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    Summary
    EudraCT Number:2013-003458-26
    Sponsor's Protocol Code Number:CSLCT-HDL-12-77
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003458-26
    A.3Full title of the trial
    A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Acute Myocardial Infarction
    Studio di Fase 2b, multicentrico, randomizzato, controllato con placebo, a dose variabile per studiare la sicurezza e la tollerabilità della somministrazione di dosi multiple di CSL112 in soggetti con infarto miocardico acuto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b study of CSL112 in subjects with acute myocardial infarction.
    Studio di Fase 2b di CSL112 in soggetti con infarto miocardico acuto.
    A.4.1Sponsor's protocol code numberCSLCT-HDL-12-77
    A.5.4Other Identifiers
    Name:IND NumberNumber:14849
    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 SponsorCSL Behring LLC
    B.1.3.4CountryUnited States
    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 supportCSL Behring LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring
    B.5.2Functional name of contact pointClin.Trial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street Address1020 First Avenue
    B.5.3.2Town/ cityKing of Prussia
    B.5.3.3Post codePA 19406
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@cslbehring.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 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 nameCSL112
    D.3.2Product code CSL112
    D.3.4Pharmaceutical form Lyophilisate for 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 INN-
    D.3.9.1CAS number 1361928-49-5
    D.3.9.2Current sponsor codeCSL112
    D.3.9.3Other descriptive nameAPOLIPOPROTEIN A-I, HUMAN
    D.3.9.4EV Substance CodeSUB88507
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 nameCSL112
    D.3.2Product code CSL112
    D.3.4Pharmaceutical form Lyophilisate for 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 INN-
    D.3.9.1CAS number 1361928-49-5
    D.3.9.2Current sponsor codeCSL112
    D.3.9.3Other descriptive nameAPOLIPOPROTEIN A-I, HUMAN
    D.3.9.4EV Substance CodeSUB88507
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myocardial Infarction
    Infarto Miocardico Acuto
    E.1.1.1Medical condition in easily understood language
    Heart attack
    Infarto
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 hepatic and renal safety of multiple dose administration of two dose levels of CSL112 (low dose [2 g] or high dose [6 g]) compared with placebo in subjects with acute myocardial infarction.
    Valutare la sicurezza epatica e renale della somministrazione di dosi multiple in due livelli posologici di CSL112 (a basso dosaggio [2 g] o ad alto dosaggio [6 g]) rispetto a placebo nei soggetti con Infarto Miocardico Acuto.
    E.2.2Secondary objectives of the trial
    To examine the effect of CSL112 on the time-to-first occurrence of major adverse cardiovascular events (MACE), to characterize the safety and tolerability of CSL112, and to characterize the pharmacokinetics (PK) of CSL112 after multiple dose administration.
    esame dell’effetto di CSL112 sul tempo alla prima manifestazione di eventi avversi cardiovascolari maggiori (major adverse cardiovascular events, MACE), per caratterizzare la sicurezza e la tollerabilità di CSL112 nonché la farmacocinetica (PK) di CSL112 dopo la somministrazione di dosi multiple.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK/PD substudy to characterize the pharmacokinetics and pharmacodynamics of CSL112 after multiple dose administration
    sottostudio PK/PD per caratterizzare la sicurezza e la tollerabilità di CSL112 nonché la farmacocinetica (PK) di CSL112 dopo la somministrazione di dosi multiple.
    E.3Principal inclusion criteria
    • Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last four days.
    1. Detection of a rise and/or fall cardiac troponin I or T with at least one
    value above the 99th percentile upper reference limit.
    AND,
    2. Any one or more of the following:
    a. Symptoms of ischemia
    b. New (or presumably new) significant ST/T wave changes or
    left bundle-branch block (LBBB)
    c. Development of pathological Q waves on ECG
    d. Imaging evidence of new loss of viable myocardium or
    regional wall motion abnormality
    e. Identification of intracoronary thrombus by angiography
    Uomini o donne di almeno 18 anni di età con evidenza di necrosi miocardica in un contesto clinico coerente con un IMA di tipo I (spontaneo), secondo le seguenti definizioni:
    1. Rilevamento di un aumento e/o riduzione della troponina cardiaca I o T con almeno un valore superiore al limite superiore di riferimento del 99o percentile.
    E
    2. una o più delle seguenti condizioni:
    a.Sintomi di ischemia.
    b.Nuove (o presumibilmente nuove) modifiche significative dell’onda ST/T o blocco di branca sinistra (BBS).
    c.Sviluppo di onde patologiche Q sull’ECG.
    d.Evidenza nella diagnostica per immagini di nuova perdita di miocardio vitale o di anomalia del movimento della parete regionale.
    e.Identificazione di trombo intracoronarico mediante angiografia.
    E.4Principal exclusion criteria
    • Ongoing hemodynamic instability
    • Evidence of hepatobiliary disease
    • Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis
    • Evidence of unstable renal function
    • History of acute kidney injury after previous exposure to an intravenous contrast agent.
    • Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
    • Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study
    • instabilità emodinamica in corso
    • Evidenza di malattia epatobiliare
    • Evidenza di malattia renale cronica (CKD) (fase III, IV o V), definita
    come moderata o grave insufficienza renale o se il soggetto è in dialisi
    • Prove di funzionalità renale instabile
    • Storia di danno renale acuto dopo una precedente esposizione ad un
    agente di contrasto per via endovenosa.
