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    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2013-005558-31
    Sponsor's Protocol Code Number:I10E-1306
    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:2014-12-16
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-005558-31
    A.3Full title of the trial
    International, multicentre, efficacy and safety study of I10E in the
    maintenance treatment of patients with Chronic Inflammatory
    Demyelinating Polyradiculoneuropathy: Extension of PRISM study
    Estudio internacional y multicéntrico sobre la eficacia y la seguridad de I10E en el tratamiento de mantenimiento de pacientes con polirradiculoneuropatía desmielinizante inflamatoria crónica: Extensión del estudio PRISM I10E-1302
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exstension of the international study on efficacy and safety of I10E in CIDP patients
    Extensión del estudio internacional para eficacia y seguridad de I10E en pacientes con PDIC.
    A.3.2Name or abbreviated title of the trial where available
    PRISM 2
    A.4.1Sponsor's protocol code numberI10E-1306
    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 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 Address3, avenue des Tropiques, BP 40305 ? LES ULIS
    B.5.3.2Town/ cityCOURTABOEUF CEDEX
    B.5.3.3Post code91958
    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.3.1Product nameHuman normal 10% immunoglobulin for intravenous administrationn
    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.3.9.3Other 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. 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 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 Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
    Polirradiculoneuropatía desmielinizante inflamatoria crónica (CIDP)
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is
    an acquired paralytic illness affecting peripheral nerves and caused by a
    demyelinating process.
    Polirradiculoneuropatía desmielinizante inflamatoria crónica (CIDP) es
    una enfermedad de parálisis adquirida que afecta a los nervios periféricos y que está causada por un proceso desmielinizante.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    E.1.2System Organ Class 10029205 - Nervous 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
    The study is descriptive. The primary objective is to assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study.
    El estudio es descriptivo. El objetivo principal de este estudio es evaluar la eficacia de I10E administrado a una dosis reducida de mantenimiento para mantener la respuesta de la PDIC tras un tratamiento inicial de 6 meses en el estudio PRISM.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety of I10E in this patient population.
    El objetivo secundario es evaluar la seguridad de I10E en esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patient aged 18 years or more.
    2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ?1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
    3. Covered by national healthcare insurance system as required
    by local regulations.
    4. Written informed consent obtained prior to any study-related
    1. Ser un hombre o una mujer de 18 años en adelante.
    2. Un paciente con respuesta que haya completado la última visita del estudio PRISM I10E-1302, lo que se define como un paciente con una reducción 1 punto en la puntuación de la escala de discapacidad INCAT ajustada, entre el momento basal y la visita de fin del estudio (FdE) del estudio PRISM I10E-1302.
    3. Cobertura del sistema nacional de la seguridad social, tal y como exige la normativa local.
    4. Obtención del consentimiento informado por escrito, antes de ningún procedimiento del estudio.
    E.4Principal exclusion criteria
    Based on follow-up and results of analyses performed in PRISM
    I10E-1302 study, a patient may be eligible in PRISM 2 I10E-1306
    study if none of the following criteria is met:
    1. History of severe allergic reaction or serious adverse reaction to
    any Ig.
    2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
    3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
    4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
    5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
    6. History of personal or familial congenital thrombophilia or acquired thrombophilia.
    7. Factors contributing to venous stasis such as long-term bed confinement.
    8. Body mass index (BMI) ?40 kg/m².
    9. Protein-losing enteropathy characterised by serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria ?3.5 g/24 hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
    10. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
    11. Serum levels of Alanine aminotransferase (AST) or Aspartate
    aminotransferase (ALT) >2 times upper limit of normal range.
    12. Any other ongoing disease that may cause chronic peripheral
    neuropathy, such as toxin exposure, dietary deficiency,
    uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus
    erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
    13. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception. Effective contraceptives are injectable, patch or combined oestro-progestative or progestative contraceptives, Copper T or levonorgest releasing intra-uterine devices, depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptive implants, condoms or occlusive caps (diaphragm or
    cervical/vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the patient).
    En función del seguimiento y los resultados de los análisis realizados en el estudio PRISM I10E-1302, un paciente puede ser apto para el estudio PRISM 2 I10E-1306 si no se cumple ninguno de los siguientes criterios:
    1. Antecedentes de reacción alérgica grave o intensa a alguna Ig.
    2. Hipersensibilidad conocida a las Ig humanas o a cualquiera de los excipientes de I10E (glicina y polisorbato 80).
    3. Antecedentes de insuficiencia cardíaca (New York Heart Association [NYHA] III/IV), arritmia cardíaca no controlada, cardiopatía isquémica inestable o hipertensión no controlada.
    4. Antecedentes de enfermedad tromboembólica venosa, infarto de miocardio o accidente cerebrovascular.
    5. Factor de riesgo de hiperviscosidad de la sangre, como crioglobulinemia o neoplasia hematológica con gammapatía monoclonal.
