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    Summary
    EudraCT Number:2015-003653-17
    Sponsor's Protocol Code Number:992
    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:2016-08-11
    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 number2015-003653-17
    A.3Full title of the trial
    An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)
    Estudio multicéntrico, aleatorizado, prospectivo, abierto, para evaluar la seguridad y eficacia clínicas de la inmunoglobulina humana normal de administración intravenosa BT595 en pacientes con trombocitopenia inmune primaria (PTI) crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)
    Estudio multicéntrico, aleatorizado, prospectivo, abierto, para evaluar la seguridad y eficacia clínicas de la inmunoglobulina humana normal de administración intravenosa BT595 en pacientes con trombocitopenia inmune primaria (PTI) crónica
    A.4.1Sponsor's protocol code number992
    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 SponsorBiotest 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 supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotest AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLandsteinerstraße 5
    B.5.3.2Town/ cityDreieich
    B.5.3.3Post code63303
    B.5.3.4CountryGermany
    B.5.4Telephone number+34917088600
    B.5.5Fax number+496103801341
    B.5.6E-mail992@biotest.de
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIgG Next Generation
    D.3.2Product code BT595
    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 INNHuman Normal Immunoglobulin (iv)
    D.3.9.2Current sponsor codeBT595
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    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 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 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
    Chronic primary immune thrombocytopenia (ITP)
    Trombocitopenia inmune primaria (PTI) crónica
    E.1.1.1Medical condition in easily understood language
    Chronic primary immune thrombocytopenia (ITP)
    Trombocitopenia inmune primaria (PTI) crónica
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10051057
    E.1.2Term Idiopathic thrombocytopenia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of the study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30×109/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding.
    La finalidad principal de este estudio es evaluar la eficacia y la seguridad de BT595 en sujetos adultos con PTI crónica. El objetivo principal del estudio es determinar la tasa de sujetos con respuesta al tratamiento. La respuesta se define como una cifra de trombocitos ≥ 30 × 109/l que como mínimo duplica la cifra de trombocitos basal, confirmada al menos en 2 ocasiones distintas con un mínimo de 7 días de diferencia, y ausencia de hemorragia.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study, in addition to further efficacy assessments, is to evaluate the safety of BT595.
    Los objetivos secundarios de este estudio, además de otras evaluaciones de la eficacia, tienen por fin evaluar la seguridad del BT595.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the study and are willing to participate
    b) Male or female, aged 18 through 75 years, inclusive
    c) Diagnosis of chronic ITP (>12 months’ duration), including diagnosis of refractory ITP, and as defined by the International Working Group (Rodeghiero et al, 2009), where ITP is described as an autoimmune disorder characterized by isolated thrombocytopenia in the absence of other causes or disorders that may be associated with thrombocytopenia
    d) Treatment is indicated because of a high risk of bleeding or a need to raise the platelet count
    e) Mean screening platelet count of <30×109/L from 3 qualifying platelet counts performed within approximately 7 to 14 days before the start of treatment, with no individual platelet count above 35×109/L. The subject may be rescreened if the mean screening platelet count is ≥30×109/L.
    a) Consentimiento informado por escrito de los sujetos en el que afirman que entienden el propósito y los procedimientos necesarios para llevar a cabo el estudio y que están dispuestos a participar en él.
    b) Hombres y mujeres de edades comprendidas entre 18 y 75 años de edad, ambos inclusive.
    c) Diagnóstico de PTI crónica (> 12 meses de evolución), incluido el diagnóstico de PTI resistente, según la definición del Grupo Internacional de Trabajo (Rodeghiero et al., 2009), en la que la PTI se describe como un trastorno autoinmune caracterizado por una trombocitopenia aislada en ausencia de otras causas o trastornos que puedan cursar con trombocitopenia.
    d) El tratamiento está indicado porque existe un riesgo elevado de hemorragia o una necesidad de elevar la cifra de trombocitos.
    e) La cifra media de trombocitos en la fase de selección es < 30 × 109/l a partir de 3 recuentos plaquetarios considerados válidos realizados entre, aproximadamente, 7 y 14 días antes de iniciar el tratamiento, sin una cifra de trombocitos individual superior a 35 × 109/l. El sujeto podrá repetir la selección si la cifra media de trombocitos que se obtiene en la fase de selección es ≥ 30 × 109/l. (Nota: Si el sujeto repite la selección, todas las pruebas de laboratorio deben repetirse.)
