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    EudraCT Number:2011-001354-29
    Sponsor's Protocol Code Number:I10E-0719
    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:2012-07-19
    Trial results Removed from public view
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-001354-29
    A.3Full title of the trial
    An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
    Estudio multicéntrico, abierto, de eficacia y seguridad de I10E en pacientes con trombocitopenia inmune primaria (TPI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)
    Estudio abierto, multicéntrico de eficacia y seguridad de una inmunoglobulina humana (código de proyecto I10E) en pacientes con trombocitopenia inmune primaria (TPI)
    A.4.1Sponsor's protocol code numberI10E-0719
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/184/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLFB BIOTECHNOLOGIES
    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 supportLFB BIOTECHNOLOGIES
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressZA de Courtaboeuf, 3, avenue des Tropiques
    B.5.3.2Town/ cityLes Ulis Cedex
    B.5.3.3Post code91940
    B.5.4Telephone number+33169 82 70 10
    B.5.5Fax number+33169 82 72 72
    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.3.2Product code I10E
    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.3.10 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. 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) Yes
    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
    ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009)
    El diagnóstico de TPI se define según los criterios de la ASH de 2011 y el BCSH de 2010, con la adopción de los nuevos criterios terminológicos de consenso propuestos por un grupo de trabajo internacional (Rodeghiero y cols., 2009)
    E.1.1.1Medical condition in easily understood language
    Treatment of Immune thrombocytopenia (a group of disorders characterized by autoimmune destruction of platelet and insufficient platelet production leading to an increased risk of bleeding)
    Tratamiento de la trombocitopenia inmune (alteraciones caracterizadas por la destrucción autoinmune de plaquetas y producción insuficiente de plaquetas que da lugar a un mayor riesgo de sangrado)
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10023095
    E.1.2Term ITP
    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
    To assess the efficacy of I10E in increasing platelet count and controlling bleedings in patients suffering from primary Immune ThrombocytoPenia (ITP).
    Evaluar la eficacia de I10E en el aumento de la cifra de plaquetas y el control de los sangrados en pacientes con trombocitopenia inmune primaria (TPI).
    E.2.2Secondary objectives of the trial
    To assess the biological and clinical safety profile of I10E.
    Evaluar el perfil de seguridad clínica y biológica de I10E.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Both genders

    2. Age between 18 to 65 year old

    3. Chronic Primary ITP
    - ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009):
    ? Isolated thrombocytopenia diagnosed with platelet count
    <100 x 10exp9/l and no abnormality of cells of other haematological
    lineage and,
    ? Normal bone marrow (if available), or history of response to an
    ITP treatment (corticosteroids, IVIg, anti-D) and,
    ? Failure to find any other causes of thrombocytopenia.

    - Chronic ITP with bleeding(s) or an increased risk of bleeding:
    ? More than 12 months from diagnosis of ITP and,
    ? Platelet counts < 30 x 10exp9/l at the time of inclusion.
    Note: Refractory ITP may be included and is defined by the failure to achieve a response or by the loss of response after splenectomy and the need of treatment (s) to minimize the risk of bleeding considered as clinically
    significant by the investigator.

    4. Written informed consent.
    5. Patient is covered by health care insurance system.
    Criterios de inclusión:
    1. En este estudio podrán participar pacientes de ambos sexos.
    2. Edad entre 18 años y < 65 años.
    3. TPI primaria crónica:
    - El diagnóstico de TPI se define según los criterios de la ASH de 2011 y el BCSH de 2010, con la adopción de los nuevos criterios terminológicos de consenso propuestos por un grupo de trabajo internacional (Rodeghiero y cols., 2009):
    -Diagnóstico confirmado de trombocitopenia aislada con una cifra de plaquetas < 100 × 109/l y sin anomalías en otras líneas celulares sanguíneas y
    - Médula ósea normal (si está disponible), o antecedentes de respuesta a un tratamiento para la TPI (corticosteroides, Ig i.v., anti-D) e
    - Imposibilidad de determinar otras causas para la trombocitopenia.
    - TPI crónica con sangrados o un riesgo mayor de sangrado:
    - Más de 12 meses desde el diagnóstico de la TPI y
    - Cifra de plaquetas < 30 × 109/l en el momento de la inclusión.
    Nota: se pueden incluir casos de TPI resistente al tratamiento, definida como la imposibilidad de lograr una respuesta o como la pérdida de respuesta después de la esplenectomía y necesidad de tratamiento para minimizar el riesgo de sangrados considerado clínicamente significativo por el investigador.
    4. Consentimiento informado por escrito.
    5. El paciente está cubierto por un sistema de seguro sanitario.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to the active substance or to any of the excipients.

