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    Summary
    EudraCT Number:2011-000914-21
    Sponsor's Protocol Code Number:161003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-09-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-000914-21
    A.3Full title of the trial
    A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFECTIVENESS OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% SOLUTION (IGIV, 10%) FOR THE TREATMENT OF MILD TO MODERATE ALZHEIMER’S DISEASE (AD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL OF THE SAFETY AND EFFECTIVENESS OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% SOLUTION (IGIV, 10%) FOR THE TREATMENT OF MILD TO MODERATE ALZHEIMER’S DISEASE (AD)
    A.3.2Name or abbreviated title of the trial where available
    Phase 3 IGIV, 10% in AD
    A.4.1Sponsor's protocol code number161003
    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 SponsorBaxter Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxter Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Innovations GmbH
    B.5.2Functional name of contact pointGuido Wuerth, MD
    B.5.3 Address:
    B.5.3.1Street AddressWagramer Strasse 17-19
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1221
    B.5.3.4CountryAustria
    B.5.4Telephone number+43(0)1 20100 2473489
    B.5.5Fax number+43(0)120100717
    B.5.6E-mailguido_wuerth@baxter.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 KIOVIG 100 mg/ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG
    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 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 INNHuman normal immunoglobulin
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    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) 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 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
    Mild to moderate Alzheimer’s disease (AD)
    E.1.1.1Medical condition in easily understood language
    Mild to moderate Alzheimer’s disease (AD)
    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 15.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    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 evaluate the efficacy of IGIV, 10% treatment on change in cognitive performance and functional activities in subjects with mild to moderate AD, as compared to placebo.
    E.2.2Secondary objectives of the trial
    1.To evaluate the effects of IGIV, 10% treatment on additional outcomes, including global clinical status, neuropsychiatric behaviors, and changes in volumetric magnetic resonance imaging (MRI) parameters.
    2.To examine the effects of IGIV, 10% treatment on quality of life of subjects with mild to moderate AD and of their caregivers.
    3.To assess the safety of IGIV, 10% treatment in subjects with mild to moderate AD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    2-Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Imaging Sub-Study (voluntary neuroimaging)
    To evaluate the effects of IGIV, 10% treatment on changes in cerebral glucose metabolism.
    Restricted to a subset of study sites in North America.
    E.3Principal inclusion criteria
    1.Males or females of age 50 to 89 years inclusive at the time of screening.
    2.Written informed consent obtained from either the subject or the subject’s legally authorized representative prior to any study-related procedures.
    3.Written informed consent obtained from an able and competent caregiver who is willing to comply with the requirements of the protocol pertaining to him/her, including facilitating the subject’s participation in the study.
    4.Diagnosis of Probable AD according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 1984 criteria.
    5.Dementia of mild to moderate severity (MMSE 16-26 inclusive at the time of screening).
    6.Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis.
    7.Willingness to comply with the requirements of the protocol and ability to comply with testing and infusion regimen, including adequate corrected visual acuity and hearing ability.
    8.For at least 12 weeks prior to screening, on stable doses of AD medication(s) approved by local regulatory authorities. Subjects must not be on two acetylcholinesterase inhibitors concurrently.
    9.Venous access for repeated infusion and phlebotomy.
    10.If receiving psychoactive medications (e.g., antidepressants other than monoamine oxidase inhibitors [MAOIs] and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc.), must be on stable doses for at least 6 weeks prior to screening.
    11.For women of childbearing potential, the subject must have a negative pregnancy test at screening and must agree to employ adequate contraceptive measures (e.g. birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study.
    E.4Principal exclusion criteria
    1.Possible AD by NINCDS-ADRDA criteria or non-Alzheimer dementia (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, or dementia arising from other diseases or conditions such as Parkinson’s disease, vit. B12 deficiency, thyroid abnormalities).
    2.Current residence in a skilled nursing facility.
    3.Contraindication to undergoing MRI (e.g. pacemaker [with the exception of an MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a metal plate).
    4.Clinically signif. congestive heart failure (e.g. New York Heart Association [NYHA] Class III/IV symptoms or untreated Class II).
    5.History of unstable angina (angina at rest) or myocardial infarction within the 12 months prior to screening.
    6.Uncontr. hypertension defined as syst. blood pressure >160mmHg and/or diast. >100mmHg confirmed upon repeated measures.
    7.History of thrombosis and/or thromboembolic disease (central or peripheral) within the 12 months prior to screening.
    8.Known history of procoagulant abnormalities (e.g. factor V Leiden, antiphospholipid syndr., protein S/protein C deficiency, AT III deficiency).
    9.History of intracerebral hemorrhage within the 5 yrs prior to screening.
    10.Evidence of >4 microhemorrhages (regardless of their anatom. location or diag. characterization as “possible” or “definite”), a single area of superficial siderosis, a macrohemorrhage, major stroke, or multiple lacunae by a recent (within 3 months prior to screening) and/or the baseline MRI, as confirmed by an indep. qualified central reviewer.
    11.Head trauma with loss of consciousness, contusion, or open head injury within the 12 months prior to screening.
    12.Uncontr. seizure disorder as defined by ≥2 breakthrough seizures/year despite adequate antiepileptic drug (AED) treatment.
