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    Summary
    EudraCT Number:2013-000961-36
    Sponsor's Protocol Code Number:KB057
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-05
    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 ConcernedGermany - PEI
    A.2EudraCT number2013-000961-36
    A.3Full title of the trial
    Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study.
    Bewertung der Verträglichkeit und Sicherheit der Verabreichung von Ig VENA bei hoher Infusionsrate. Offene Phase III-Studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    See the full title
    Eine Studie zur Untersuchung der Verträglichkeit von Ig VENA bei schneller Infusionsgeschwindigkeit
    A.3.2Name or abbreviated title of the trial where available
    Ig VENA Infusion Speed
    A.4.1Sponsor's protocol code numberKB057
    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 SponsorKedrion SpA
    B.1.3.4CountryItaly
    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 supportKedrion SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKedrion SpA
    B.5.2Functional name of contact pointManuela Scarpellini
    B.5.3 Address:
    B.5.3.1Street AddressLocalità Ai Conti
    B.5.3.2Town/ cityBarga/Lucca
    B.5.3.3Post code55051
    B.5.3.4CountryJersey
    B.5.4Telephone number003905831969602
    B.5.5Fax number003905831969600
    B.5.6E-mailm.scarpellini@kedrion.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 Ig VENA 50 g/l solution for infusion 100 ml vial + infusion set Ig VENA 50 g/l solution for infusion 200 ml vial + infusion set
    D.2.1.1.2Name of the Marketing Authorisation holderKedrion SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.11 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
    Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP)
    E.1.1.1Medical condition in easily understood language
    Patients affected by immunodeficiencies or platelets deficit
    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 PT
    E.1.2Classification code 10054979
    E.1.2Term Secondary immunodeficiency
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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 is to verify that the IMP can be administered at higher infusion speed than that currently reported in the SmPC in some patients already treated with IVIG with a good tolerability record, by progressively increasing the infusion rate during treatment cycles, up to a defined value of 8 ml/kg/h.

    The study is not intended to extend this way of administration to the whole patient population treated with the product.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for ID patients:
    1. Patients with a diagnosis of primary or secondary hypo-gammaglobulinaemia or a-gammaglobulinaemia.
    2. Males or females aged between 18 and 64 years (≥ 18 and ≤ 64 years).
    3. Patients in treatment with intravenous immunoglobulins for at least 6 months prior to study entry.
    4. Written informed consent and consent to handle personal data by participating subjects.
    Inclusion criteria for ITP patients:
    1. Patients with a diagnosis of persistent ITP (3 to 12 months from diagnosis) or chronic ITP (lasting for more than 12 months) .
    2. Males or females aged between 18 and 64 years (≥ 18 and ≤ 64 years).
    3. Patients who have made at least one previous treatment with immunoglobulin.
    4. Baseline platelet count: <20x109/l
    5. Written informed consent and consent to handle personal data by participating subjects.
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Patients who have not previously had therapy with immunoglobulins.
    2. Positivity for HIV, HCV, HBV, risky behaviour for blood-transmitted viral infections such as drug abuse or risky sexual relations
    3. Pregnant or breastfeeding women or women of childbearing age who do not use an adequate system of contraception.
    4. Severe systemic conditions or associated conditions contraindicating the use of immunoglobulins such as severe thrombocytopenia, clotting disorders, known deficiency of one or more IgG subclasses, IgA deficit or presence of IgA antibodies, allergic reactions to immunoglobulins or the presence of a history of severe adverse reactions to blood or blood products.
    5. Kidney disorders characterised by proteinuria ≥ 3.5 g/24hr, serum protein levels < 60 g/l or serum albumin levels < 30 g/l.
    6. Chronic kidney disease or creatinine clearance < 80 ml/min in accordance with the Cockroft formula.
    7. Subjects will be excluded from the study in the presence of any condition that in the Investigator’s opinion may interfere with the evaluation of study results.
    8. Patients unable to give Informed consent by themselves will be excluded (only for Germany)
    9. Subjects who had participated in a clinical trial with another product within one month (30 days) from enrolment or subjects who do not wish to give their consent to participate will be excluded from the study

    Exclusion criteria for ID patients:
    1. Acute bacterial infections requiring treatment with intravenous antibiotics within 1 week from enrolment
    2. History of heart failure (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension, lymphoma, hypoalbuminaemia, protein-losing enteropathy (characterised levels of serum protein < 60 g/l and serum albumin < 30 g/l)
    3. Positivity for thrombophilia test (homocysteine test, ATIII, Protein C and S, FV Leiden - screening test, Fibrinogen)

    Exclusion criteria (ITP Patients):
    1. History of heart failure (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension.
    2. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 month.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of tolerability and safety of Ig VENA administered at high infusion rates
    Valutazione della tollerabilità e della sicurezza di Ig VENA ad alte velocità di infusione
    E.5.1.1Timepoint(s) of evaluation of this end point
    For all the study period
    Per tutta la durata dello studio
    E.5.2Secondary end point(s)
    Not Applicable
    Non apllicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    Non Applicabile
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 35
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 35
    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)
    None
    Nessuna
    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 Decision2013-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-04
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