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    Summary
    EudraCT Number:2016-001685-29
    Sponsor's Protocol Code Number:CV013011
    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:2021-05-25
    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 number2016-001685-29
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function
    Studio di Fase 2b multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, dose ranging sulla sicurezza e l’efficacia delle infusioni per via endovenosa continue per 48 ore di BMS-986231 in pazienti ricoverati con insufficienza cardiaca e funzione sistolica ridotta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study at different study sites testing the safety and effectiveness of a drug called BMS-986231 in the form of Intravenous Infusions for a duration of 48 hours in hospitalized patients whose heart is unable to pump sufficiently to maintain the blood flow their body needs to function well.
    Studio internazionale presso diversi centri per testare la sicurezza e l'efficacia di un farmaco denominato BMS-986231 in forma di infusioni endovenose per una durata di 48 ore in pazienti ricoverati in ospedale il cui cuore non è in grado di pompare a sufficienza per mantenere il flusso sanguigno necessario all'organismo per funzionare adeguatamente.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCV013011
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1181-9195
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number000000000000000
    B.5.5Fax number00000000000000
    B.5.6E-mailclinical.trials@bms.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 nameHNO donor
    D.3.2Product code [BMS-986231]
    D.3.4Pharmaceutical form Powder 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 INNHNO
    D.3.9.1CAS number 1620330-72-4
    D.3.9.2Current sponsor codeCV013-011
    D.3.9.4EV Substance CodeSUB182812
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboConcentrate for solution for 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
    Heart failure and impaired systolic function
    Insufficienza cardiaca e funzionalità sistolica compromessa
    E.1.1.1Medical condition in easily understood language
    Inability of the earth to pump sufficiently to maintain blood flow to meet the body's needs
    Il cuore non riesce a pompare un flusso di sangue sufficiente a portare avanti le funzioni vitali
    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 LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10074631
    E.1.2Term Systolic heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the effects of various doses of BMS-986231 compared to placebo on clinically relevant hypotension (defined by SBP<90 mm Hg or symptoms of hypotension)
    L'obiettivo primario è valutare gli effetti di diverse dosi di BMS-986231 messo a confronto con placebo nell'ipotensione clinicamente rilevante (definita da SBP<90 mmHg o da sintomi di ipotensione)
    E.2.2Secondary objectives of the trial
    Assess the effect of BMS-986231 on NT-proBNP
    Assess the effect of BMS-986231 on patient-reported resting dyspnea as measured by the 11-point Numerical Rating Scale (NRS)
    - Valutare l'effetto di BMS-986231 su NT-proBNP
    - Valutare l'effetto di BMS-986231 sulla dispnea a riposo riferita dal paziente, misurata con la scala numerica di valutazione (NRS) a 11 punti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Written Informed Consent
    a) Subjects will be required to provide a written informed consent
    2. Target Population
    b) Subjects being hospitalized for ADHF
    c) Have had at least 1 administration of at least 40 mg furosemide
    intravenous, or equivalent (e.g 40 mg furosemide equivalent to 20 mg
    torsemide or to 1 mg bumetanide) for the current ADHF episode
    d) Subject must be randomized and treated within 18 hours of first dose
    of intravenous diuretic
    e) Have dyspnea at rest or with minimal exertion after administration of
    at least 1 dose of intravenous diuretics. Subject must not be randomized
    within 2 hours after an IV bolus dose of intravenous diuretics, or within
    2 hours after the initiation or a dose increase of an IV diuretic
    administered by continuous infusion
    f) Have a history of heart failure and a left ventricular ejection fraction
    (LVEF) = 40%, as assessed by echocardiography, a multigated
    acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan
    Note: Ejection fraction documentation up to 18 months prior to screening may be used if there is no clinical expectation of improvement
    in ejection fraction in that timeframe (eg, the patient has not had
    biventricular pacing initiated during that period)
    g) Have at least 2 of the following at time of screening:
    i) evidence for pulmonary congestion on chest x-ray
    ii) rales by chest auscultation,
    iii) edema = 2+ on a 0 to 3+ scale (easily identifiable indentation, skin
    rebounds in 15-30 seconds)
    iv) presence of jugular venous distention
    h) Have an elevated NT-proBNP = 1600 pg/mL (189 pmol/L) or BNP =
    400 pg/mL (116 pmol/L) as determined at the local laboratory within 18
    hours prior to the start of study drug infusion
    For subjects with atrial fibrillation: NT-proBNP = 2400 pg/ml or BNP =¿
    600 pg/ml
    i) Body weight = 50 kg and < 140 kg at screening
    j) Subject Re-Screening: This study permits the re-screening of a subject
    that has discontinued the study as a screen failure (has not been
    randomized).