    13.Modified Hachinski score >4 at time of screening.
    14.Subjects with active malignancy or history of malignancy within 5 yrs prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix & stable prostate cancer not requiring treatment.
    15.Active autoimmune/neuro-immunologic disorder.
    16.Uncontr. major depression, psychosis, or other major psych. disorder(s).
    17.Poorly contr. diabetes, defined as glycosylated (or glycated) hemoglobin (HbA1c) ≥6.5% at screening.
    18.Creatinine clearance <50% of normal adjusted for age and gender, as calculated according to the Cockcroft-Gault formula, at the time of screening.
    19. Known history of untreated vit. B12 deficiency within 6 months prior to screening, or clinically signif. abnormally low vit. B12 at the time of screening
    20.Abnormal clinical chemistry panel or hemat. panel meeting any one of the following criteria:
    a.Serum alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN)
    b.Clinically signif. anemia that precludes repeated blood sampling or hemoglobin (Hgb) <10.0 g/dL
    c.Absolute neutrophil count (ANC) <1000 cells/µL
    d.Known coagulopathy or platelet counts <100,000 cells/µL
    e.Total serum protein >9 g/dL
    21.Known history of/positive serology at screening for one/more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) type 1/2 antibody.
    22.Immunoglobulin A (IgA) deficiency (<8 mg/dL).
    23.Known history of hypersensitivity following infusions of human blood/blood components (e.g. human Ig or human albumin).
    24.Currently receiving or has received immunomodulatory therapies (e.g. anti-TNF, anti-IL-1, interferon, anti-CD20) within 12 weeks prior to screening, with the exception of topical, ophthalmic or inhaled glucocorticoids, & low-dose systemic corticosteroids (prednisone <10 mg/day or its equivalent).
    25.Currently receiving or has received intravenous or subcutaneous Ig treatment within the 2 yrs prior to screening, or has received Ig in Baxter Protocol 160701.
    26.Currently receiving or has received at any time active immunization aimed at modulating AD progression.
    27.Currently receiving or has received within 12 months prior to screening any investig. device, drug or biologic (e.g. passive immunotherapies with monoclonal or polyclonal ab) aimed at modulating AD progression.
    28.Subject has been exposed to an IP or investig. device (not covered under Exclusion Criteria #26 or #27) within 12 weeks prior to screening or is scheduled to participate in another clinical study involving an IP or investig. device during the course of this study.
    29.Subject is a family member or employee of the investigator.
    30.Subject is nursing/intends to begin nursing during the course of the study.
    31.Any disorder or disease, or clinically signif. abnormality on laboratory or other clinical test(s) (e.g. blood tests, urine tests, electrocardiogram, chest xray), that in med. judgment may impede the subject’s participation in the study, pose increased risk to the subject, or confound the results of the study.
    E.5 End points
    E.5.1Primary end point(s)
    1.The cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog)
    2.Alzheimer’s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) inventory
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. ADAS-Cog: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months and 18 months (as well as at the early termination visit if applicable)
    2. ADCS-ADL: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months and 18 months (as well as at the early termination visit if applicable)
    E.5.2Secondary end point(s)
    Efficacy
    1.ADCS-Clinical Global Impression of Change (CGIC)
    2.Neuropsychiatric Inventory (NPI)
    3.Logsdon Quality of Life in Alzheimer’s Disease (QOL-AD)
    4.Impact of Alzheimer’s Disease on Caregiver Questionnaire (IADCQ)
    5.Rate of whole brain atrophy and ventricular enlargement using volumetric MRI
    Safety
    1.Number (percentage) of subjects experiencing related adverse events (AEs) and/or serious adverse events (SAEs)
    2.Number (percentage) of subjects experiencing any AEs and/or SAEs
    3.Number (percentage) of infusions temporally associated (defined as during or within 72 hours of completion of an infusion) with AEs and/or SAEs
    4.Number (percentage) of infusions associated with AEs and/or SAEs occurring during or within 7 days of completion of an infusion
    5.Number (percentage) of infusions causally associated with AEs and/or SAEs
    6.Number and proportion of infusions discontinued, slowed, or interrupted due to an AE
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. ADCS-CGIC: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months and 18 months (as well as at the early termination visit if applicable)
    2. NPI: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months and 18 months (as well as at the early termination visit if applicable)
    3. QOL-AD: Baseline, 6 months, 9 months, 12 months and 18 months (as well as at the early termination visit if applicable)
    4. IADCQ: Baseline, 6 months, 9 months, 12 months and 18 months (as well as at the early termination visit if applicable)
    5. Rate of whole brain atrophy and ventricular enlargement: Baseline, 9 months and 18 months
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    Canada
    Germany
    Israel
    Japan
    Poland
    Spain
    United Kingdom
    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 months8
    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 months11
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 302
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 171
    F.4.2.2In the whole clinical trial 402
    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)
    There are no plans for treatment with the investigational product after the subject has ended participation in the trial (whether they completed the trial or discontinued early). All subjects in the trial are already receiving standard of care because they are required to be on AD medication(s) approved by local regultory authorities for at least 12 weeks prior to screening and throughout the course of their participation.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-07
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