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    EudraCT Number:2017-003538-10
    Sponsor's Protocol Code Number:BIVV009-03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-07
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-003538-10
    A.3Full title of the trial
    Estudio fundamental, abierto, multicéntrico para evaluar la eficacia y seguridad del BIVV009 en pacientes con enfermedad por crioaglutininas primaria que han recibido transfusiones sanguíneas recientemente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-Label with BIVV009 in patients with Cold Agglutinin Disease
    Estudio abierto con BIVV009 en pacientes con enfermedad por crioaglutininas primaria
    A.3.2Name or abbreviated title of the trial where available
    Cardinal Study
    A.4.1Sponsor's protocol code numberBIVV009-03
    A.5.4Other Identifiers
    Name:IND #Number:128,190
    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 SponsorBioverativ USA Inc.
    B.1.3.4CountryUnited States
    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 supportBioverativ USA Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioverativ USA Inc.
    B.5.2Functional name of contact pointClinical Trial Dept
    B.5.3 Address:
    B.5.3.1Street Address225 Second Avenue
    B.5.3.2Town/ cityWaltham, MA
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number003491 1459110
    B.5.5Fax number0034B.5.5 Fax number: 34 91 434277
    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 numberEMA/OD/177/15
    D.3 Description of the IMP
    D.3.1Product nameBIVV009
    D.3.2Product code BIVV009
    D.3.4Pharmaceutical form Solution for infusion
    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 INNBIVV009
    D.3.9.2Current sponsor codeBIVV009
    D.3.9.3Other descriptive nameCOMPLEMENT C1 ESTERASE INHIBITOR
    D.3.9.4EV Substance CodeSUB22696
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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
    Primary Cold Agglutinin Disease
    Enfermedad por crioaglutininas primaria
    E.1.1.1Medical condition in easily understood language
    Autoimmune Disease against red blood cells (Haemolytic Anaemia)
    Enfermedad autoinmune que ataca los glóbulos rojos (anemia hemolítica)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073785
    E.1.2Term Autoimmune haemolytic anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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:
    The primary objective of Part A is to determine whether BIVV009 administration results in a ≥ 2 g/dL increase in hemoglobin (Hgb) levels or increases Hgb to ≥ 12 g/dL and obviates the need for blood transfusion during treatment in patients with primary CAgD who have a recent history of transfusion

    Part B:
    The primary objective of Part B is to evaluate the long-term safety and tolerability of BIVV009 in patients with primary CAgD.
    Parte A:
    El objetivo principal de la Parte A es determinar si la administración del
    BIVV009 produce un aumento ≥ 2 g/ddll en el valor de hemoglobina
    (Hb) o si aumenta la Hb a un valor ≥ 12 g/ddll y evita la necesidad de
    transfusiones sanguíneas durante el tratamiento, en pacientes con
    enfermedad por crioaglutininas primaria que han recibido transfusiones
    Parte B:
    El objetivo principal de la Parte B es evaluar la seguridad a largo plazo y
    la tolerabilidad del BIVV009 en pacientes con enfermedad por
    crioaglutininas primaria.
    E.2.2Secondary objectives of the trial
    Part A:
    •To assess the effect of BIVV009 on clinical events and laboratory parameters related to hemolysis and anemia in patients with primary CAgD
    •To assess the effect of BIVV009 on quality of life (QOL) in patients with primary CAgD
    •To evaluate the overall safety and tolerability of BIVV009 in patients with primary CAgD
    •To assess the effect of BIVV009 on specific complications of CAgD
    •To evaluate the effect of BIVV009 on certain disease-related biomarkers in patients with primary CAgD
    •To evaluate the pharmacokinetics of BIVV009

    Part B:
    •The secondary objective of Part B is to investigate the durability of response during long-term treatment with BIVV009 in patients with primary CAgD.
    Parte A:
    •Evaluar el efecto del BIVV009 en los episodios clínicos y los parámetros
    de laboratorio de hemólisis y anemia en pacientes con enfermedad por
    crioaglutininas primaria.
    •Evaluar el efecto del BIVV009 sobre la calidad de vida (CdV) en
    pacientes con enfermedad por crioaglutininas primaria.
    •Evaluar la seguridad global y la tolerabilidad del BIVV009 en pacientes
    con enfermedad por crioaglutininas primaria.
    •Evaluar el efecto del BIVV009 sobre las complicaciones características
    de la enfermedad por crioaglutininas
    •Evaluar el efecto del BIVV009 sobre determinados biomarcadores
    asociados a la enfermedad en pacientes con enfermedad por
    crioaglutininas primaria.
