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    Summary
    EudraCT Number:2010-023483-41
    Sponsor's Protocol Code Number:I10E-0718
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-04-11
    Trial results Removed from public view
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2010-023483-41
    A.3Full title of the trial
    A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF
    I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune system
    A.4.1Sponsor's protocol code numberI10E-0718
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/184/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLFB BIOTECHNOLOGIES
    B.1.3.4CountryFrance
    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 supportLFB BIOTECHNOLOGIES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressZA de Courtaboeuf, 3, avenue des Tropiques
    B.5.3.2Town/ cityLes Ulis Cedex
    B.5.3.3Post code91940
    B.5.3.4CountryFrance
    B.5.4Telephone number+33169827010
    B.5.5Fax number+33169827272
    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 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 nameHUMAN NORMAL IMMUNOGLOBULIN FOR
    D.3.2Product code I10E
    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 FOR INTRAVENOUS USE
    D.3.9.2Current sponsor codeI10E
    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) Yes
    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
    a primary immunodeficiency as defined by the ESID and validated by a reference centre :
    • X-linked agammaglobulinemia (XLA)
    • Common variable immunodeficiency (CVID)
    E.1.1.1Medical condition in easily understood language
    immune system deficiency
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10010112
    E.1.2Term Common variable immunodeficiency
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10036700
    E.1.2Term Primary immunodeficiency syndromes
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10001471
    E.1.2Term Agammaglobulinemia
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of I10E in preventing acute serious bacterial infections
    E.2.2Secondary objectives of the trial
    To assess the safety, efficacy, pharmacokinetic of I10E
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Both genders
    2. Age between 2 to 65 year old
    3. Has an humoral primary immunodeficiency as defined by the ESIDs1
    and validated by the reference centers :
    · X-linked agammaglobulinemia (XLA)
    · Common variable immunodeficiency (CVID)
    4. The requirement of IVIG therapy at a dose between 0.2 to 0.8 g/kg
    and at administration interval of 3-weeks or 4-weeks may be
    considered medically necessary for the treatment of the patient
    condition
    5. Patient already under IgG replacement therapy with a stable dosage
    and with 3 documented trough levels ³ 4 g/l within 6 months prior to
    the introduction of I10E (trough levels should have been performed at
    3 to 8 weeks interval between samples or naïve. All these patients
    must be stabilized under I10E during the first 6 months during the
    study with IgG trough levels ³ 6 g/L).
    6. Written informed consent obtained prior to any study-related
    procedure and study product administration from either the patient or
    the patient's legal representative
    7. If required by national regulation, registered with a social security or
    health insurance system
    E.4Principal exclusion criteria
    1. Patient already under IgG replacement therapy with no 3 documented
    trough levels ³ 4 g/l within 6 months prior to the introduction of I10E
    or patient with 3 documented Ig G trough level not performed within
    defined 3 to 8 weeks interval between samples.
    2. Known allergy or history of serious adverse reaction to any IgG
    3. Known hypersensitivity to the active substance or to any of the
    excipients
    4. Patient with known antibodies to IgA
    5. Chronic renal insufficiency or creatinine clearance values < 80
    ml/min in adult patients (Modified Diet in Renal Disease) or < 60
    ml/min in paediatric patients (Schwartz formula)
    6. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy,
    congestive heart failure, or severe hypertension
    7. History of thrombotic episodes (including deep vein thrombosis,
    myocardial infarction, cerebrovascular accident, pulmonary
    embolism) within the last 12 months
    8. Loop diuretic treatment within the last week before inclusion
    9. Any additional cause of immunodeficiency, other than a primary
    immunodeficiency (as acquired immunodeficiency, neutropenia,
    malignancy of lymphoïd cells, allogeneic hematopoïetic stem cell
    transplantation)
    10. Need of routine premedication by corticosteroid before IgG
    infusions
    11. Acute infection requiring antibiotics within one week before
    inclusion
    12. Immunosuppressive agents, including anti-CD20 antibodies, within
    the last 6 months
    13. Need of therapy with forbidden medication (steroid bolus,
    prophylactic antibiotic) that cannot be discontinued during the study
    14. Protein-loosing enteropathy characterised by serum protein levels <
    60 g/l and serum albumin levels < 30 g/l or nephrotic syndrome
    characterised by proteinuria ³ 3.5 g/24 hours, serum protein levels <
    60 g/l and serum albumin levels < 30 g/l
    15. Any serious medical conditions that would interfere with the
    clinical assessment of I10E or prevent the patient to comply with the
    protocol requirements
    16. Patient known to be infected with hepatitis B virus, hepatitis C virus,
    or human immunodeficiency virus.
