060612
    E.1.2Term Hemophilia A
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    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 BAY94-9027 replacement therapy in previously treated patients 7 to < 12 years of age with severe hemophilia A
    Valutare la sicurezza e la tollerabilità della terapia sostitutiva a base di BAY 94-9027 in pazienti di età compresa tra 7 e meno di 12 anni affetti da emofilia A severa precedentemente trattati
    E.2.2Secondary objectives of the trial
    To describe the clinical efficacy of BAY94-9027
    Descrivere l’efficacia clinica di BAY 94-9027
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be 7 to <12 years of age at the time of parent / guardian signing the informed consent.
    2. Participants with known medical history of severe hemophilia A (participant’s own FVIII activity [FVIII:C] <1%. FVIII:C) based on reliable prior documentation in clinical records of the participants. If no reliable documentation is available, FVIII activity must be measured at the time of screening after a 48-72 hours wash-out period (depending on his previous product).
    3. Male
    4. Participants must be previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 50 exposure days (EDs) at the time of signing the informed consent.
    5. Participant has understood the study and if appropriate for his age, has signed an informed assent. The parent(s) or guardian(s) is capable of giving signed informed consent and are able to comply with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
    6. Willingness and ability of participants and/or parents /caregivers to complete training in the use of the electronic patient diary (EPD) and to document infusions during the study.
    Età
    1. I partecipanti devono avere un’età compresa tra 7 e meno di 12 anni al momento della firma del consenso informato da parte del genitore/tutore legale
    Tipo di partecipante e caratteristiche della malattia
    2. Partecipanti con anamnesi clinica nota di emofilia A severa (attività del FVIII del partecipante[FVIII:C] <1%. FVIII:C) sulla base di una documentazione attendibile precedente presente nelle cartelle cliniche dei partecipanti. In assenza di documenti attendibili, l’attività del FVIII deve essere misurata allo screening dopo un periodo di wash-out di 48-72 ore (a seconda del prodotto assunto in precedenza).
    Sesso
    3. Maschile
    Trattamento
    4. I partecipanti devono essere stati trattati in precedenza con uno o più concentrati di FVIII (plasmaderivati o ricombinanti) per almeno 50 giorni di esposizione (ED) al momento della firma del consenso informato.
    Consenso e assenso informato
    5. Il partecipante ha compreso lo studio e, laddove applicabile in base alla sua età, ha firmato un assenso informato. Il/i genitore/i o il/i tutore/i è/sono in grado di fornire il consenso informato firmato che comprende l’aderenza ai requisiti e ai limiti riportati nel modulo di consenso informato (ICF) e nel presente protocollo.
    6. I partecipanti e/o i genitori/caregiver devono essere disponibili a e in grado di completare la formazione sull’uso del Diario elettronico del paziente (EPD) e documentare le infusioni eseguite durante lo studio.

    E.4Principal exclusion criteria
    1. History of FVIII inhibitors. Inhibitor to FVIII is defined as a titer >0.6 BU/mL or clinical history suggestive of inhibitor requiring modification of treatment. Participants with a maximum historical titer of <1.0 BU on no more than 1 occasion with the classical Bethesda assay but at least 3 subsequent negative results [<0.6 BU] are eligible.
    2. Current evidence of inhibitor to FVIII measured using the Nijmegen modified Bethesda assay (>0.6 BU/mL) at the time of screening (central laboratory). Participants should not receive FVIII within 48 h prior to the collection of screening samples and should have FVIII administered within the prior 2-3 weeks
    3. Any other inherited or acquired bleeding disorder in addition to hemophilia A (e.g., von Willebrand disease, hemophilia B)
    4. Platelet count <100,000 cells/µL
    5. Serum creatinine > 2x upper limit of normal
    6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5x upper limit of normal
    7. Known hypersensitivity or allergic reaction to drug substance, excipients or mouse or hamster protein
    8. Any other significant medical condition that the investigator feels would be a risk to the participant or would impede the study
    9. Requires any pre-medication to tolerate FVIII treatment (e.g. antihistamines)
    10. Planned major surgery during the study
    11. Any individual who is currently receiving or received chemotherapy, immune modulatory drugs other than anti-retroviral chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids (> 14 days) within the last 3 months
    12. Any individual who received commercially available subcutaneous factor substitution therapy (emicizumab) within the last 6 months
    13. The participant is currently participating in another investigational drug study or has participated in a clinical study involving an investigational drug within 30 days of study entry or previous participation in a clinical study with BAY 94-9027.