    •Evaluar la farmacocinética del BIVV009
    Parte B
    • El objetivo secundario de la Parte B es estudiar la duración de la respuesta en el transcurso del tratamiento a largo plazo con BIVV009 en pacientes con enfermedad por crioaglutininas primaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Adult males and females ≥ 18 years of age at Screening
    2.Body weight of ≥ 39 kg at screening
    3.Confirmed diagnosis of primary CAgD based on the following criteria:
    a.Chronic hemolysis,
    b.Polyspecific direct antiglobulin test (DAT) positive,
    c.Monospecific DAT strongly positive for C3d,
    d.Cold agglutinin titer ≥ 64 at 4 degrees Celsius,
    e.IgG DAT ≤ 1+, and
    f.No overt malignant disease
    4.History of at least one documented blood transfusion within 6 months of enrollment
    5.Hemoglobin level ≤ 10.0 g/dL
    6.Bilirubin level above the normal reference range
    7.Ferritin level within the normal reference ranges unless outside normal range and deemed not clinically significant by the Investigator (or designee)
    8.Presence of one or more of the following CAgD-related signs or symptoms within 3 months of Screening:
    a.Symptomatic anemia defined as:
    iii.Shortness of breath,
    iv.Palpitations, fast heart beat
    v.Light headedness and/or
    vi.Chest pain
    c.Raynaud’s syndrome
    e.Disabling circulatory symptoms, and/or
    f.Major adverse vascular event (including thrombosis)
    9.Bone marrow biopsy within 6 months of Screening with no overt evidence of lymphoproliferative disease or other hematological malignancy. An additional bone marrow biopsy will be required if the prior bone marrow is deemed unsuitable for analysis by the Sponsor.
    10.Vaccinations against encapsulated bacterial pathogens (Neisseria meningitis, Meningitis B, Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years of enrollment or as specified in Appendix B.
    1.Hombres y mujeres adultos, de ≥ 18 años de edad en el momento de la
    2.Peso corporal ≥ 39 kg en el momento de la selección.
    3.Diagnóstico confirmado de enfermedad por crioaglutininas primaria,
    según los siguientes criterios:
    a.Hemólisis crónica,
    b.Prueba de antiglobulina directa (PAD) poliespecífica positiva,
    c.PAD monoespecífica marcadamente positiva para C3d,
    d.Título de crioaglutininas ≥ 64 a 4○C,
    e.PAD IgG ≤ 1+, y
    f.Ausencia de neoplasia maligna manifiesta.
    4.Antecedente confirmado de haber recibido, como mínimo, una
    transfusión sanguínea en los 6 meses previos a la inclusión.
    5.Valor de hemoglobina ≤ 10.0 g/dl.
    6.Valor de bilirrubina por encima del valor normal de referencia.
    7.Valor de ferritina dentro del intervalo de valores normales de
    referencia, salvo que se encuentre fuera del intervalo de normalidad
    pero que el investigador (o la persona que haya designado) considere
    que no tiene importancia clínica.
    8.Presencia de uno o más de los siguientes signos o síntomas de la
    enfermedad por crioaglutininas en los 3 meses previos a la selección:
    a.Anemia sintomática, definida como:
    iii.Dificultad para respirar,
    iv.Palpitaciones, frecuencia cardiaca acelerada
    v.Sensación de mareo y/o
    vi.Dolor torácico
    c.Síndrome de Raynaud
    e.Síntomas circulatorios incapacitantes y/o
    f.Complicaciones vasculares graves (incluida la trombosis)
    9.Biopsia de médula ósea en los 6 meses previos a la selección, sin
    evidencia manifiesta de enfermedad linfoproliferativa u otra neoplasia
    maligna hematológica. Será necesaria otra biopsia de médula ósea si el
    promotor considera que la biopsia anterior es inadecuada para su
    10.Vacunación contra bacterias patógenas encapsuladas (Neisseria
    meningitidis, Meningitis B, Haemophilus influenzae y Streptococcus
    pneumoniae) en los 5 años previos a la inclusión o según lo especificado
    en el Apéndice B.
    E.4Principal exclusion criteria
    1.Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy
    2.Clinically relevant infection of any kind within the month preceding enrollment (eg, active hepatitis C, pneumonia)
    3.Clinical diagnosis of systemic lupus erythematosus (SLE); or other autoimmune disorders with anti-nuclear antibodies at Screening
    4.Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening
    5.Positive human immunodeficiency virus (HIV) antibody at Screening
    6.Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (eg, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment
    7.Concurrent treatment with corticosteroids other than a stable daily dose equivalent to ≤ 10 mg/day prednisone for previous 3 months
    8.Erythropoietin deficiency. Concurrent treatment with erythropoietin is permitted if the patient has been on a stable dose for the previous 3 months.
    9.Concurrent usage of iron supplementation unless the patient has been on a stable dose for at least 4 weeks.
    10.Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the patient or compromise the quality of the data derived from his/her participation in this study (as determined by the Investigator [or designee]) at Screening
    11.Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half lives, whichever is greater, prior to treatment start
    12.Females who are pregnant, lactating, or, if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice
    1.Síndrome por crioaglutininas secundario a una infección, enfermedad
    reumatológica o neoplasia maligna hematológica activa.
    2.Infección clínicamente importante, de cualquier tipo, durante el mes
    anterior a la inclusión (p. ej., hepatitis C activa, neumonía).
