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    Summary
    EudraCT Number:2013-004157-24
    Sponsor's Protocol Code Number:IgPro20_3004
    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:2014-02-27
    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 number2013-004157-24
    A.3Full title of the trial
    Multicenter, open-label extension study to investigate the
    long-term safety and efficacy of IgPro20 in maintenance
    treatment of chronic inflammatory demyelinating
    polyneuropathy (CIDP) in subjects completing study
    IgPro20_3003
    Estudio de extensión abierto y multicéntrico para evaluar la seguridad y eficacia a largo plazo de IgPro20 como tratamiento de mantenimiento de la polineuropatía desmielinizante inflamatoria crónica (CIDP), en pacientes que hayan completado el estudio IgPro20_3003
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)
    Estudio de extensión con tratamiento de mantenimiento con inmunoglobulina subcutánea (IgPro20) para la polineuropatía desmielinizante inflamatoria crónica (CIDP).
    A.4.1Sponsor's protocol code numberIgPro20_3004
    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 SponsorCSL Behring GmbH
    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 supportCSL Behring GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring GmbH
    B.5.2Functional name of contact pointClin Trial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressEmil-von-Behring-Strasse 76
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35041
    B.5.3.4CountryGermany
    B.5.4Telephone number34933671882
    B.5.6E-mailclinicaltrials@cslbehring.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Hizentra®
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHizentra®
    D.3.2Product code IgPro20
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman normal immunoglobulin (SCIg)
    D.3.9.2Current sponsor codeIgPro20
    D.3.9.3Other descriptive nameHizentra®
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Inflammatory Demyelinating Polyneuropathy (CIDP)
    Polineuropatía desmielinizante inflamatoria crónica (CIDP)
    E.1.1.1Medical condition in easily understood language
    Inflammatory disease of peripheral nervous system
    Enfermedad inflamatoria del sistema nervioso periférico.
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10061811
    E.1.2Term Demyelinating polyneuropathy
    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
    To evaluate long-term safety of high-dose IgPro20 in subjects who have participated in the SC Treatment Period of pivotal study IgPro20_3003
    Evaluar la seguridad a largo plazo de la dosis alta de IgPro20 en sujetos que hayan participado en el período de tratamiento SC del estudio fundamental IgPro20_3003
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    ? To evaluate the long-term safety of low-dose IgPro20.
    ? To evaluate the long-term efficacy of high-dose and low-dose IgPro20.
    Objetivos secundarios:
    ? Evaluar la seguridad a largo plazo de la dosis baja de IgPro20.
    ? Evaluar la eficacia de la dosis alta y de la dosis baja de IgPro20.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects having participated in the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
    - Written informed consent for study participation obtained before undergoing any study-specific procedures.
    - If treatment for CIDP is required, it has to include IgGs.
    - Subjects who completed study IgPro20_3003 before study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after study IgPro20_3004 is open for enrollment at the site.
    - Subjects who completed study IgPro20_3003 after study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after the completion visit of study IgPro20_3003
    - Haber participado en el período de tratamiento SC del estudio fundamental IgPro20_3003(NCT01545076).
    - Haber proporcionado el consentimiento informado por escrito para participar en el estudio antes de realizar ninguno de los procedimientos específicos del estudio.
    - En caso de que se requiera tratamiento para la CIDP, este deberá incluir la administración de IgG.
    - En relación con los pacientes que hayan realizado la visita de finalización del estudio IgPro20_3003 antes de que se iniciara el reclutamiento en el estudio IgPro20_3004 en el centro del estudio en el que participará el paciente, el reclutamiento no deberá llevarse a cabo más de 8 semanas después de que se haya iniciado el reclutamiento del estudio IgPro20_3004 en el centro del estudio en el que participará el paciente.
    - En relación con los pacientes que hayan completado el estudio IgPro20_3003 después de que se iniciara el reclutamiento en el estudio IgPro20_3004 en el centro del estudio en el que participará el paciente, el reclutamiento no deberá realizarse más de 8 semanas después de que el paciente haya completado la visita de finalización del estudio IgPro20_3003
    E.4Principal exclusion criteria
    - Any polyneuropathy of other causes
    - Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
    - Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
    - History of thrombotic episodes within the 2 years prior to enrolment
    - Known allergic or other severe reactions to blood products including intolerability to previous IVIG (normal human immunoglobulin for intravenous administration) and/or SCIG (subcutaneous immunoglobulin)
    - Cualquier polineuropatía motivada por otras causas
    - Cualquier otra enfermedad (principalmente neurológicas, u ortopédicas de carácter crónico), que hayan provocado síntomas neurológicos o que puedan interferir con el tratamiento o la evaluación de los resultados
    - Enfermedades y trastornos graves que puedan interferir con la evaluación del producto en estudio o con el desarrollo satisfactorio del estudio
    - Antecedentes de episodios trombóticos en el transcurso de los 2 años previos al reclutamiento
    - Reacción alérgica u otra reacción intensa conocida a los productos sanguíneos. entre otras, intolerancia a IgIV y/o IgSC previos
    E.5 End points
    E.5.1Primary end point(s)
    Overall rate of adverse events (AEs) per infusion - high-dose IgPro20
    Tasa general de AA por infusión durante el período en el que se administre la dosis alta
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 48 weeks
    Hasta 48 semanas
    E.5.2Secondary end point(s)
    Safety:
    1. Rate of adverse events (AEs) per infusion by severity, causality, and seriousness - high-dose IgPro20
    2. Percentage of subjects with adverse events (AEs) - high-dose IgPro20
    3. Rate of adverse events (AEs) per infusion - low-dose IgPro20
    4. Percentage of subjects with adverse events (AEs) - low-dose IgPro20
    Efficacy:
    1. Total INCAT score at all study visits
    2. Time to first CIDP relapse
    Seguridad:
    1. Tasa de AA por infusión por intensidad, causalidad y gravedad) dosis alta IgPro20
    2. Porcentaje de pacientes con AA durante el período en el que se administre la dosis alta IgPro20
    3. Tasa de AA por infusión durante el período en el que se administre la dosis baja IgPro20
    4. Porcentaje de pacientes con AA durante el período en el que se administre la dosis baja IgPro20
    Eficacia:
    1. Puntuación total de la escala INCAT a lo largo de todas las visitas del estudio.
    2. Tiempo transcurrido hasta la primera recaída de CIDP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety 1. and 2.= Up to 48 weeks
    Safety 3. and 4.= Up to 28 weeks

    Efficacy 1.= Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 17, 25, 33, 41, and at completion visit)
    Efficacy 2.= Up to 49 weeks
    Seguridad 1. and 2. = Hasta 48 semanas
    Seguridad 3. and 4. = Hasta 28 semanas

    Eficacia 1. = Hasta 49 semanas (basal [semana 1], semanas 2, 9, 17, 25, 33, 41 y visita de finalización)
    Eficacia 2. = Hasta 49 semanas
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health-related quality of life (HRQL)
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Australia
    Canada
    European Union
    Israel
    Japan
    United States
    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
    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 months9
    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 months9
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 70
    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 care for CIDP
    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 Decision2014-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-10
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