    • Storia nota di allergie, ipersensibilità o carenze a CSL112
    o uno dei suoi componenti
    • Altra grave condizione di comorbidità, farmaci concomitanti, o altro problema che rende il soggetto non idoneo per la partecipazione allo studio
    E.5 End points
    E.5.1Primary end point(s)
    - Clinically important change in drug-induced liver injury defined as a change (from baseline) in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or a change in total bilirubin greater than 2 times ULN, that is confirmed as determined upon repeat measurement.

    - Clinically important change in renal status defined as a serum creatinine (Cr) increase to ≥ 1.5 x the baseline value, that is confirmed as determined upon repeat measurement or the need for renal replacement therapy.
    - Una variazione clinicamente rilevante della lesione epatica indotta dal farmaco definita come variazione (dal basale) dell’alanina amino transferasi (ALT) maggiore di 3 volte il limite superiore della norma (Upper Limit of Normal, ULN), OPPURE una variazione della bilirubina totale maggiore di 2 volte ULN, che si conferma per come determinato alla ripetizione della misurazione.
    - Una variazione clinicamente rilevante nello stato renale definita come aumento della creatinina sierica a ≥ 1,5 x il valore basale che si conferma per come determinato alla ripetizione della misurazione o per la necessità di dover ricorrere a terapia sostitutiva renale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (before 1st infusion) to Day 29.
    dal basale (prima della prima infusione) al giorno 29.
    E.5.2Secondary end point(s)
    1. The time-to-first occurrence of a major adverse cardiovascular event (MACE). MACE includes: cardiovascular death, MI, ischemic stroke and hospitalization for unstable angina.
    2. Pharmacokinetic profile (baseline-corrected plasma concentrations) of apolipoprotein A-I (apoA-I) and phosphatidylcholine (PC)
    3. Plasma apoA-I and PC Cmax
    4. Plasma apoA-I and PC Tmax
    5. Plasma apoA-I and PC area under the curve (AUC)
    6. Plasma apoA-I and PC t1/2
    7. Plasma apoA-I and PC Clearance
    8. Plasma apoA-I and PC Volume of distribution at steady state
    9. The number of subjects with study-drug-related AEs
    10. Overall AEs: total number of subjects with any AE
    11. Bleeding events: number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)
    12. Immunogenic potential of CSL112: number of subjects with serum antibodies to CSL112
    13. Change from baseline in serology: assessments (i.e., evidence of seroconversion or infection) will be conducted for hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) 1/2, parvovirus B19
    14. Change from baseline in nucleic acid testing : assessments (i.e., evidence of seroconversion or infection) will be conducted for HAV, HBV, HCV, HIV 1/2, parvovirus B19
    1. Il tempo alla prima manifestazione di MACE (major adverse cardiovascular event). MACE include: Decesso cardiovascolare, Infarto miocardico (IM), Ictus ischemico e Ricovero dovuto ad angina instabile
    2. Profilo farmacocinetico (concentrazioni plasmatiche corrette al basale) di apolipoproteina A-I (apoA-I) e fosfatidilcolina (PC)
    3. apoA-I del plasma e PC Cmax
    4. apoA-I del plasma e PC Tmax
    5. apoA-I del plasma e PC area sotto la curva (AUC)
    6. apoA-I del plasma e and PC t1/2
    7. apoA-I del plasma e PC Clearance
    8. apoA-I del plasma e PC Volume di distribuzione allo stato stazionario
    9. Numero di soggetti con eventi avversi (EA) correlate al farmaco di studio
    10. Eventi avversi complessivi : numero totale di pazienti con EA.
    11. La manifestazione di eventi emorragici secondo quanto definito dai criteri del Bleeding Academic Research Consortium (BARC) (Mehran et al., 2011).
    12. valutazione del potenziale immunogenico di CSL112: numero di soggetti con anticorpi serici di CSL112
    13. Valutazione delle variazioni dal basale della sierologia: valutazioni(es. evidenza di sieroconversione o di infezione) per virus dell’epatite A (HAV), virus dell’epatite B (HBV), virus dell’epatite C (HCV), virus dell’immunodeficienza umana (HIV) 1/2, parvovirus B19.
    14. Valutazione delle variazioni dal basale delle tecniche di amplificazione degli acidi nucleici: (es. evidenza di sieroconversione o di infezione) per virus dell’epatite A (HAV), virus dell’epatite B (HBV), virus dell’epatite C (HCV), virus dell’immunodeficienza umana (HIV) 1/2, parvovirus B19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From the start of the first infusion up to 112 days after infusion
    2.- 8.: Before and after the first and last infusions
    9.- 11.: From the start of the infusion to the subject's end of study visit, up to approximately Day 382.
    12.- 14.: Before infusion, and up to approximately Day 112
    1. dall’inizio della prima infusione fino al giorno 112 dopo l’infusione.
    2.- 8.: prima e dopo la prima e l’ultima infusione
    9.- 11.: dall’inizio dell’infusione fino alla visita di fine studio del soggetto, approssimativamente giorno 382.
    12.- 14.: prima dell’infusione e fino a circa il giorno 112
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Denmark
    France
    Italy
    Austria
    Netherlands
    Australia
    Czech Republic
    Germany
    Hungary
    Spain
    Israel
    Poland
    United Kingdom
    United States
    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
    LVLS
    LVLS
    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 months10
    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 months10
    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 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: 780
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 420
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 966
    F.4.2.2In the whole clinical trial 1200
    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)
    Standard of care
    Terapia Standard
    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 Decision2014-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
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