    2. Patient with IgA deficiency except if the absence of anti IgA antibodies is documented.

    3. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, or severe hypertension (systolic blood pressure > or = to160 mmHg and diastolic blood pressure > or = to 100 mmHg).

    4. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months.

    5. Patient known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.

    6. Treatment that could induce thrombocytopenia within 15 days prior to inclusion.

    7. Recent previous treatment, the action of which may interfere with the assessment of the investigational medicinal product:
    - Initiation of corticosteroids or regular increase in the steroid dose within the last 4 weeks (EMA/CHMP/BPWP/94033/2007 rev.2),
    - IVIg within the last 4 weeks,
    - Anti-D within the last 4 weeks,
    - Cyclosporin A within 4 weeks,
    - Immunomodulator (as vincristin, vinblastin) within the last month,
    - Immunosuppressor (azathioprine, cyclophosphamide) within the last 4 weeks,
    - Anti-CD20 (rituximab) within the last 4 months,
    - Antigonadotropin Hormone (danazol) within the last 6 months,
    - Thrombopoietin receptors agonist (eltrombopag, romiplostim) within the last 4 weeks,

    8. Splenectomy required during the study period or within the two previous months.

    9. Severe haemorrhagic syndrome whether life-threatening or not, such as intracranial haemorrhage, gastrointestinal haemorrhage, gynaecological
    haemorrhage with deglobulisation of more than 2g/dL or major cutaneous-mucosal haemorrhagic syndrome.

    10. Severe bleeding or planned surgery requiring platelets transfusion at time of inclusion, or whole blood transfusion.

    11. Plasma exchange 4 weeks before inclusion.

    12. Concomitant disease that may induce a secondary immune thrombocytopenia, as:
    - Clinical active systemic lupus erythematous with more than 4 American College of Rheumatology criteria,
    - Lymphoproliferative disease or active malignant condition requiring antineoplastic or cytotoxic treatment.

    13. Known hepatic disorder including total bilirubin > 2 x upper limit of normal range, alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 3 x upper limit of normal range.

    14. Known chronic renal insufficiency or creatinine clearance values < 80 ml/min in adult patients (Modified Diet in Renal Disease calculation).

    15. Medical history of haemolysis or haemolytic anaemia during prior IVIg therapy or any other concomitant disease of clotting system (i.e. haemophilia).

    16. Administration of another investigational medicinal product within the last month.

    17. Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient to comply with the protocol requirements.

    18. Pregnant with positive results on a urine pregnancy test or breastfeeding woman, or woman of childbearing potential without effective contraception (effective contraception are: injectable, patch or combined
    oral estro-progestative or progestative contraceptives, intra-uterine devices of type 'copper T' and levonorgest releasing IU systems, depot intramuscular medroxyprogesteron, subcutaneous implants of
    progestative contraceptive implants, barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the subject)).

