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    Summary
    EudraCT Number:2011-003448-28
    Sponsor's Protocol Code Number:IgPro20_3003
    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:2012-03-29
    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 number2011-003448-28
    A.3Full title of the trial
    Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli teso a valutare l'™efficacia, la sicurezza e la tollerabilita' di 2 diverse dosi di IgPro20 (immunoglobulina per via sottocutanea [SC]) per il trattamento della polineuropatia demielinizzante infiammatoria cronica (CIDP) ' Studio PATH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)
    IgPro20 (immunoglobulina per via sottocutanea [SC]) per il trattamento della polineuropatia demielinizzante infiammatoria cronica (CIDP)
    A.3.2Name or abbreviated title of the trial where available
    PATH
    PATH
    A.4.1Sponsor's protocol code numberIgPro20_3003
    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 pointTrial Disclosure Manager
    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 number---
    B.5.5Fax number---
    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 AuthorisationGermany
    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 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
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor codeIgPro10-SOL
    D.3.9.4EV Substance CodeSUB14196MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous 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 Polyneuropathy (CIDP)
    Polineuropatia demielinizzante infiammatoria cronica (CIDP)
    E.1.1.1Medical condition in easily understood language
    Inflammatory disease of peripheral nervous system
    Malattia infiammatoria del sistema nervoso periferico
    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 10061811
    E.1.2Term Demyelinating polyneuropathy
    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
    To determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placebo.
    Determinare l’efficacia di 2 dosi diverse di IgPro20 (0,2 g/kg di peso corporeo e/o 0,4 g/kg di peso corporeo) nel trattamento di mantenimento della CIDP rispetto a placebo.
    E.2.2Secondary objectives of the trial
    - To investigate the efficacy of IgPro20 with additional clinical outcome measures in comparison to placebo. - To investigate the safety and tolerability of IgPro20 in comparison to placebo. - To investigate health-related quality of life (HRQL) following treatment with IgPro20.
    • valutare l’efficacia di IgPro20 rispetto a placebo in altre misure di esito clinico; • valutare la sicurezza e la tollerabilità di IgPro20 rispetto a placebo; • valutare la qualità di vita correlata alla salute (HRQL) dopo il trattamento con IgPro20.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010. 2. Repeated treatment with IVIG (≥ 4 infusions) within the last 9 months prior to enrollment. 3. An IVIG treatment during the last 8 weeks prior to enrollment. 4. Age ≥18 years. 5. Written informed consent for study participation obtained before undergoing any study-specific procedures.
    1. CIDP confermata o sospetta in base ai criteri EFNS/PNS 2010. 2. Trattamento ripetuto con IVIg (≥ 4 infusioni) negli ultimi 9 mesi prima dell’arruolamento. 3. Trattamento con IVIg nelle ultime 8 settimane prima dell’arruolamento. 4. Età ≥ 18 anni. 5. Consenso informato scritto alla partecipazione allo studio ottenuto prima di sottoporre il soggetto a qualsiasi procedura specifica dello studio.
    E.4Principal exclusion criteria
    1. Any polyneuropathy of other causes 2. Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment oroutcome assessments 3. Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study 4. History of thrombotic episodes within the 2 years prior to enrolment 5. Known allergic or other severe reactions to blood products including intolerability to previous IVIG
    1. Qualsiasi polineuropatia per altre cause;2. Eventuale altra patologia (principalmente di origine neurologica o ortopedica cronica) che abbia provocato sintomi neurologici o che possa interferire con le valutazioni del trattamento o degli esiti;3. Malattie e affezioni gravi che probabilmente interferirebbero con la valutazione del prodotto in studio o con la conduzione soddisfacente dello studio;4. Storia di episodi trombotici nei 2 anni precedenti l’arruolamento;5. Reazioni di tipo allergico o altre reazioni gravi note a prodotti ematici, inclusa l’intolleranza alla precedente IVIG.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage (%) of subjects who relapse during the SC treatment period
    Percentuale (%) di soggetti che manifestano recidiva* durante il trattamento SC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 settimane
    E.5.2Secondary end point(s)
    1. Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period 2. Change in mean maximum grip strength scores during the SC treatment period 3. Change in mean Medical Research Council (MRC) sum scores during the SC treatment period 4. Change in mean Rasch-built Overall Disability Scale (R-ODS) scores during the SC treatment period 5. Time to CIDP relapse 6. Rate of adverse events per SC infusion 7. Number of subjects with adverse events during the SC Treatment Period 8. Percentage of subjects with adverse events during the SC Treatment Period
    Variazioni nelle medie del punteggio INCAT durante il Periodo di trattamento SC 2-Variazioni nelle medie del punteggio forza di presa massima (mano dominante/non-dominante) durante il Periodo di trattamento SC ; 3-Variazioni nelle medie del punteggio MRC complessivo durante il Periodo di trattamento SC ; 4- Variazioni nelle medie del punteggio del questionario R-ODS durante il Periodo di trattamento SC. Differenza nel “tempo alla recidiva della CIDP” Tasso di AE per infusione durante il Periodo di trattamento SC Numero di soggetti con AE durante il Periodo di trattamento SC 8- Percentuale di soggetti con AE durante il Periodo di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. - 4. SC week 1, SC week 25 5. up to 24 weeks 6. - 8. 24 weeks
    1. - 4. SC alla settimana 1, SC alla settimana 25 5. Fino a 24 settimane, 6.-8. 24 settimane
    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)
    Qualità di vita correlata alla salute (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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Argentina
    Australia
    Canada
    Korea, Republic of
    Switzerland
    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''
    ''LVLS''
    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 months20
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months28
    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.1.1Number 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.1.2.1Number of subjects for this age range: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 250
    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
    Terapia standard per 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 Decision2012-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
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