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    Summary
    EudraCT Number:2019-004480-48
    Sponsor's Protocol Code Number:20446
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-004480-48
    A.3Full title of the trial
    A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A
    Estudio prospectivo preliminar para recoger episodios hemorrágicos, infusiones de factor VIII (FVIII) y resultados reportados por los pacientes en pacientes con hemofilia A.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn more about bleeding episodes, the use of treatments containing a protein called clotting factor 8 (FVIII), and how the patients felt about their symptoms and pain, in people with hemophilia A
    Estudio para aprender más sobre los episodios hemorrágicos, el uso de tratamientos que contienen una proteína llamada factor de coagulación 8 (FVIII) y cómo se sienten los pacientes acerca de sus síntomas y dolor, en personas con hemofilia A.
    A.4.1Sponsor's protocol code number20446
    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 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 Clinical Trials
    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.5.4Telephone number4930300139003
    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.2.1.2Country 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.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    Hemofilia A
    E.1.1.1Medical condition in easily understood language
    Hemophilia A is an inborn condition where the body does not create enough of a protein called clotting factor 8 (FVIII) in the blood. Without it, the blood cannot clot properly to control bleeding.
    Hemofilia A es una condición congénita en que el cuerpo no produce suficiente proteína llamada factor de coagulación 8(FVIII) en sangre. Sin él, la sangre no puede coagularse para controlar sangrados.
    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 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
    Evaluate individual bleeding pattern and bleeding control in hemophilia A patients with clinically severe phenotype treated with FVIII products
    Evaluar el patrón hemorrágico individual y el control de las hemorragias en pacientes con hemofilia A con fenotipo clínicamente grave tratados con productos de FVIII.
    E.2.2Secondary objectives of the trial
    Collect information on patient-reported outcomes (PROs)
    Recoger información sobre los resultados reportados por los pacientes (PRO, por sus siglas en inglés).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be ≥18 years of age at the time of signing the informed consent.
    - Patients with severe hemophilia A (FVIII:C ≤1% baseline FVIII activity [FVIII:C] as determined by measurement at the time of screening or from reliable prior documentation in clinical records of the patients).
    - Male.
    - Previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 150 exposure days (ED) as documented in reliable prior clinical records of the patients.
    - On regular prophylaxis with FVIII (defined as ≥ 45 weeks/year of treatment with an adequate dose as per label ) and on stable treatment for at least 6 months as documented in reliable prior clinical records of the patients
    - Well-managed patients with at least 1 documented visit at the hemophilia treatment center in the year prior to enrollment.
    - Willing to participate in the interventional Phase 3 gene therapy study with BAY2599023.
    - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    - El participante debe tener ≥ 18 años en el momento de firmar el consentimiento informado.
    - Pacientes con hemofilia A grave (FVIII:C ≤ 1% de actividad de FVIII inicial [FVIII:C] según lo determinado por la medición realizada en la selección o por documentación previa fiable en la historia clínica de los pacientes).
    - Sexo masculino.
    - Tratados previamente con concentrado(s) de FVIII (derivado de plasma o recombinante) durante un mínimo de 150 días de exposición (DE) según documentación previa fiable en la historia clínica de los pacientes.
    - En profilaxis regular con FVIII (definida como ≥ 45 semanas/año de tratamiento con una dosis adecuada según ficha técnica ) y en tratamiento estable durante al menos 6 meses según documentación previa fiable en la historia clínica de los pacientes.
    - Pacientes bien controlados con al menos 1 visita documentada al centro de tratamiento de la hemofilia en el año previo a la inclusión.
    - Dispuestos a participar en el ensayo intervencionista de fase III de terapia génica con BAY 2599023.
    - Capaces de dar su consentimiento informado firmado, lo cual incluye el cumplimiento de los requisitos y restricciones listados en el formulario de consentimiento informado (FCI) y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply. Exclusion criteria marked with an asterisk (*) will lead to exclusion of the participant from the subsequent Phase 3 study, if occurring at any time during the lead-in study. If the criteria marked with an asterisk are met during the study, the participant will withdraw from the study.

