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    Summary
    EudraCT Number:2010-019459-23
    Sponsor's Protocol Code Number:170903
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-019459-23
    A.3Full title of the trial
    A CLINICAL STUDY OF IMMUNE GLOBULIN SUBCUTANEOUS (HUMAN) (IGSC), 20% FOR THE EVALUATION OF EFFICACY, SAFETY, AND PHARMACOKINETICS IN SUBJECTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL STUDY OF THE EFFICACY AND SAFETY OF SUBCUTANEOUS IMMUNE GLOBULIN, 20% IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
    A.3.2Name or abbreviated title of the trial where available
    EU Study of IGSC, 20% in PID
    A.4.1Sponsor's protocol code number170903
    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 pointSusanne Schmiedl
    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(1)20100 2471172
    B.5.5Fax number+43(1)20100717
    B.5.6E-mailsusanne_schmiedl@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
    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.3.1Product nameKIOVIG
    D.3.2Product code IGIV, 10%
    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.3.9.1CAS number 0
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 SUBCUVIA
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSUBCUVIA
    D.3.2Product code IGSC, 16%
    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.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.IMP: 3
    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 No
    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 nameImmune Globulin Subcutaneous, 20%
    D.3.2Product code IGSC, 20%
    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.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN
    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
    Primary Immunodeficiency Diseases
    E.1.1.1Medical condition in easily understood language
    Congenital diseases resulting in low immunoglobulin levels in the blood
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064859
    E.1.2Term Primary immunodeficiency syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of Immune Globulin Subcutaneous (Human) (IGSC), 20% in subjects with PID.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study, in addition to further efficacy assessments, are to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of Immune Globulin Subcutaneous (Human) (IGSC), 20% in subjects with PID.

    Exploratory Objective(s)
    Exploratory objectives are to assess dose adjustments, quality of life aspects, treatment satisfaction and treatment preference.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet ALL of the following criteria are eligible for this study:

    1. Subject must have a documented diagnosis of a form of primary humoral immunodeficiency involving antibody formation and requiring gammaglobulin replacement, as defined according to the IUIS Scientific Committee 2009 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with IP in the study.

    2. Subject is 2 years or older at the time of screening.

    3. Written informed consent is obtained from either the subject or the subject’s legally authorized representative prior to any study-related procedures and study product administration.

    4. Subject has been receiving a consistent monthly equivalent dose of IgG over a period of at least 3 months prior to first treatment with IP at an average minimum dose over that interval equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks. Examples of pre-study dosing frequency:
    a) IV at mean intervals of approximately 3 or 4 weeks or
    b) SC at mean intervals of approximately 1 or 2 weeks
    c) SC alternative treatment schedule (e.g. 2x/week)

    5. Subject has a serum trough level of IgG >5 g/L at screening

    6. Subject has not had a serious bacterial infection within the 3 months prior to screening.

    7. Subject is willing and able to comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    Subjects who meet ANY of the following criteria are not eligible for this study:

    1. Subject has a known history of or is positive at screening for one or more of the following:
    hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2.

    2. Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
    a) Persistent alanine aminotransferase (ALT) and aspartate amino transferase (AST) >2.5 times the upper limit of normal for the testing laboratory
    b) Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] ≤500/mm3)

    3. Subject has creatinine clearance (CLcr) value that is <60% of normal for age and gender.

    4. Subject has been diagnosed with or has a malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years.

    5. Subject is receiving anti-coagulation therapy or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within 12 months prior to screening or a history of thrombophilia.

    6. Subject has abnormal protein loss (protein losing enteropathy, nephrotic syndrome).

    7. Subject has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site.

    8. Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or Immune Serum Globulin (ISG) infusions.

    9. Subject has severe immunoglobulin A (IgA) deficiency (IgA less than 0.07g/L) with known anti IgA antibodies and a history of hypersensitivity.

    10. Subject is on preventative (prophylactic) systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and cannot stop these antibiotics at the time of screening.

    11. Subject has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening.

    12. Subject has a bleeding disorder or a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of SC therapy.

    13. Subject has total protein >9 g/dL or myeloma, or macroglobulinemia (IgM) or paraproteinemia.

    14. Women of childbearing potential meeting any one of the following criteria
    a) subject presents with a positive pregnancy test
    b) subject is breast feeding
    c) subject intends to begin nursing during the course of the study
    d) subject does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom [for male partner] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study.

    15. Subject has participated in another clinical study and has been exposed to an investigational product (IP) or device within 30 days prior to study enrollment (exception: treatment with immunoglobulin pre-study).

