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    Summary
    EudraCT Number:2009-017672-24
    Sponsor's Protocol Code Number:IgPro10_3001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-017672-24
    A.3Full title of the trial
    A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)
    A.4.1Sponsor's protocol code numberIgPro10_3001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 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 Privigen®
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNHuman normal immunoglobulin G (IgG > 98% purity)
    D.3.9.1CAS number 0
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    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
    The objective of the study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following inclusion criteria may be enrolled into the study:
    • IVIG-untreated subjects: either subjects with newly diagnosed CIDP (developing
    over at least 2 months) or subjects with an IVIG treatment interruption for at least 1
    year with a progressive disease (deteriorating in the last 2 months) prior to
    enrolment
    OR
    IVIG-pretreated subjects being treated regularly with IVIG:
    - on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months
    - on a fixed dosage of ± 20 % in the last 6 months
    - deteriorating by at least 1 INCAT score point during the Washout Period of up to 10
    weeks (except for an increase from 0 to 1 solely due to upper limb score).
    • Diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory
    or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria
    for definite or probable CIDP according to EFNS/PNS guideline.
    - IVIG-untreated subjects need an actual diagnosis including electrophysiology.
    - IVIG-pretreated subjects need a historic diagnosis.
    • Age ≥18 years.
    • Male or female.
    • Written informed consent for study participation obtained before undergoing any
    study specific procedures.
    E.4Principal exclusion criteria
    Subjects meeting any of the following exclusion criteria must not be enrolled into the study:
    • A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with
    conduction block (i.e., upper limb motor weakness without sensory deficit and with a
    50% decrease in action potential amplitude or area on proximal compared with distal
    stimulation in motor nerves).
    • CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-
    MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)
    neuropathy.
    • Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or
    may interfere with treatment or outcome assessments with the INCAT (e.g.,
    diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the
    neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with
    radicolopathy, post-polio-syndrome, M. Parkinson, stroke).
    • Current malignancy.
    • History of cardiac insufficiency (New York Heart Association [NYHA] III/IV),
    cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or
    advanced ischemic heart disease, congestive heart failure or severe hypertension.
    • History of thrombotic episodes (deep vein thrombosis, myocardial infarction,
    cerebrovascular accident).
    • Migraine associated with IVIG infusion in the last 3 months prior to enrolment.
    • Known allergic or other severe reactions to blood products including intolerability to
    previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis).
    • Subjects with serum IgA level less than 50% of the lower normal limit.
    • Known hyperprolinemia.
    • Any condition (including alcohol, drug or medication abuse) that is likely to interfere
    with evaluation of the study product or satisfactory conduct of the study.
    • Plasma exchange 3 months prior to enrolment.
    • Treatment with immunomodulatory agents others than steroids, methotrexate or
    azathioprine (e.g. interferon, TNF-α inhibitors) within 6 months before enrolment.
    • Treatment with rituximab in the 12 months before enrolment.
    • Abnormal laboratory parameters: creatinine > 1.5 times the upper normal limit (UNL),
    lactate dehydrogenase (LDH) > 1.5 times the UNL, C-reactive protein (CRP) > 1.5
    times the UNL, hemoglobin (Hb) < 10 g/dL.
    • Ongoing HIV, hepatitis C and hepatitis B infection.
    • Participation in another clinical study (or use of another investigational medicinal
    product [IMP]) within 3 months prior to enrolment.
    • Not able to comply with study procedures and treatment regimen.
    • Employee at the study site, or spouse/partner or relative of any study staff (e.g.,
    investigator, sub-investigators, or study nurse).
    • Pregnancy or nursing mother.
    • Intention to become pregnant during the course of the study.
    • Female subjects of childbearing potential either not using, or not willing to use, a
    medically reliable method of contraception for the entire
    duration of the study, or not sexually abstinent for the entire duration of the study,
    or not surgically sterile.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the responder rate (ie, percentage of responders) based on the Inflammatory Neuropathy Cause and Treatment (INCAT) score, using the following definitions:
    • Responders are defined as those subjects who demonstrate a “clinically meaningful
    improvement”1) between baseline and Week 25.
    • Non-responders are defined as those subjects who fulfill 1 of the following 2
    conditions:
    a. Subjects who demonstrate no “clinically meaningful improvement” between
    baseline and Week 25, OR
    b. Subjects who are withdrawn from the study for any reason after the start of
    Privigen treatment without “clinically meaningful improvement”1) at the last
    study visit.
    1) “Clinically meaningful improvement” at a subject level is set at a decrease of at
    least 1 INCAT score point (except for a change of 1 to 0 solely due to upper limb
    score).
    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 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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    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
    last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.3Elderly (>=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 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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    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)
    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 Decision2010-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-29
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