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    Summary
    EudraCT Number:2005-001136-76
    Sponsor's Protocol Code Number:KB034Emendamenton°2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-001136-76
    A.3Full title of the trial
    Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study.
    STUDIO CONTROLLATO IN DOPPIO CIECO SULLA TOLLERABILITA` ED EFFICACIA DEL TRATTAMENTO PROLUNGATO CON IMMUNOGLOBULINE ENDOVENOSE AD ALTE DOSI (IVIG) VERSO METILPREDNISOLONE AD ALTE DOSI PER VIA ENDOVENOSA (MPIV) NELLA POLIRADICOLONEUROPATIA CRONICA INFIAMMATORIA DEMIELINIZZANTE (CIDP). STUDIO DI FASE III
    A.3.2Name or abbreviated title of the trial where available
    IVIg CIDP
    IVIg CIDP
    A.4.1Sponsor's protocol code numberKB034Emendamenton°2
    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 SponsorKEDRION
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 IGVENA*FL 200ML 10G+SET
    D.2.1.1.2Name of the Marketing Authorisation holderKEDRION SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Concentrate for 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 INNImmunoglobulins, normal human, for intravascular adm.
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number.5
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    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)
    Poliradicoloneuropatia cronica infiammatoria demielinizzante (CIDP)
    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 14.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study objective is to determine if IVIg treatment is better tolerate and/or more efficacious versus high doses intravenous metilprednisolone (MPIV) in CIDP induction (15 days) and long term improvement maintenance (6 months). This objective will be evaluated comparing the percentage of patients suspending IVIg and of patients suspending MPIV during the 6 months of treatment after undesiderable effects or treatment inefficacy (lack of response or worsening).
    L'obiettivo primario dello studio e' determinare se il trattamento con IVIg sia meglio tollerato e/o piu' efficace del metilprednisolone ad alte dosi per via endovenosa (MPIV) nell'induzione (15 giorni) e mantenimento del miglioramento a lungo termine (6 mesi) nella CIDP. Questo verra' valutato confrontando le percentuali dei pazienti che sospendono le IVIg e di quelli che sospendono il MPIV durante i sei mesi di trattamento a seguito di effetti collaterali o inefficacia del trattamento (mancata risposta o peggioramento).
    E.2.2Secondary objectives of the trial
    The second objective is to evaluate if IVIg treatment is more efficacious versus high doses intravenous metilprednisolone (IVMP)in relapse preventing after 6 months suspension of therapy.
    L'obiettivo secondario e' valutare se il trattamento con IVIg e' piu' efficace del metilprednisolone ad alte dosi per via endovenosa (MPIV) nel prevenire le recidive nei sei mesi successivi alla sospensione della terapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Typical CIDP in accordance with: 'European Federation of Neurological Societies/Peripheral Nerve Society' guidelines on management of chronic inflammatory demyelinating polyradoculoneuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society' (Journal of Peripheral Nervous System, 2005; 10(3):220-228). 2. Active or stationary phase of the disorder with non spontaneous improvement. 3 . > 18 years old and signed the Informed Consent Form 4. Significant disability in INCAT scale to the upper (2 or more) limbs or inferior limbs (1 or more) or to Rankin scale(2 or more).
    1. Il paziente deve essere affetto da CIDP definita tipica diagnosticata secondo i criteri clinici, neurofisiologici e strumentali stabiliti nelle: 'European Federation of Neurological Societies/Peripheral Nerve Society' guidelines on management of chronic inflammatory demyelinating polyradoculoneuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society' (Journal of Peripheral Nervous System, 2005; 10(3):220-228). 2. Il paziente deve essere in fase attiva o stazionaria della malattia e non in miglioramento spontaneo. 3 . Il paziente deve avere piu` di 18 anni e deve avere firmato il consenso informato 4. Il paziente deve avere un significativa disabilita` alla scala INCAT agli arti superiori (2 o piu`) o inferiori (1 o piu`) o alla scala di Rankin (2 o piu`).
    E.4Principal exclusion criteria
    1. Atypical CIDP (EFNS/PNS)
    1. CIDP atipica secondo EFNS/PNS 2.Presenza di patologie associate che possano causare una neuropatia quali diabete, gammopatia monoclonale IgM con AC anti-MAG o anti-solfatidi(la presenza di gammopatia monoclonale IgG o IgA non e` invece criterio di esclusione), neoplasia, infezione da HCV o da HIV, vasculiti, LES, ipotiroidismo, crioglobulinemia. 3.Gravidanza in atto o programmata. 4.Gravi patologie sistemiche o condizioni associate che controindichino l'uso di steroidi (scompenso cardiaco, ulcera peptica, cataratta, ipertensione arteriosa non controllata, storia di psicosi o schizofrenia) o IVIg (insufficienza renale, reazione allergica a IVIg). 5.Trattamento con dosi di steroidi &gt; 25 mg/die alterni o a 12.5 mg/die per os o ev. nei 3 mesi precedenti (il paziente puo` essere in trattamento con dosi di mantenimento di steroidi per os pari o inferiori a 25 mg/die alterni o 12.5 mg/die, sempre che queste non siano state aumentate negli ultimi 3 mesi). 6.Trattamento con IVIg nelle 8 settimane precedenti. 7.Storia di mancata risposta o intolleranza a dosi adeguate di steroidi (metilprednisolone e.v. 0.5 g per almeno 3 gg consecutivi o prednisone per os 1 mg/kg die per almeno 1 mese) o di IVIg (2g/kg/in 5 giorni o meno) . 8.Aumento della dose di eventuali altri farmaci immunosoppressori nei 12 mesi precedenti l'ammissione. 9.Interessamento clinico ed elettrofisiologico esclusivamente motorio di tipo multineuropatico compatibile con diagnosi di neuropatia motoria multifocale. 10.I soggetti potranno essere esclusi dallo studio in presenza di qualsiasi condizione che, a giudizio dello Sperimentatore, possa interferire con la valutazione dei risultati dello studio. 11.I soggetti che avessero partecipato ad uno studio clinico con un altro prodotto entro un mese (30 gg) prima dell'arruolamento, o che non volessero dare il loro consenso a partecipare, saranno esclusi dallo studio. 12.Numero di leucociti &gt;10/mm3 all'esame del liquor.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the percentage of patients suspending one of the therapies during 6 months of treatment after undesiderable effects or treatment inefficacy (lack of response or worsening) or both.
    1.Differenza nella percentuale dei pazienti che sospendono una delle terapie durante i sei mesi di trattamento a seguito di effetti collaterali o inefficacia del trattamento (mancata risposta o peggioramento) o entrambi.
    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.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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned18
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state46
    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 Decision2007-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
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