    E.4Principal exclusion criteria
    a) Pregnancy or unreliable contraceptive measures or lactation period (females only)
    b) Known intolerance to immunoglobulins or comparable substances (e.g., vaccination reaction)
    c) Known intolerance to proteins of human origin or known allergic reactions to components of the study product
    d) Participation in another clinical study within 90 days before entering the study or during the study and/or previous participation in this study
    e) Employee or direct relative of an employee of the contract research organization, the study site, or Biotest
    f) Secondary thrombocytopenia or acquired medical conditions known to be associated with secondary thrombocytopenia, such as chronic lymphocytic leukemia; lymphoma; multiple myeloma; thyroid disease; or other forms of thrombocytopenia, such as drug induced thrombocytopenia; cirrhotic liver diseases; antiphospholipid syndrome; environmental thrombocytopenia; and bone marrow diseases
    g) Severe concomitant diseases that in the judgment of the investigator will interfere with the study, such as autoimmune hemolytic anemia, acute renal failure, and noncontrolled arterial hypertension
    h) Laboratory findings (e.g., abnormal laboratory values for hemoglobin, transaminase levels [alanine aminotransferase, aspartate aminotransferase], total bilirubin, creatinine, blood urea nitrogen, and immunoglobulins G, A, M) that preclude participation
    i) Positive Coombs test (direct and indirect)
    j) Planned invasive procedures during the time frame of the study
    k) Maintenance therapy with intravenous immunoglobulins (IVIgs) or infusion of IVIgs within 3 months before start of the study
    l) Unresponsive to previous IVIg treatment
    m) Additional therapy with high dose corticosteroids (equivalent to >30 mg prednisone/day), thrombopoietin receptor agonists, and/or immunosuppressives and/or other therapies (e.g., infusion of platelets) within 1 month before the start of the study (Note: Subjects on stable doses of ITP active treatment must not have modified the dose in the preceding 2 weeks and must maintain their prestudy dose during the study. Corticosteroids should not be given as a premedication. Rescue therapy with short courses [i.e., 1 to 4 days] of high dose steroids and IVIgs are allowed up to 2 weeks before study inclusion.)
    n) History of thrombotic events (including myocardial infarction, cerebral vascular accident [including stroke], pulmonary embolism, and deep vein thrombosis) 6 months before treatment start with BT595 or the presence of significant risk factors for thrombotic events
    o) Therapy with live attenuated virus vaccines 3 months before start of the study
    p) Selective, absolute immunoglobulin A (IgA) deficiency or known antibodies to IgA
    a) Embarazo, métodos anticonceptivos no fiables o estar en periodo de lactancia (solo las mujeres).
    b) Intolerancia conocida a las inmunoglobulinas o sustancias comparables (por ejemplo, reacción a una vacuna).
    c) Intolerancia conocida a las proteínas de origen humano o reacciones alérgicas conocidas a los componentes del producto en estudio.
    d) Participar en otro estudio clínico en los 90 días previos a la inclusión en el estudio o durante el estudio o haber participado previamente en este estudio.
    e) Ser empleado o familiar directo de algún empleado de la organización de investigación por contrato, del centro del estudio o de Biotest.
    f) Trombocitopenia secundaria o cualquier afección médica adquirida que se sabe que está asociada a una trombocitopenia secundaria, tales como leucemia linfocítica crónica, linfoma, mieloma múltiple o enfermedad tiroidea, o bien otras formas de trombocitopenia como la trombocitopenia farmacógena, la cirrosis hepática, el síndrome antifosfolipídico, la trombocitopenia ambiental y las enfermedades de la médula ósea.
    g) Enfermedades concomitantes graves que, a juicio del investigador, interferirían en el estudio, como la anemia hemolítica autoinmune, la insuficiencia renal aguda y la hipertensión arterial no controlada.
    h) Resultados de laboratorio (por ejemplo, valores anormales de hemoglobina, niveles de transaminasas [alanina aminotransferasa, aspartato aminotransferasa], bilirrubina total, creatinina, nitrógeno ureico en sangre e inmunoglobulinas G, A y M) que impiden la participación en el estudio clínico.
    i) Resultado positivo en la prueba de Coombs (directa e indirecta).
    j) Procedimientos invasivos planificados durante el periodo del estudio.
    k) Tratamiento de mantenimiento con inmunoglobulinas (IVIg) administradas por vía intravenosa o infusión de IVIg en los 3 meses previos al inicio del estudio.
    l) Resistencia al tratamiento con IVIg previo.
    m) Terapia adicional con una dosis elevada de corticoesteroides (equivalente a > 30 mg de prednisona/día), agonistas de los receptores de trombopoyetina, inmunosupresores y/u otras terapias (por ejemplo, infusión de trombocitos) en el mes previo al inicio del estudio (Nota: Los sujetos que reciben un tratamiento activo para la PTI a dosis estables no pueden modificar la dosis en las 2 semanas previas al inicio del estudio y deben mantener su dosis previa al estudio a lo largo del estudio clínico. Los corticoesteroides no deben administrarse como premedicación. Los tratamientos de rescate en ciclos cortos [por ejemplo, de 1 a 4 días] de dosis elevadas de esteroides y IVIg se permiten hasta 2 semanas antes de incluir el sujeto en el estudio.)