    Condizioni cliniche
    1. Storia clinica di inibitori contro il FVIII. Gli inibitori contro il FVIII sono definiti come un titolo >0,6 BU/ml (variazione di Nijmegen del saggio Bethesda) o come un’anamnesi clinica che suggerisce lo sviluppo di inibitori che richiedono una modifica del trattamento. Sono idonei i partecipanti con un titolo storico massimo <1,0 BU/ml in non più di un’occasione con il saggio Bethesda classico e con almeno 3 risultati negativi successivi [<0,6 BU/ml].
    2. Attuale evidenza di inibitori contro il FVIII misurati utilizzando la variazione di Nijmegen del saggio Bethesda (>0,6 BU/ml) al momento dello screening (laboratorio centrale). I partecipanti non devono ricevere FVIII almeno nelle 48 ore precedenti la raccolta dei campioni di screening e devono aver ricevuto una somministrazione di FVIII nelle 2-3 settimane precedenti
    3. Qualsiasi altro disturbo emorragico ereditario o acquisito che si aggiunge all’emofilia A (ad es. malattia di von Willebrand, emofilia B)
    4. Conta piastrinica <100.000 cellule/µl
    5. Creatinina sierica >2 volte il limite superiore alla norma
    6. Aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) >5 volte il limite superiore alla norma
    7. Reazione allergica o ipersensibilità nota alla sostanza farmacologica, agli eccipienti o alle proteine di topo o di criceto
    8. Qualsiasi altra condizione clinica significativa che, a discrezione dello sperimentatore, costituisca un rischio per il partecipante o possa ostacolare lo svolgimento dello studio
    Terapie precedenti/concomitanti
    9. Necessità di premedicazione per tollerare il trattamento con FVIII (ad es. antistaminici)
    10. Intervento di chirurgia maggiore pianificato durante lo studio
    11. Chiunque stia attualmente ricevendo o abbia ricevuto una chemioterapia o immunomodulatori o che faccia/abbia fatto uso cronico di corticosteroidi per via orale o endovenosa (EV) (>14 giorni) negli ultimi 3 mesi, terapie antivirali escluse
    12. Chiunque abbia ricevuto una terapia sostitutiva a base di fattore per via sottocutanea disponibile in commercio (emicizumab) negli ultimi 6 mesi
    Esperienza di studi clinici precedenti/concomitanti
    13. Il partecipante sta attualmente partecipando a un altro studio su un farmaco sperimentale o ha partecipato a uno studio clinico su un farmaco sperimentale nei 30 giorni precedenti l’ingresso nello studio oppure in passato ha partecipato a uno studio clinico su BAY 94-9027.
    Altre esclusioni
    14. Stretta relazione con la sede della sperimentazione, ad es. parenti stretti dello sperimentatore, dipendenti
    15. Vulnerabilità diversa dall’età pediatrica
    16. Lo sperimentatore identifica il partecipante come non in grado o non disposto a eseguire le procedure dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    • AESI (hypersensitivity and LODE*) associated with the first 4 EDs leading to discontinuation
    AESI (ipersensibilità e LoE) associati ai primi 4 ED che hanno portato alla sospensione del trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    AESI within the first 4 exposure (dose) days; the first two weeks
    AESI entro i primi 4 giorni di esposizione (dosi); le prime 2 settimane
    E.5.2Secondary end point(s)
    Secondary endpoints
    • Adverse drug reactions (ADRs)
    • Anti-drug antibody (ADA) development
    • Inhibitor development
    • Annualized bleeding rate (ABR)
    • BAY 94-9027 consumption
    • Number of infusions/month and year (Annualized Infusion Rate)
    • Reazioni avverse al farmaco (ADR)
    • Sviluppo di anticorpi anti-farmaco (ADA)
    • Sviluppo di inibitori
    • Percentuale annualizzata di emorragie (ABR)
    • Consumo di BAY 94-9027
    • Numero di infusioni/mese e anno (tasso di infusione annualizzato)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints from time of first dose to last study visit
    Per tutti gli endpoint secondari dal tempo della prima dose all’ultima visita di 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 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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Brazil
    Canada
    United States
    Italy
    Norway
    Turkey
    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
    The end of the trial is the last visit (follow-up call 2 weeks after end of treatment) of the last subject undergoing study treatment
    Ultima visita (contatto telefonico di follow-up 2 settimane dopo fine trattamento) dell’ultimo paziente che ha ricevuto il trattamento
    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 months6
    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.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors below 12 years of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 40
    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 of condition
    terapia standard
    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 Decision2022-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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