    17. Malignant disease other than a adequately treated basal cell or
    squamous cell skin carcinoma or in situ cervix carcinoma
    18. Administration of another investigational product within the last
    month
    19. Exposure to blood products or derivatives other than commercial
    IgG, within 3 months prior to inclusion.
    20. Pregnant with positive results on a HCG-based pregnancy blood test
    (> 12 years) or breastfeeding woman, or woman of childbearing
    potential with no effective contraception (injectable, patch or
    combined oral estro-progestative or progestative contraceptives,
    intra-uterine devices of type 'copper T' and levonorgest releasing IU
    systems, depot intramuscular medroxyprogesteron, subcutaneous
    implants of progestative contraceptives implants).
    21. Blood levels of total bilirubin > 2 x upper limit of normal range,
    alanine aminotransferase (ALT) or aspartate amino transferase (AST)
    > 3 x upper limit of normal range.
    22. Anticipated poor compliance of patient with study procedures
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number of acute serious bacterial infections
    (aSBI) per patient and per year (annualized rate) as defined by the FDA
    guidance 70 FR 72124 and evaluated by the DSMB:
    • bacteraemia or sepsis,
    • bacterial meningitis,
    • osteomyelitis / septic arthritis,
    • bacterial pneumonia,
    • visceral abscess.
    E.5.1.1Timepoint(s) of evaluation of this end point
    see protocol
    E.5.2Secondary end point(s)
    1) Efficacy criteria
    Serum total IgG trough levels:
    • Total IgG trough concentrations will be measured by nephelemetry
    (central lab) in serum obtained from blood samples collected prior to
    each infusion from all included patients during the 12 month-study
    period. In addition, distribution of IgG sub-classes and content of
    clinically relevant antibodies will be assessed.
    • Descriptive relationship between total IgG trough levels and serious
    all infections.
    Other efficacy criteria will be assessed both by investigator and patients
    follow-up diaries (annualized rate) :
    • Number of all infections per patient and per year: annualized rate of
    documented of serious and non-serious bacterial infections
    • Number of days missed from work or school due to infections,
    • Number of days hospitalized related to infections,
    • Number of days with use of antibiotics related to infections,
    • Number of fever episodes related to infections
    2) Safety criteria
    Adverse events (AEs), serious (SAEs) and non serious adverse events
    from all subjects followed throughout the clinical studies will be
    recorded and reported regardless of whether the AE is determined to
    be related to the product or not by the investigator (Pre-medication is
    discouraged to avoid masking AEs).
    Safety evaluation will include the monitoring of the following items:
    • Vital signs (blood pressure, heart rate, temperature) will be
    monitored by the study nurse during infusions within 30 mn
    after the end of the infusion
    • Laboratory tests including direct Coombs' test will be
    monitored at each visit
    • Adverse events that occurred during infusions will be noted
    by the study nurse or the investigator
    • Adverse events that occurred during intervals between
    infusions will be recorded by the patients in their diaries and
    reviewed by the investigator at each visit.
    • Renal function, hepatic function and blood cells will be
    monitored by biological tests.
    3) Pharmacokinetics (PK)
    E.5.2.1Timepoint(s) of evaluation of this end point
    see protocol
    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 Yes
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    France
    Czech Republic
    Hungary
    Lithuania
    Poland
    Serbia
    Ukraine
    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
    End of the study will be last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    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: 26
    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: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 13
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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
    Children and adolescents aged 2-17
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    At the last visit patients will be switched to the normal standard of care for the condition
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Serbia
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