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    Summary
    EudraCT Number:2010-019670-32
    Sponsor's Protocol Code Number:B1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-19
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-019670-32
    A.3Full title of the trial
    Pharmacokinetics and Safety of Human Pasteurised C1-Inhibitor Concentrate (Berinert/CE1145) in Subjects with Congenital C1-INH Deficiency and Frequent Hereditary Angioedema (HAE) Attacks.
    Studio della farmacocinetica e della sicurezza del C1-Inibitore concentrato pasteurizzato umano (Berinert/CE1145) in soggetti con deficienza congenita di C1-INH e frequenti attacchi di angioedema ereditario (HAE).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics and Safety of Human Pasteurised C1-Inhibitor Concentrate (Berinert/CE1145) in Subjects with Congenital C1-INH Deficiency.
    Studio della farmacocinetica e della sicurezza del C1-Inibitore concentrato pasteurizzato umano (Berinert/CE1145) in soggetti con deficienza congenita di C1-INH.
    A.4.1Sponsor's protocol code numberB1
    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 SponsorAZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCSL Behring
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale Luigi Sacco
    B.5.2Functional name of contact pointU. O. Medicina II
    B.5.3 Address:
    B.5.3.1Street Addressvia G.B. Grassi 74
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20157
    B.5.3.4CountryItaly
    B.5.4Telephone number+39-02-39042316
    B.5.6E-mailmarco.cicardi@unimi.it
    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 BERINERT*IV FL 500U+FL 10ML
    D.2.1.1.2Name of the Marketing Authorisation holderCSL BEHRING 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 Powder and solvent for solution for injection
    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 INNCE1145
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Hereditary Angioedema (HAE)
    angioedema ereditario
    E.1.1.1Medical condition in easily understood language
    Hereditary Angioedema (HAE)
    angioedema ereditario
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10056912
    E.1.2Term C1 esterase inhibitor deficiency
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the PK profile of CE1145 in patients with weekly angioedema attacks and rapid clearance of C1-INH from plasma after normalising activation of the complement and contact system by replacing the total C1-esterase inhibitor (C1-INH) plasma pool with repetitive C1-INH administrations.
    Studiare il profilo di PK del CE1145 in pazienti con attacchi settimanali di angioedema e rapida clearance plasmatica di C1-INH dopo normalizzazione del sistema del complemento di contatto sostituendo l’intero pool plasmatico dell’inibitore della C1-esterasi (C1-INH) con ripetute somministrazioni di C1-INH.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the safety of C1-INH treatment in these subjects.
    L’obiettivo secondario dello studio è di verificare la sicurezza del trattamento con C1-INH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who suffer from frequent angioedema attacks (every 3-7 days) in whom infused CE1145 is rapidly catabolized and does not significantly modify C4 levels. Written informed consent for study participation obtained before undergoing any study specific procedures.
    Pazienti soggetti a frequenti attacchi di angioedema (ogni 3-7 giorni) nei quali il CE1145 dato per infusione viene rapidamente catabolizzato e non modifica significativamente i livelli di C4. Il consenso informato scritto per la partecipazione allo studio deve essere ottenuto prima di effettuare qualunque procedura.
    E.4Principal exclusion criteria
    • Absence of HAE attack in the last 30 days before study enrolment.
    • Participation in another clinical study (or use of another investigational medicinal product [IMP]) within 30 days before, or during, the study.
    • History of alcohol, drug, or medication abuse within one year before the study.
    • Use of concomitant therapy not permitted during the study.
    • Suspected inability (eg, language problems) or unwillingness to comply with study procedures.
    • Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study).
    • Known or suspected hypersensitivity to the IMP, or to any excipients of the IMP.
    • Known or suspected antibodies to the IMP, or to any excipients of the IMP.
    • Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
    • Assenza di attacchi di HAE nei 30 giorni precedenti l’arruolamento nello studio.
    • Partecipazione ad un altro studio clinico (o uso di un altro prodotto medicinale sperimentale [IMP]) nei 30 giorni precedenti, o durante, lo studio.
    • Storia di abuso di alcool, droghe o farmaci nell’anno precedente l’inizio dello studio.
    • Uso, durante lo studio, di terapie concomitanti non permesse.
    • Sospetta incapacità (es, problemi di linguaggio) o indisponibilità alla attuazione delle procedure dello studio.
    • Condizione mentale che rende il soggetto (o il legale rappresentante [i] del soggetto) incapace di capire la natura, lo scopo e le possibili conseguenze dello studio.
    • Conosciuta o sospetta ipersensibilità all’IMP, o a qualche eccipiente dell’IMP.
    • Conosciuti o sospetti anticorpi contro l’IMP, o contro qualche eccipiente dell’IMP.
    • Qualsiasi condizione che potrebbe interferire sul giudizio dell’IMP o su una soddisfacente conduzione dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    PK of i.v. administration of study medication at steady state under normalised activity of C1-INH.
    determinazione farmacocinetica del principio attivo somministrato e.v. allo stato stabile riferito alla normale attività del C1-inibitore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 9 of the study.
    Settimana 9 dello studio.
    E.5.2Secondary end point(s)
    Safety of i.v. administration of study medication at high doses.
    Sicurezza della somministrazione e.v. del principio attivo ad alte dosi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 9 of the study.
    Settimana 9 dello studio.
    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 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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 2
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    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)
    To be followed-up according to the routine GCP.
    Rientrare in programma terapeutico e diagnostico secondo le regole GCP.
    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 Decision2013-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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