    3. Age and Reproductive Status
    a) Males and Females, at least age 18 (or age of majority)
    b) Women of childbearing potential (WOCBP) must have a negative
    serum or urine pregnancy test (minimum sensitivity 25 IU/L or
    equivalent units of HCG) within 18 hours prior to the start of study
    treatment
    c) Women must not be breastfeeding
    d) WOCBP must agree to follow instruction for methods of contraception
    for 32 days after discontinuation (duration of study drug plus 30 days
    duration of one ovulatory cycle)
    e) Males who are sexually active with WOCBP must agree to follow
    instructions for method(s) of contraception for 92 days after
    discontinuation (duration of study drug plus 90 days (duration of sperm
    turnover)
    f) Azoospermic males are exempt from contraceptive requirements.
    WOCBP who are continuously not heterosexually active are also exempt
    from contraceptive requirements, and still must undergo pregnancy
    testing as described in this section
    1. Consenso informato per iscritto firmato
    a) Ai soggetti sarà richiesto di fornire un consenso informato scritto
    2. Popolazione target
    b) Soggetti ricoverati per ADHF
    c) Avere ricevuto come minimo 1 somministrazione di almeno 40 mg di furosemide per via endovenosa o equivalente (ad esempio, 40 mg di furosemide equivalenti a 20 mg di torsemide o a 1 mg di bumetanide) per l'episodio di ADHF corrente
    d) I soggetti devono essere randomizzati e trattati entro 18 ore dalla prima dose di diuretico per via endovenosa
    e) Avere dispnea a riposo o con minimo sforzo dopo la somministrazione di almeno 1 dose di diuretici per via endovenosa. Il soggetto non deve essere randomizzato entro 2 ore dopo una dose in bolo EV di diuretici per via endovenosa oppure entro 2 ore dopo l'inizio o un aumento della dose di un diuretico
    EV somministrato mediante infusione continua
    f) Avere un’anamnesi di insufficienza cardiaca e una frazione di eiezione ventricolare sinistra (LVEF) = 40%, valutata mediante ecocardiografia, una scansione MUGA (acquisizione a gate multipli) o una scansione RMI (imaging a risonanza magnetica)
    Nota: la documentazione della frazione di eiezione fino a 18 mesi prima dello screening può essere utilizzata qualora non vi sia aspettativa clinica di miglioramento della frazione di eiezione durante tale periodo di tempo (ad esempio, il paziente non è stato sottoposto a stimolazione biventricolare durante questo periodo)
    g) Avere almeno 2 dei seguenti sintomi al momento dello screening:
    i) evidenza di congestione polmonare nella radiografia del torace
    ii) rantoli all'auscultazione del torace,
    iii) edema = 2+ su una scala da 0 a 3+ (fovea facilmente identificabile, con regressione della pelle
    in 15-30 secondi)
    iv) presenza di distensione della vena giugulare
    h) Avere un valore elevato di NT-proBNP = 1600 pg/mL (189 pmol/L) o BNP = 400 pg/mL (116 pmol/L) determinato nel laboratorio locale entro 18 ore prima dell'inizio dell'infusione del farmaco in studio
    Per i soggetti con fibrillazione atriale: NT-proBNP = 2400 pg/ml o BNP =¿600 pg/ml
    i) Peso corporeo = 50 kg e < 140 kg allo screening
    j) Ri-screening del soggetto: Questo studio consente il ri-screening di un soggetto che abbia interrotto lo studio per mancata qualificazione allo screening (non è stato randomizzato).
