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    The EU Clinical Trials Register currently displays   40628   clinical trials with a EudraCT protocol, of which   6628   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2010-023483-41
    Sponsor's Protocol Code Number:I10E -0718
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-01-04
    Trial results Removed from public view
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2010-023483-41
    A.3Full title of the trial
    A.4.1Sponsor's protocol code numberI10E -0718
    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 SponsorLFB BIOTECHNOLOGIES
    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.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 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.3.2Product code I10E
    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.3.10 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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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) Yes
    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
    a primary immunodeficiency as defined by the ESID and validated by a reference centre :
    • X-linked agammaglobulinemia (XLA)
    • Autosomal recessive inherited
    agammaglobulinemia (including autosomal
    recessive hyper-IgM syndrome)
    • Common variable immunodeficiency (CVID)
    • IgG subclass deficiency (at least 2 subclasses)
    with clinical manifestations of immunodeficiency
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10010112
    E.1.2Term Common variable immunodeficiency
    E.1.3Condition being studied is a rare disease No
    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 70 year old

    3. Has an humoral primary immunodeficiency as defined by the ESID and validated by the reference centers :
    • X-linked agammaglobulinemia (XLA)
    • Autosomal recessive inherited agammaglobulinemia (including autosomal recessive hyper-IgM syndrome)
    • Common variable immunodeficiency (CVID)
    • IgG subclass deficiency (at least 2 subclasses) with clinical manifestations of immunodeficiency

    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 >= 4 g/l within 6 months prior to the introduction of I10E or naïve. All these patients must be stabilized under I10E during the first 6 months during the study with IgG trough levels >= 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 >= 4 g/l within 6 months prior to the introduction of I10E

    2. Known allergy or history of serious adverse reaction to any IgG

    3. Patient with known antibodies to IgA

    4. Chronic renal insufficiency or creatinin clearance values < 80 ml/min in adult patients (Modified Diet in Renal Disease) or < 60 ml/min in paediatric patients (Schwartz formula)

    5. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, or severe hypertension

    6. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months

    7. Loop diuretic treatment within the last week before inclusion

    8. Any additional cause of immunodeficiency, other than a primary immunodeficiency (as acquired immunodeficiency, lymphocytopenia, neutropenia, malignancy of lymphoïd cells, allogeneic hematopoïetic stem cell transplantation)

    9. Need of routine premedication by steroid before IgG infusionsinfusions

    10. Acute infection requiring antibiotics within one week before inclusion

    11. Immunosuppressive agents, including anti-CD20 antibodies, within the last 6 months

    12. Need of therapy with forbidden medication (steroid bolus, prophylactic antibiotic) that cannot be discontinued during the study

    13. Protein-loosing enteropathy characterised by serum protein levels < 60 g/l and serum albumin levels < 30 g/l or nephrotic syndrome characterised by proteinuria >= 3.5 g/24 hours, serum protein levels < 60 g/l and serum albumin levels < 30 g/l

    14. Any serious medical conditions that would interfere with the clinical assessment of I10E or prevent the patient to comply with the protocol requirements

    15. Patient known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.

    16. Malignant disease other than a adequately treated basal cell or squamous cell skin carcinoma or in situ cervix carcinoma

    17. Administration of another investigational product within the last month

    18. Exposure to blood products or derivatives other than commercial IgG, within 3 months prior to inclusion.

    19. 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).

    20. 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.

    21. 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.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. 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 No
    E.8.1.2Open No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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 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.1.1.1In 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.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    F. 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.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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