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    Summary
    EudraCT Number:2017-004399-68
    Sponsor's Protocol Code Number:1925-201-008
    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:2021-01-27
    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 number2017-004399-68
    A.3Full title of the trial
    A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN 151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery
    Studio di fase 2 multicentrico, randomizzato, in doppio cieco, controllato verso placebo, di definizione della dose, volto a valutare l'efficacia e la sicurezza di iniezioni della tossina botulinica di tipo A (AGN-151607) nei cuscinetti adiposi epicardici per la prevenzione della fibrillazione atriale postoperatoria in pazienti sottoposti a cardiochirurgia a torace aperto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Botulinum toxin type A (AGN-151607) for the prevention of post operative atrial fibrillation in patients undergoing open-chest cardiac surgery
    Tossina botulinica di tipo A (AGN-151607) per la prevenzione della fibrillazione atriale postoperatoria in pazienti sottoposti a cardiochirurgia a torace aperto
    A.3.2Name or abbreviated title of the trial where available
    Botulinum toxin type A (AGN-151607) for the prevention of post operative atrial fibrillation in pati
    Tossina botulinica di tipo A (AGN-151607) per la prevenzione della fibrillazione atriale postoperato
    A.4.1Sponsor's protocol code number1925-201-008
    A.5.4Other Identifiers
    Name:IND numberNumber:135000
    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 SponsorALLERGAN LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street AddressGround Floor, Marlow International, Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailML-CTRG@Allergan.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 nameComplesso della neurotossina di Clostridium botulinum di tipo A (BoNT/A)
    D.3.2Product code [AGN-151607]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1883793-14-3
    D.3.9.2Current sponsor codeAGN-151607
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM
    D.3.9.4EV Substance CodeSUB130769
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 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 No
    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 nameComplesso della neurotossina di Clostridium botulinum di tipo A (BoNT/A)
    D.3.2Product code [AGN-151607]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1883793-14-3
    D.3.9.2Current sponsor codeAGN-151607
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM
    D.3.9.4EV Substance CodeSUB130769
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 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 No
    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 placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative atrial fibrillation (POAF)
    Fibrillazione atriale postoperatoria
    E.1.1.1Medical condition in easily understood language
    Prevention of post-operative atrial fibrillation
    Prevenzione della fibrillazione atriale postoperatoria
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    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 compare the efficacy of AGN-151607 with placebo to prevent post-operative atrial fibrillation (POAF) in participants who are undergoing open chest cardiac surgery
    Confrontare l'efficacia di AGN-151607 con il placebo in termini di prevenzione della fibrillazione atriale postoperatoria (POAF) nei partecipanti sottoposti a chirurgia cardiaca a torace aperto
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of AGN-151607 with placebo to reduce AF burden in participants who are undergoing open-chest cardiac surgery
    - To compare the efficacy of AGN-151607 with placebo to prevent POAF using alternative definitions for AF in participants who are undergoing open-chest cardiac surgery
    - To compare the safety of AGN-151607 with placebo in participants undergoing open-chest cardiac surgery
    - Confrontare l'efficacia di AGN-151607 con il placebo in termini di riduzione del burden della FA nei partecipanti sottoposti a chirurgia cardiaca a torace aperto
    - Confrontare l'efficacia di AGN-151607 con il placebo in termini di prevenzione della POAF utilizzando definizioni alternative di FA nei partecipanti sottoposti a chirurgia cardiaca a torace aperto
    - Confrontare la sicurezza di AGN-151607 con il placebo nei partecipanti sottoposti a chirurgia cardiaca a torace aperto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 55 to 90 years of age, inclusive, at the time of signing the informed consent;
    - scheduled to undergo open-chest cardiac surgery (includes: coronary artery bypass graft [CABG] and/or valve repair/replacement);
    - in sinus rhythm for the last 48 hours prior to surgery (prior history of paroxysmal AF is acceptable);
    - willing to wear an electrocardiogram (ECG) patch for 30 days post-surgery and for 7 days after each study visit.
    - da 55 a 90 anni (inclusi) al momento della sottoscrizione del consenso informato;
    - intervento chirurgico cardiaco a torace aperto programmato (tra cui: innesto di bypass aortocoronarico [CABG] e/o riparazione/sostituzione della valvola);
    - in ritmo sinusale per le ultime 48 ore prima dell'intervento (è accettabile che il soggetto abbia avuto pregressi di FA parossistica);
    - disposto/a a indossare un cerotto elettrocardiografico (ECG) per 30 giorni dopo l'intervento chirurgico e per 7 giorni dopo ogni visita dello studio
    E.4Principal exclusion criteria
    - any medical condition that may put the participant at increased risk with exposure to botulinum toxin type A, including diagnosed muscular dystrophy (eg, Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function;
    - participants with presence or history of any of the following within 3 months prior to the Day 1 visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment: aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease or otherwise compromised respiratory function;
    - permanent/persistent AF;
    - has a known allergy or sensitivity to any botulinum toxin type A preparation;
    - has a known allergy or sensitivity to medical adhesive (eg, ECG patch adhesive; hydrogel based adhesive);
    - severe (> 55mm) atrial enlargement;
    - left ventricular ejection fraction (LVEF) < 25%;
    - presence or history of symptomatic atrioventricular block > 1st degree within the last 30 days;
    - prior or concomitant therapy with Class I or III antiarrhythmic drugs unless proper washout was documented;
    - botulinum toxin type A (of any serotype) use within 6 months of randomization;
    - has been immunized for any botulinum toxin type A serotype as determined by participant medical history;
    - preoperative need for inotropes/vasopressors or intra-aortic balloon pump;
    - prior cardiac surgery;
    - history of ablation for AF;
    - planned ablation procedure for AF at the time of surgery;
    - emergency surgery;
    - impaired prognosis defined as EuroSCORE II greater than 7% perioperative mortality.