    6. Antecedentes de trombofilia congénita, familiar o personal, o trombofilia adquirida.
    7. Factores que contribuyan a la estasis venosa, como la obligación de guardar cama durante un período prolongado.
    8. Índice de masa corporal (IMC) ? 40 kg/m².
    9. Enteropatía con pérdida de proteínas, caracterizada por niveles séricos de proteína < 60 g/l y niveles séricos de albúmina < 30 g/l, o síndrome nefrótico, caracterizado por proteinuria ? 3,5 g/24 horas, niveles séricos de proteína < 60 g/l y concentración sérica de albúmina < 30 g/l.
    10. Tasa de filtración glomerular < 80 ml/(min·1,73 m²) según la fórmula del grupo MDRD (Modified Diet in Renal Disease).
    11. Niveles séricos? de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 2 veces el límite superior de la normalidad.
    12. Cualquier otra enfermedad en curso que pueda causar neuropatía periférica crónica, como la exposición a sustancias tóxicas, deficiencias nutricionales, diabetes no controlada, hipertiroidismo, cáncer, lupus eritematoso sistémico u otras enfermedades del tejido conjuntivo, infección por el VIH, virus de la hepatitis B (VHB) o virus de la hepatitis C (VHC), enfermedad de Lyme, mieloma múltiple, macroglobulinemia de Waldenström, amiloidosis y neuropatía hereditaria.
    13. Mujeres con un resultado positivo en una prueba de embarazo en orina, en período de lactancia, o con capacidad para concebir que no utilicen un método anticonceptivo eficaz.
    Anticonceptivos eficaces son anticonceptivos con solo gestágeno o combinados (estrógenos más un gestágeno) en parches o inyectables, dispositivos intrauterinos T de cobre o con liberación intrauterina de levonorgestrel, medroxiprogesterona intramuscular de liberación prolongada, implantes subcutáneos de gestágeno, preservativos o capuchones oclusivos (diafragma o capuchones cervicales) con espermicida, verdadera abstinencia (cuando esté en consonancia con el estilo de vida preferido y habitual del paciente).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the responder rate at EOS
    Responders are defined as patients with either:
    - No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit.
    - An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.
    El criterio principal de valoración de la eficacia será la tasa de pacientes con respuesta en la visita de FdE.
    Los pacientes con respuesta son aquellos:
    -Sin cambios o con una reducción en la puntuación de la escala de discapacidad INCAT ajustada, y sin ningún cambio en el tratamiento para la PDIC, entre el momento basal y la visita de FdE.
    O bien
    -Con un aumento de 1 punto en la puntuación de la escala de discapacidad INCAT ajustada, sin necesidad de ningún cambio en el tratamiento para la PDIC, entre el momento basal y la visita de FdE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the inclusion (baseline), end of study visit
    En la inclusión (basal), visita de fin de estudio.
    E.5.2Secondary end point(s)
    Main secondary efficacy endpoints:
    ? Change from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.
    ? Responder rate at 24 weeks (visit V9).
    ? Time to relapse.
    ? Change from baseline to 24 weeks (Visit V9) and EOS visit in the following scores:
    ? Grip strength with the Martin Vigorimeter in both hands;
    ? Rasch-built Overall Disability Scale (R-ODS);
    ? Medical Research Council (MRC) 12 muscles sum score
    (0 to 5) and Rasch-modified MRC (0 to 3).
    Other secondary endpoints:
    - Percentage of patients at 24 weeks (Visit V9) and EOS visit with no requirement of change in CIDP treatment from baseline.
    - Change from baseline to 24 weeks (Visit V9) and EOS visit in Patient and Investigator Clinical Global Impression (CGI).
    -Cambio desde el momento basal hasta las 24 semanas (visita 9) y la visita de FdE en la puntuación de la escala de discapacidad INCAT ajustada.
    -Tasa de pacientes con respuesta a las 24 semanas (visita 9).
    -Tiempo hasta la recidiva.
    -Cambio desde el momento basal hasta las 24 semanas (visita 9) y la visita de FdE en las siguientes puntuaciones:
    ? Fuerza de prensión con el vigorímetro de Martin en ambas manos;
    ? Puntuación en la R-ODS (Rasch-built Overall Disability Scale);
    ? Puntuación total en los 12 músculos (0 a 5) del Medical Research Council (MRC; consejo de investigación médica de Reino Unido) y la MRC modificada según el modelo de Rasch (0 a 3).
    -Porcentaje de pacientes a las 24 semanas (visita 9) y en la visita de FdE sin necesidad de cambios en el tratamiento para la PDIC, respecto al momento basal.
    -Cambio desde el momento basal hasta las 24 semanas (visita 9) y la visita de FdE en la Impresión clínica global (CGI) del investigador y del paciente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the inclusion, at week 24 and at the end of study visit
    En la inclusión, en la semana 24 y en la visita de fin de 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 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 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 Yes
    E. trial design description
    Grupo único
    single arm
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    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 Visit Last Subject
    Ultima visita, 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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 25
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 30
    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 visita final los pacientes seran cambiados al tratamiento estandar normal para esa condición.
    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 Decision2015-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-28
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