    19. Anticipated poor compliance of patient with study procedures.

    20. Use of loop diuretics within a week prior the inclusion.

    21. History of alcohol or drug abuse.

    22. Previously included /enrolled in this clinical study.

    23. Body Mass Index ? 30 kg/m2
    1. Hipersensibilidad conocida al principio activo o a alguno de los excipientes.
    2. Paciente con deficiencia de IgA, excepto si se confirma la ausencia de anticuerpos anti-IgA.
    3. Antecedentes de insuficiencia cardíaca (grados III/IV de la NYHA), miocardiopatía, insuficiencia cardiaca congestiva o hipertensión grave (presión arterial sistólica ? 160 mm Hg y presión arterial diastólica ? 100 mm Hg).
    4. Antecedentes de episodios trombóticos (incluida trombosis venosa profunda, infarto de miocardio, accidente cerebrovascular o embolia pulmonar) en los últimos 12 meses.
    5. Pacientes con infección conocida por el virus de la hepatitis B, el virus de la hepatitis C o el virus de la inmunodeficiencia humana.
    6. Tratamiento que pudiera inducir trombocitopenia en los 15 días anteriores a la inclusión.
    7. Tratamiento reciente cuya acción puede interferir en la evaluación del producto en investigación:
    - Inicio de corticosteroides o aumento periódico de la dosis de corticosteroides en las 4 últimas semanas (EMEA/CHMP/BPWP/94033/2007 rev.2),
    - Ig i.v. en las 4 últimas semanas,
    - Anti-D en las 4 últimas semanas,
    - Ciclosporina A en las 4 últimas semanas,
    - Inmunomoduladores (como vincristina o vinblastina) en el último mes,
    - Inmunosupresores (azatioprina, ciclofosfamida) en las 4 últimas semanas,
    - Anti-CD20 (rituximab) en los 4 últimos meses,
    - Hormona antigonadotrópica (danazol) en los 6 últimos meses,
    - Agonista de los receptores de la trombopoyetina (eltrombopag o romiplostim) en las 4 últimas semanas,
    8. Necesidad de esplenectomía durante el periodo del estudio o en los dos meses anteriores.
    9. Síndrome hemorrágico severo potencialmente mortal o no, como hemorragia intracraneal, digestiva, ginecológica con pérdida de eritrocitos superior a 2 g/dl o síndrome hemorrágico mucocutáneo grave.
    10. Sangrado intenso o cirugía programada que requiera transfusión de plaquetas en el momento de la inclusión, o transfusión de sangre.
    11. Plasmaféresis 4 semanas antes de la inclusión.
    12. Enfermedad concomitante que puede inducir una trombocitopenia inmune secundaria, como:
    - Lupus eritematoso sistémico clínicamente activo con cumplimiento de más de 4 criterios del American College of Rheumatology,
    - Enfermedad linfoproliferativa o neoplasia maligna activa que requiera tratamiento antineoplásico o citotóxico.
    13. Trastorno hepático conocido, incluidos unos niveles de bilirrubina total > 2 veces el límite superior de la normalidad o de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 3 veces el límite superior de la normalidad.
    14. Diagnóstico de insuficiencia renal crónica o valores de aclaramiento de creatinina < 80 ml/min en pacientes adultos (cálculo según la fórmula del estudio Modified Diet in Renal Disease).
    15. Antecedentes médicos de hemólisis o anemia hemolítica durante el tratamiento previo con Ig i.v., o cualquier otra enfermedad concomitante del sistema de coagulación (p. ej., hemofilia).
    16. Administración de otro producto en investigación en el último mes.
    17. Cualquier enfermedad grave que pudiera interferir en la evaluación clínica de I10E o impedir que el paciente cumpla con los requisitos del protocolo.
    18. Pacientes con resultado positivo en la prueba de embarazo en orina o en período de lactancia, o mujeres con capacidad reproductora que no utilicen un método anticonceptivo eficaz (se consideran anticonceptivos eficaces: anticonceptivos inyectables, en parche u orales combinados o con progestágenos solo, dispositivos intrauterinos de tipo T de cobre y sistemas IU liberadores de levonorgestrel, medroxiprogesterona depot intramuscular, implantes subcutáneos de anticonceptivos progestágenos, métodos anticonceptivos de barrera: preservativo o tapón oclusivo (diafragma o capuchón cervical) utilizados con espermicida, abstinencia real (cuando esté en consonancia con el estilo de vida preferido y habitual del sujeto).
    19. Se prevé un mal cumplimiento de los procedimientos del estudio por parte del paciente.
    20. Uso de diuréticos del asa en la semana previa a la inclusión.
    21. Antecedentes de consumo de drogas o alcohol.
    22. Pacientes incluidos o reclutados con anterioridad en este estudio clínico.
    23. Índice de Masa corporal ? 30 kg/m2
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number and percentage of patients with responses (including complete responses) during the investigational period.