    Medical Conditions:
    - *Current inhibitor to FVIII with a titer ≥ 0.6 BU, confirmed by more than 1 test.
    - History of inhibitor with a titer >1.0 BU (as documented in reliable prior clinical records of the patients) or with a repeated titer 0.6 to <1.0 BU in more than one subsequent occasion.
    - *Significant underlying liver disease, as evidenced by any of the following: portal hypertension, splenomegaly, ascites, esophageal varices, hepatic encephalopathy,
    reduction below normal limits of serum albumin or an advanced liver disease (Child-Pugh Grade B and C), suspicion of liver malignancy or fibrosis by ultrasound / Fibroscan.
    - Any of the following:
    -- Hemoglobin <11 g/dL
    -- Platelets <100,000 cells/µL
    -- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5× ULN
    -- Alkaline phosphatase (AP) >2.5 × ULN
    -- Total bilirubin >1.5 × ULN
    -- Prothrombin time (PT) or international normalized ratio (INR) >1.0 × ULN
    -- Creatinine >1.5 mg/dL
    - Another bleeding disorder that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B)
    - *Active hepatitis B or C infection, as reflected by HBsAg or HCV-RNA viral load positivity
    - Serological evidence of active HIV-1 or HIV-2 as measured by CD4+ cell count <200 cells/mm3 and/or viral load >50 gc/mL.
    - *Pre-existing immunity against AAVhu37.
    - *Any current diagnosis of malignancy.
    - Known or suspected autoimmune diseases requiring immunosuppressive therapy.
    - Body mass index > 35 kg/m^2.
    - Contraindication for corticosteroid treatment.
    - *Any other significant medical condition that would be a risk to the patient or would affect patient’s ability to receive gene transfer following completion of his participation in this lead-in study.

    Prior/Concomitant Therapy
    Listed therapies/medications are not allowed at enrollment, during the study and will also not allow transition to the Phase 3 study if introduced during the lead-in study:
    - Antiviral therapy for hepatitis B or C ,
    - Pre-medication to tolerate FVIII treatment,
    - Immunomodulatory drugs (other than corticosteroids),
    - Efavirenz,
    - Emicizumab,
    - Planned major surgery.

    Prior/Concurrent Clinical Study Experience
    - Participation in any investigational hemophilia product study within 3 months before screening (participation in any other investigational product study will not be allowed throughout the study).
    - Has received the same or another gene therapy product.
    Los participantes quedarán excluidos del estudio si se cumple alguno de los criterios siguientes. Los criterios de exclusión marcados con un asterisco (*) conducirán a la exclusión del participante del ensayo de fase III posterior, si se producen en cualquier momento durante este estudio preliminar. Si los criterios marcados con un asterisco se cumplen durante el estudio, el participante será retirado del estudio.

    Condiciones médicas:
    - *Inhibidor actual del FVIII con un título ≥ 0,6 UB, confirmado por más de 1 determinación.
    - Antecedentes de inhibidor con un título > 1,0 UB (según documentación previa fiable en la historia clínica de los pacientes) o con un título recurrente de 0,6 a <1,0 UB en más de una ocasión consecutiva.
    - *Enfermedad hepática subyacente significativa, evidenciada por cualquiera de los siguientes signos: hipertensión portal, esplenomegalia, ascitis, varices esofágicas, encefalopatía hepática, reducción de la albúmina sérica por debajo de los límites normales o enfermedad hepática avanzada (Child-Pugh de grado B y C), sospecha de neoplasia maligna hepática o fibrosis por ecografía/Fibroscan.
    - Cualquiera de los siguientes valores:
    • Hemoglobina < 11 g/dL
    • Plaquetas < 100.000 células/µL
    • Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 1,5 × LSN
    • Fosfatasa alcalina (FA) > 2,5 × LSN
    • Bilirrubina total > 1,5 × LSN
    • Tiempo de protrombina (TP) o ratio normalizado internacional (INR) > 1,0 × LSN
    • Creatinina > 1,5 mg/dL
    - Otro trastorno hemorrágico diferente de la hemofilia A (p. ej., enfermedad de von Willebrand, hemofilia B).
    - * Infección activa por hepatitis B o C, determinado por la positividad de la carga vírica de HBsAg o VHC-ARN.
    - Evidencia serológica de infección activa por el VIH-1 o VIH-2, determinada por un recuento de linfocitos CD4+ < 200 células/mm3 y/o una carga vírica > 50 cg/mL.
    - *Inmunidad preexistente frente a AAVhu37.
    - *Cualquier diagnóstico actual de neoplasia maligna.
    - Diagnóstico confirmado o sospecha de enfermedades autoinmunes que requieren tratamiento inmunosupresor.
    - Índice de masa corporal > 35 kg/m2.
    - Contraindicación para el tratamiento con corticosteroides.
    - *Cualquier otra condición médica significativa que pudiera representar un riesgo para el paciente o afectar a la capacidad del paciente de recibir la transferencia génica después de completar su participación en este estudio preliminar.