    16. Subject is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an IP or device during the course of the study.

    17. Severe dermatitis that would preclude adequate sites for safe product administration.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the acute serious bacterial infection rate defined as the mean number of acute serious bacterial infections per subject per year in the intent-to-treat population. Acute serious bacterial infections will include bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess, diagnosed according to the Diagnostic Criteria for Serious Acute Bacterial Infections of the US Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency, June 2008.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Infections will be reported as adverse events throughout the study and the number and types of infections will be determined.
    E.5.2Secondary end point(s)
    EFFICACY
    1. Pharmacokinetics
    a. Trough levels
    i. Immunoglobulin G (IgG) trough levels during approximately 3 months treatment with SUBCUVIA (subcutaneously) or KIOVIG (intravenously) (Study Epoch 1) and IgG trough levels after SC administration of IGSC, 20% (Study Epoch 2).
    ii. Trough levels of specific antibodies to clinically relevant pathogens (Clostridium tetani toxoid,
    Haemophilus influenzae and Hepatitis B Virus) during approximately 3 months treatment with
    SUBCUVIA (subcutaneously) or KIOVIG (intravenously) (Study Epoch 1) and trough levels of these specific antibodies after SC administration of IGSC, 20% (Study Epoch 2)
    b. Other PK parameters
    The following PK parameters will also be assessed for IgG: area under the curve (AUC), clearance
    (CL) for IV and apparent clearance (Cl/F) for SC administration, maximum concentration (Cmax),
    minimum concentration (Cmin), and time to maximum concentration (Tmax).

    2. Infections
    a. The annual rate of all infections per subject
    b. The annual rate of sinus infections per subject
    c. The annual rate of fever episodes per subject
    d. Days not able to attend school/work or to perform normal daily activities due to illness/infection
    e. Days on antibiotics
    f. Number of hospitalizations and length of stay (in days)
    g. Acute (urgent or unscheduled) physician visits due to illness/infection

    Safety:
    1. Related AEs
    a. Number of AEs (including and excluding infections) determined by the investigator to be related to the study drug that occur at any time during the study (“related”) divided by the number of subjects
    b. Number of AEs (including and excluding infections) determined by the investigator to be related to the study drug that occur at any time during the study (“related”) divided by the number of infusions

    2. All AEs
    a. Annual rate of serious adverse events (SAEs), related and not related
    b. Rates of AEs (including and excluding infections) defined as number of AEs categorized by Medical Dictionary for Regulatory Activities (MedDRA) preferred terms, seriousness, and severity, divided by the number of subjects
    c. Rates of AEs (including and excluding infections) defined as number of AEs categorized by MedDRA preferred terms, seriousness, and severity, divided by the number of infusions

    3. Local AEs
    a. Proportion of infusions in Study Epoch 1 and in Study Epoch 2 associated with one or more local AEs (including and excluding infections), at any time during the study
    b. Proportion of subjects in Study Epoch 1 and in Study Epoch 2 reporting one or more local AEs (including and excluding infections), at any time during the study

    4. Temporally associated AEs
    a. Number of AEs (including and excluding infections) that begin during the infusion or within 72 hours of completion of infusion divided by the number of subjects
    b. Number of AEs (including and excluding infections) that begin during or within 72 hours of
    completion of infusion divided by the number of infusions

    5. Short term tolerance
    a. Blood pressure
    b. Heart rate (pulse)
    c. Respiratory rate
    d. Body temperature
    e. Proportion of infusions for which the infusion rate was reduced and/or the infusion interrupted
    or stopped for tolerability concerns or for AEs
    f. Proportion of subjects for whom the infusion rate was reduced and/or the infusion interrupted or stopped for tolerability concerns or for AEs
    g. Proportion of infusions tolerated with intravenous (IV) or subcutaneous (SC) administration

    6. Hemolysis evaluation
    Occurrences of hemolysis at any time during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    IgG Trough Levels:
    • Baseline
    • Study Epoch 1
    - IV treatment: At each infusion (every 3 weeks or every 4 weeks)
    - SC treatment: Every 4 weeks (at the mandatory site infusion visit)

    • Study Epoch 2:
    - at infusion numbers 1, 5, and 13,
    - then weekly at infusion numbers 21, 22, 23, 24, 25, 26 and 27,
    - then every 8 weeks at infusion numbers 35, 43 and 51.

    • End-of-Study Visit
    Infections
    Throughout the study

    Safety Endpoints:
    Throughout the study

    Hemolysis Tests:
    - Screening visit
    - Once during IV and SC treatment in Epoch 1 (at the PK assessment infusion).
    - SC treatment Epcoch 2: At infusions 1, 2, 21, 22 and 52
    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) Yes
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 No
    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 subject.
    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 months3
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For children and adolescents, the subject's legally authorized representative has to give written informed consent prior to any study-related procedures and study product administration.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 47
    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)
    All patients will be on a stable regimen of intravenous or subcutaneous immunoglobulins for at least 3 months before entering the trial, and will return to their original treatment after the completion of the trial as prescribed by the investigator.
    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 Decision2010-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-13
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