    Patients with response (R):
    - Platelet counts > or = to 30 x 10 exp9/l and at least 2-fold increase of baseline platelet count confirmed on at least 2 separate visits at least 7 days apart.
    - And absence of new bleeding.

    Patients with complete response (CR):
    - Platelet count > or = to 100 x 10 exp9/l, confirmed on at least 2 separate visits at least 7 days apart.
    - And absence of new bleeding.

    Patients with no response (NR):
    - Patients who are neither responder nor complete responder.

    Patients with loss of CR or R:
    - Platelet count < 100 x 109/l (from CR) or platelet count < 30 x 109/l or
    less than 2-fold increase of baseline platelet count (from R). Platelet
    counts confirmed on at least 2 separate visits approximately 1 day apart.
    - Or occurrence of new bleeding.
    Pacientes con respuesta (R):
    - Cifra de plaquetas ≥ 30 × 109/l y al menos dos veces mayor que la cifra de plaquetas basal, confirmándose este aumento en al menos 2 visitas realizadas con 7 días de diferencia por lo menos.
    - Y ausencia de nuevos sangrados.

    Pacientes con respuesta completa (RC):
    - Cifra de plaquetas ≥ 100 × 109/l, confirmada en al menos 2 visitas realizadas con 7 días de diferencia por lo menos.
    - Y ausencia de nuevos sangrados.

    Pacientes con ausencia de respuesta (NR):
    - Pacientes que no responden ni presentan respuesta completa.

    Pacientes con pérdida de RC o R:
    - Cifra de plaquetas < 100 × 109/l (desde una RC) o cifra de plaquetas < 30 × 109/l o menos de dos veces mayor que la cifra basal (desde una R). Cifra de plaquetas confirmada en al menos 2 visitas independientes con aproximadamente 1 día de diferencia.
    - O aparición de nuevos sangrados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    confirmed on at least 2 separate visits at least 7 days apart during the study period.
    Confirmado en al menos 2 visitas separadas almenos 7 días, durante el periodo de estudio.
    E.5.2Secondary end point(s)
    Efficacy criteria:
    - Number and % of patients with complete response (CR) during the investigational period.
    - Time to response i.e. time from starting treatment to time of platelet response achievement (platelet count > or = to 30 x 10 exp9/l) in the responder
    - Maximum platelet counts and time to reach the maximum platelet count.
    - Number and % of non-responders patients (NR) during the investigational period.
    - Number and % of patients with a loss of R and CR during the investigational period.
    - Duration of response defined as the number of days from the first day of the response (CR or R) to the first day of the loss of response (CR or R).
    - Number and % of patients with platelet count > or = to 50 x 10 exp9/l at Day 5, Day 6 and Day 7.
    - Evaluation of pre-existing bleedings (Khellaf score and WHO score assessed at baseline, Day 2, Day 14 and Day 30)