    Tratamiento previo/concomitante:
    Los tratamientos o medicamentos enumerados no están permitidos en el momento de la inclusión, durante el estudio y tampoco permitirán la transición al ensayo de fase III si se inician durante este estudio preliminar.
    - Tratamiento antivírico contra la hepatitis B o C.
    - Premedicación para tolerar el tratamiento con FVIII.
    - Fármacos inmunomoduladores (distintos de los corticosteroides).
    - Efavirenz.
    - Emicizumab.
    - Cirugía mayor programada.

    Experiencia en un ensayo clínico previo/simultáneo:
    - Participación en cualquier ensayo con un medicamento en investigación para la hemofilia en los 3 meses previos a la selección (la participación en cualquier otro ensayo con medicamentos en investigación no estará permitida durante el estudio).
    - Ha recibido el mismo producto de terapia génica u otro.
    E.5 End points
    E.5.1Primary end point(s)
    Number of bleeds (all bleeds) per observation time for each participant (annualized bleeding rate - ABR)
    Número de hemorragias (todas las hemorragias) por tiempo de observación para cada participante (tasa de hemorragia anualizada, THA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint will be assessed over the course of the study, from enrollment into the study till the completion. The duration per single patient will be between a minimum of 6 months and a maximum of 12 months.
    El criterio de valoración se evaluará durante el transcurso del estudio, desde la selección en el estudio hasta su finalización. La duración por cada paciente individual será entre un mínimo de 6 meses y un máximo de 12 meses.
    E.5.2Secondary end point(s)
    1)Number of spontaneous bleeds per observation time for each participant (ABR)
    2)Number of treated bleeds per observation time for each participant (ABR)
    3)FVIII consumption
    4)Haem-A-QoL (haemophilia quality of life questionnaire) total Score
    5)Haem-A-QoL domains “Physical Health”, “Sports and Leisure”
    6)EQ-5D-5L (The European quality of life-5 dimension-5-level questionnaire) Visual Analogue Scale
    7)HJHS (haemophilia joint health score) score
    1) Número de hemorragias espontáneas por tiempo de observación para cada participante (tasa de hemorragia anualizada, THA)
    2) Número de hemorragias tratadas por tiempo de observación para cada participante (THA)
    3) Administraciones de FVIII
    4) Puntuación total de Haem-A-QoL (cuestionario de calidad de vida en hemofilia)
    5) Dominios "Salud física", "Deportes y ocio" de Haem-A-QoL
    6) Escala analógica visual EQ-5D-5L (cuestionario europeo de calidad de vida de 5 dimensiones y 5 niveles)
    7) Puntuación HJHS (haemophilia joint health score)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3) Endpoints will be assessed over the course of the study, from enrollment into the study till completion. The duration per single patient will be between a minimum of 6 months to a maximum of 12 months.
    4-6) On day 1.
    7) At screening, week 26 and End of Study.
    1-3) Los criterios de valoración se evaluaran durante el transcurso del estudio, desde la selección en el estudio hasta su finalización. La duración por cada paciente individual será entre un mínimo de 6 meses y un máximo de 12 meses.
    4-6) En el día 1.
    7) En la selección, la semana 26 y el final del estudio.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    This lead-in study will not have any investigational drug intervention, but will prospectively collect detailed information on bleeds, treatment with the prescribed medications, and quality-of-life data. This information will provide baseline data for the planned Phase 3 study and will be used for intra-individual comparison of the effectiveness of gene therapy product BAY 2599023 with current hemophilia treatment in Phase 3 study.
    En este estudio preliminar no se administrará ningún fármaco en investigación, pero se recogerá de forma prospectiva información detallada sobre hemorragias, tratamiento con la medicación prescrita y datos sobre calidad de vida. Esta información proporcionará datos iniciales para el ensayo de fase III planificado y se utilizará para la comparación intraindividual de la eficacia del producto de terapia génica BAY 2599023 con el tratamiento actual para la hemofilia en el ensayo de fase III.
    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.8.2 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Canada
    Japan
    Taiwan
    Turkey
    United States
    Belgium
    Bulgaria
    Denmark
    France
    Germany
    Italy
    Netherlands
    Norway
    Spain
    Switzerland
    United Kingdom
    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 study is defined as the date of last visit of the last patient in this lead-in study.
    El final del estudio se define como la fecha de la última visita del último paciente en este estudio preliminar.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 140
    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 either exit the study and continue with their usual factor VIII treatment or they roll-over in the intevertional Phase III trial if they meet the eligible criteria and are willing to consent.
    Los sujetos abandonan el estudio y continúan con su tratamiento habitual con factor VIII o bien pasan a participar en el ensayo intervencionista de fase III si cumplen con los criterios de selección y están dispuestos a dar su consentimiento.
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-02
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