    3.Diagnóstico clínico de lupus eritematoso sistémico (LES); u otros
    trastornos autoinmunitarios que presenten anticuerpos antinucleares en
    el momento de la selección.
    4.Resultado positivo de pruebas analíticas de hepatitis (incluidos el
    antígeno de superficie del virus de la hepatitis B y/o anticuerpos contra
    el virus de la hepatitis C) antes o en el momento de la selección.
    5.Presencia de anticuerpos contra el virus de la inmunodeficiencia
    humana (VIH) en el momento de la selección.
    6.Tratamiento con rituximab en monoterapia en los 3 meses previos a la
    inclusión o con rituximab en politerapia (p. ej., con bendamustina,
    fludarabina, ibrutinib o medicamentos citotóxicos) en los 6 meses
    previos a la inclusión.
    7.Tratamiento concomitante con corticoesteroides, distinto a una dosis
    estable diaria equivalente a ≤ 10 mg/día de prednisona durante los 3
    meses anteriores.
    8.Deficiencia de eritropoyetina. Se permite el tratamiento concomitante
    con eritropoyetina si el paciente ha estado recibiendo una dosis estable
    durante los 3 meses anteriores.
    9.Uso concomitante de suplementos de hierro, a menos que el paciente
    haya estado recibiendo una dosis estable durante 4 semanas como
    10.Antecedentes médicos clínicamente importantes o enfermedad crónica en curso que podrían amenazar la seguridad del paciente o
    comprometer la calidad de los datos derivados de su participación en
    este estudio (según lo determine el investigador [o la persona que se
    haya designado]), en el momento de la selección.
    11.Tratamiento concomitante con otros medicamentos experimentales o
    participación en otro ensayo clínico con cualquier medicamento en
    investigación en los 30 días o un periodo equivalente a 5 vida-media, el
    periodo que sea mayor, antes del inicio del tratamiento.
    12.Mujeres embarazadas, que estén dando el pecho o que, si son
    mujeres con capacidad de quedar embarazadas, se considere que no es
    posible garantizar que van a utilizar métodos anticonceptivos de forma
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the responder rate. A patient will be considered a responder if he or she did not receive a blood transfusion from Week 5 through Week 26 (EOT) and did not receive treatment for CAgD beyond what is permitted per protocol. Additionally, the patient’s Hgb level must meet either of the following criteria:
    • Hgb level is ≥ 12 g/dL at the treatment assessment endpoint (defined as mean value from Weeks 23, 25, and 26), or
    • Hgb increased ≥ 2 g/dL from baseline (defined as the last Hgb value before administration of the first dose of study drug) at treatment assessment endpoint
    El criterio de valoración principal de la eficacia es la tasa de pacientes con respuesta al tratamiento. Se considerará que un paciente responde al tratamiento si no ha recibido una transfusión sanguínea desde la semana 5 hasta la semana 26 (FDT) y tampoco ha recibido tratamiento para la enfermedad por crioaglutininas más allá de lo permitido por protocolo. Además, el valor de Hb del paciente deberá cumplir cualquiera de los siguientes criterios:
    • El valor de Hb es ≥ 12 g/dl al término del período de evaluación del tratamiento (definido como la media de los valores de las semanas 23, 25 y 26), o
    • Un aumento del valor de Hb ≥ 2 g/dl respecto al valor basal (definido como el último valor de Hb antes de la administración de la primera dosis del medicamento del estudio) al término del período de evaluación del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26 (EOT)
    Semana 26 (FDT)
    E.5.2Secondary end point(s)
    •Mean change from baseline in bilirubin (excluding patients with Gilbert’s Syndrome) at the treatment assessment endpoint (mean of values at Week 23, 25, and 26)
    •Mean change from baseline in QOL, as assessed by the change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale scores at the treatment assessment endpoint
    •Mean change from baseline in lactate dehydrogenase (LDH) at the treatment assessment endpoint
    •Number of transfusions and number of units after the first 5 weeks of study drug administration
    •Mean change from baseline in Hgb at the treatment assessment endpoint
    •Variación media del valor de bilirrubina respecto al valor basal
    (excluyendo a pacientes con síndrome de Gilbert) al término del período
    de evaluación del tratamiento (media de los valores en las semanas 23,
    25 y 26).
    •Variación media de la puntuación de CdV respecto a la puntuación
    basal, según la valoración del cambio en las puntuaciones de la escala de
    Evaluación funcional del tratamiento de enfermedades crónicas (FACIT)-
    Cansancio al término del período de evaluación del tratamiento.
    •Variación media del valor de lactato deshidrogenasa (LDH) respecto al
    valor basal al término del período de evaluación del tratamiento.

    •Número de transfusiones y número de unidades después de las primeras 5 semanas de administración del medicamento del estudio.
    •Variación media del valor de Hb respecto al valor basal al término del
    período de evaluación del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 26 (EOT)
    Semana 26 (FDT)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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. 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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    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
    Last subject Last Visit
    Ultima visita del último paciente
    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 years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    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 Yes
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 20
    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)
    Standard of care
    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 Decision2018-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
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