    - qualsiasi condizione medica che possa porre il/la partecipante a un rischio maggiore con l'esposizione alla tossina botulinica di tipo A, inclusa una diagnosi di distrofia muscolare (es. distrofia muscolare di Duchenne), miastenia gravis, sindrome di Eaton-Lambert, sclerosi laterale amiotrofica, malattia mitocondriale o qualsiasi altra malattia significativa che possa interferire con la funzionalità neuromuscolare;
    - partecipanti con presenza o anamnesi di una delle seguenti patologie nei 3 mesi antecedenti la visita del Giorno 1 che potrebbe indicare, secondo il giudizio clinico dello sperimentatore, uno stato respiratorio vulnerabile: polmonite da aspirazione, infezioni delle vie respiratorie inferiori, asma non controllata, broncopneumopatia cronica ostruttiva grave o comunque compromissione della funzionalità respiratoria;
    - FA permanente/persistente;
    - allergia o sensibilità nota a qualsiasi preparato contenente tossina botulinica di tipo A;
    - allergia o sensibilità nota all'adesivo medico (es. cerotto adesivo dell'ECG; adesivo a base di idrogel);
    - ingrandimento atriale grave (> 55 mm);
    - frazione di eiezione ventricolare sinistra (LVEF) < 25%;
    - presenza o pregressi di blocco atrioventricolare sintomatico superiore al 1° grado negli ultimi 30 giorni;
    - terapia precedente o concomitante con farmaci antiaritmici di Classe I o III, a meno che non sia stato documentato un adeguato wash out;
    - uso di tossina botulinica di tipo A (di qualsiasi sierotipo) entro 6 mesi dalla randomizzazione;
    - immunizzazione a qualsiasi sierotipo di tossina botulinica di tipo A che si evince dall'anamnesi medica del/della partecipante;
    - necessità preoperatoria di inotropi/vasopressori o pompa intra-aortica a palloncino;
    - intervento chirurgico cardiaco precedente;
    - anamnesi di ablazione per FA;
    - c'è in programma una procedura di ablazione per la FA al momento dell'intervento chirurgico;
    - intervento chirurgico d'urgenza;
    - prognosi compromessa definita da un punteggio EuroSCORE II superiore al 7% di mortalità perioperatoria.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode = 30 seconds during the first 30 days post surgery
    Percentuale di partecipanti con almeno 1 episodio di fibrillazione atriale (FA) continua = 30 secondi durante i primi 30 giorni dopo l'intervento chirurgico
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within the first 30 days post surgery
    Entro i primi 30 giorni dopo l'intervento chirurgico
    E.5.2Secondary end point(s)
    - Percentage of time spent in AF (AF burden) during the first 30 days post surgery
    - Percentage of participants with at least 1 event of symptomatic AF during the first 30 days post surgery
    - Time to first occurrence of AF during the first 30 days post surgery
    - Percentage of participants with at least 1 continuous AF episode = 2 minutes during the first 30 days post-surgery
    - Percentage of participants with at least 1 continuous AF episode = 5 minutes during the first 30 days post-surgery
    - Percentage of participants with at least 1 continuous AF episode = 30 minutes during the first 30 days post-surgery
    - Percentage of participants with at least 1 continuous AF episode = 1 hour during the first 30 days post surgery
    - Percentage of participants with at least 1 continuous AF episode = 4 hours during the first 30 days post surgery
    - Percentage of participants with at least 1 continuous AF episode = 24 hours during the first 30 days post surgery
    - Adverse events (AEs), physical examination, clinical laboratory tests, vital signs, electrocardiogram (ECGs), pulmonary function
    - Potential immunogenicity response
    - Percentuale del tempo trascorso in FA (burden della FA) durante i primi 30 giorni dopo l'intervento chirurgico
    - Percentuale di partecipanti con almeno 1 episodio di FA sintomatica durante i primi 30 giorni dopo l'intervento chirurgico
    - Tempo alla prima insorgenza di FA durante i primi 30 giorni dopo l'intervento chirurgico
    - Percentuale di partecipanti con almeno 1 episodio di FA continua = 2 minuti durante i primi 30 giorni dopo l'intervento chirurgico
    - Percentuale di partecipanti con almeno 1 episodio di FA continua = 5 minuti durante i primi 30 giorni dopo l'intervento chirurgico
    - Percentuale di partecipanti con almeno 1 episodio di FA continua = 30 minuti durante i primi 30 giorni dopo l'intervento chirurgico
    - Percentuale di partecipanti con almeno 1 episodio di FA continua = 1 ora durante i primi 30 giorni dopo l'intervento chirurgico
    - Percentuale di partecipanti con almeno 1 episodio di FA continua = 4 ore durante i primi 30 giorni dopo l'intervento chirurgico
    - Percentuale di partecipanti con almeno 1 episodio di FA continua = 24 ore durante i primi 30 giorni dopo l'intervento chirurgico
    - Eventi avversi (Adverse Event, AE), esame fisico, esami clinici di laboratorio, parametri vitali, elettrocardiogramma (ECG), funzionalità polmonare
    - Eventuale risposta immunogenica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within the first 30 days post surgery
    Entro i primi 30 giorni dopo l'intervento chirurgico
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Canada
    United States
    Austria
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    United Kingdom
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 330
    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
    nessuno
    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 Decision2019-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
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