    n) Antecedentes de episodios trombóticos (como infarto de miocardio, accidente cerebrovascular [incluido el ictus], embolia pulmonar y trombosis venosa profunda) en los 6 meses previos al inicio del tratamiento con BT595 o presencia de importantes factores de riesgo de episodios trombóticos.
    o) Terapia con vacunas elaboradas con microbios vivos atenuados en los 3 meses previos al inicio del estudio.
    p) Déficit absoluto y selectivo de inmunoglobulina A (IgA) o de anticuerpos conocidos frente a la IgA.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of subjects with response (R): defined as subjects with a platelet count of ≥30×109/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding
    Tasa de sujetos con respuesta (R): sujetos con una cifra de trombocitos ≥ 30 × 109/l que como mínimo duplica la cifra de trombocitos basal, confirmada al menos en 2 ocasiones distintas con un mínimo de 7 días de diferencia, y ausencia de hemorragia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day1, Day2 through Day5, Day8, Day15, Day22, + Day29 approx. Day36
    Día 1, Día 2 a Día 5, Día 8, Día 15, Día 22, + Día 29 aprox. Día 36
    E.5.2Secondary end point(s)
    Number and percentage of subjects with:
    - Complete response (CR): defined as a platelet count ≥100×109/L, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding.
    - No response (NR): defined as subjects without R, i.e., defined as a platelet count <30×109/L or less than a 2 fold increase of baseline platelet count, confirmed on at least 2 separate occasions, approximately 1 day apart, or bleeding.
    - Loss of response: only in subjects who previously had CR or R, defined as platelet count <100×109/L or bleeding (from CR) or <30×109/L or less than 2 fold increase of baseline platelet count, or bleeding (from R). Platelet counts confirmed on at least 2 separate occasions approximately 1 day apart.
    • Time to R: defined as the time from the start of treatment to time of achievement of R or CR.
    • Duration of R: defined as the time from the achievement of CR or R to loss of CR or R.
    • Number and percentage of subjects with response to ≥50×109/L: defined as a platelet count increase to at least ≥50×109/L within 7 days of the first BT595 infusion.
    • Subject’s maximum platelet count achieved.
    • Time to subject’s maximum platelet count.
    • Time course of platelet count.
    • Occurrence of bleeding symptoms assessed by physical examination using both the ITP specific bleeding assessment tool (Rodeghiero et al, 2013) and the World Health Organization bleeding scale (Miller et al, 1981).
    Número y porcentaje de sujetos con:
    - Respuesta completa (RC): cifra de trombocitos ≥ 100 × 109/l, confirmada al menos en 2 ocasiones distintas con un mínimo de 7 días de diferencia, y ausencia de hemorragia.
    - Sin respuesta (SR): sujetos que no ofrecen ninguna respuesta (R) al tratamiento, es decir, con una cifra de trombocitos < 30 × 109/l o inferior a 2 veces la cifra de trombocitos basal, confirmada al menos en 2 ocasiones distintas con aproximadamente 1 día de diferencia, o hemorragia.
    - Pérdida de respuesta: únicamente en los sujetos que previamente obtuvieron R o RC, definida como una cifra de trombocitos < 100 × 109/l o hemorragia (a partir de la RC) o una cifra de trombocitos < 30 × 109/l o inferior a 2 veces la cifra de trombocitos basal, o hemorragia (a partir de la R). Cifra de trombocitos confirmada al menos en 2 ocasiones distintas con aproximadamente 1 día de diferencia.
    • Tiempo hasta la R, definido como el tiempo que transcurre entre el inicio del tratamiento y hasta que se logra una R o RC.
    • Duración de la R, definida como el tiempo que transcurre entre que se logra una R o RC y la pérdida de dicha R o RC.
    • Número y porcentaje de sujetos con respuesta hasta ≥ 50 × 109/l, definida como un aumento de la cifra de trombocitos de como mínimo ≥ 50 × 109/l en los 7 días siguientes a la primera infusión de BT595.
    • Cifra de trombocitos máxima que ha logrado el sujeto.
    • Tiempo que transcurre hasta que el sujeto alcanza la cifra máxima de trombocitos.
    • Evolución temporal de la cifra de trombocitos.
    • Aparición de síntomas hemorrágicos evaluados mediante exploración física, usando tanto el instrumento de evaluación hemorrágica específica de la PTI (Rodeghiero et al., 2013) como la escala de valoración de hemorragias de la Organización Mundial de la Salud (Miller et al., 1981).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day1, Day2 through Day5, Day8, Day15, Day22, + Day29 approx. Day36
    Día 1, Día 2 a Día 5, Día 8, Día 15, Día 22, + Día 29 aprox. Día 36
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    Última visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months19
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months19
    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: 35
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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)
    None
    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 Decision2016-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-21
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