    Safety criteria:
    All adverse events (AEs), non serious or serious adverse events (SAEs), from
    all subjects followed throughout the clinical study will be recorded and
    reported regardless of whether the AE is determined to be related to the
    product or not (pre-medication is not permitted to avoid masking AEs).
    Safety evaluation will include the monitoring of the following items:
    - Vital signs (blood pressure, heart rate, temperature) will be monitored
    by the study nurse during infusions,
    - Other adverse events that occurred during and between both infusions
    will be noted by the study nurse or the investigator,
    - Adverse events that occurred during the follow-up period will be
    recorded by the patients in their diaries and reviewed carefully by the
    investigator at Day 14 and at the end-of-study visit,
    - Renal function, hepatic function and blood cells will be monitored by
    biological tests (see study plan table).
    All AEs that begin during the infusion or within 72 hours after an infusion
    will be classified and analysed as temporally associated AEs (TAAEs) i.e.
    infusional AEs. A phone call between the patient and the investigator is
    scheduled at Day 5 to ensure the collect of these AEs.
    The patient will be asked to complete carefully the diary (nature of event,
    severity, date of initiation, hour at initiation of symptoms, duration of
    AEs will be evaluated with regard to the infusion rates.
    In this study, worsening of thrombocytopenia and bleeding events will not be
    regarded as adverse events as they will already be reported as efficacy criteria.
    Criterios de eficacia:
    - Número y porcentaje de pacientes con respuesta completa (RC) durante el periodo de investigación.
    - Tiempo hasta la respuesta, es decir, tiempo desde el inicio del tratamiento hasta el momento de la consecución de respuesta de las plaquetas (cifra de plaquetas ≥ 30 × 109/l) en la población de pacientes con respuesta.
    - Cifra máxima de plaquetas y tiempo hasta alcanzar la cifra máxima de plaquetas.
    - Número y porcentaje de pacientes que no responden al tratamiento (NR) durante el periodo de investigación.
    - Número y porcentaje de pacientes con pérdida de la R o la RC durante el periodo de investigación.
    - La duración de la respuesta se define como el número de días desde el primer día de la respuesta (RC o R) hasta el primer día de la pérdida de respuesta (RC o R).
    - Número y porcentaje de pacientes con una cifra de plaquetas ≥ 50 × 109/l el Día 5, el Día 6 y el Día 7.
    - Evaluación de los sangrados preexistentes (puntuación de Khellaf y puntuación de la OMS evaluadas en el periodo basal, el Día 2, el Día 14 y el Día 30) (véase el Anexo 20.4).

    Criterios de Seguridad:
    Se anotarán y notificarán todos los acontecimientos adversos (AA) no graves y todos los acontecimientos adversos graves (AAG) experimentados por todos los pacientes en seguimiento durante el estudio clínico, independientemente de que se determine que el AA está relacionado con el producto en estudio o no lo está (no se permite el uso de premedicación para no enmascarar los AA).
    La evaluación de la seguridad incluirá la monitorización de los siguientes aspectos:
    - Las constantes vitales (presión arterial, frecuencia cardíaca y temperatura) serán monitorizadas por el personal de enfermería del estudio durante las infusiones,
    - El personal de enfermería del estudio o el investigador tomarán nota de otros acontecimientos adversos que se produzcan durante las infusiones y entre ambas,
    - Los pacientes anotarán en sus diarios los acontecimientos adversos que aparezcan durante el período de seguimiento y el investigador los revisará detenidamente el Día 14 y en la visita de final del estudio,
    - La función renal, la función hepática y los glóbulos sanguíneos se vigilarán mediante pruebas biológicas (véase la tabla del plan del estudio).
    Todos los AA que comiencen durante la infusión o en las 72 horas siguientes a una infusión se clasificarán y analizarán como AA relacionados en el tiempo (AART), es decir, AA relacionados con la infusión. Está programada una llamada telefónica entre el paciente y el investigador para el Día 5 con el fin garantizar la recogida de estos AA.
    Se pedirá al paciente que cumplimente minuciosamente el diario del paciente (naturaleza del episodio, intensidad, fecha de inicio, hora de inicio de los síntomas y duración de los síntomas).
    Los AA se evaluarán con respecto a las velocidades de infusión.
    En este estudio, el empeoramiento de la trombocitopenia y los episodios de sangrado no se considerarán acontecimientos adversos, ya que se notificarán como criterios de eficacia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see details provided in section E 5.2.
    Ver detalles dados en la sección E.5.2
    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. 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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Russian Federation
    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
    End of the study will be last patient last visit
    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 months0
    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 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 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: 40
    F.1.3Elderly (>=65 years) No
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    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)
    At the last visit patients will be switched to the normal standard of care for the condition
    En la última visita los pacientes pasarán al tratamiento estandar para su enfermedad.
    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 Decision2012-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-03
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