    3. Età e stato riproduttivo
    a) Uomini e donne di almeno 18 anni di età (o maggiorenni)
    b) le donne in età fertile (WOCBP) devono presentare un test di gravidanza su siero o urine negativo (sensibilità minima 25 IU/l o unità equivalenti di HCG) entro 18 ore prima dell'inizio della terapia con il trattamento in studio
    c) le donne non devono allattare
    d) Le donne in età fertile devono accettare di seguire le istruzioni relative ai metodi contraccettivi per 32 giorni dopo l'interruzione (durata del farmaco in studio più i 30 giorni della durata di un ciclo di ovulazione)
    e) Gli uomini sessualmente attivi con donne in età fertile devono accettare di seguire le istruzioni relative al/i metodo/i di contraccezione per 92 giorni dopo l'interruzione (durata del farmaco in studio più 90 giorni (durata del ciclo di ricambio dello sperma)
    f) Gli uomini azospermici sono esentati dai requisiti sulla contraccezione. Anche le donne in età fertile non continuativamente attive eterosessualmente sono esentate dai requisiti di contraccezione e comunque devono sottoporsi a test di gravidanza come descritto in questa sezione
    E.4Principal exclusion criteria
    1. Target Disease Exceptions
    a) Systolic blood pressure (SBP) < 105 mm Hg or > 160 mm Hg at
    screening
    b) Systolic blood pressure (SBP) < 105 mm Hg or > 160 mm Hg just
    prior to randomization
    c) Heart rate < 50 beats per minute (bpm) or > 130 bpm at screening
    d) Heart rate < 50 beats per minute (bpm) or > 130 bpm just prior to
    randomization
    e) Have a primary HF etiology attributable to either
    restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or
    uncorrected severe valvular disease as defined by AHA/ACC/ESC criteria
    Note: Functional mitral regurgitation, as well as restrictive mitral inflow
    pattern on echocardiography is not exclusionary
    f) Have a body temperature = 38.5°C (101.3°F) at any time from
    screening to randomization
    g) Have an active infection requiring IV anti-microbial treatment
    - Refer to the protocol
    1. Eccezioni relative alla malattia bersaglio
    a) Pressione arteriosa sistolica (SBP) < 105 mm Hg o > 160 mm Hg allo screening
    b) Pressione arteriosa sistolica (SBP) < 105 mm Hg o > 160 mm Hg poco prima della randomizzazione
    c) Frequenza cardiaca < 50 battiti al minuto (bpm) o > 130 bpm allo screening
    c) Frequenza cardiaca < 50 battiti al minuto (bpm) o > 130 bpm poco prima della randomizzazione
    e) Avere un'eziologia primaria di HF attribuibile a cardiomiopatia restrittiva/ostruttiva, ipertrofica idiopatica o patologia valvolare grave non corretta definita mediante criteri AHA/ACC/ESC
    Nota: il rigurgito mitralico funzionale e il pattern di inflow mitralico di tipo restrittivo nell'ecocardiografia non sono un fattore esclusorio
    f) Avere una temperatura corporea di = 38,5 °C (101,3 °F) in qualsiasi momento dallo screening alla randomizzazione
    g) Avere un'infezione attiva che richiede trattamento antimicrobico EV
    - Altri criteri di esclusione vedere protocollo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of clinically relevant hypotension, defined by SBP < 90 mm Hg (confirmed by a repeated value < 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion.
    L'endpoint primario è l'incidenza di ipotensione clinicamente rilevante, definita da SBP <90 mm Hg (confermata da un valore <90 mm Hg ripetuto) oppure da sintomi di ipotensione, fino a 6 ore dopo la fine dell'infusione del farmaco in studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 6 hours after the end of study drug infusion.
    Fino a 6 ore dopo la fine dell'infusione del farmaco in studio.
    E.5.2Secondary end point(s)
    - Change in NT-proBNP from baseline to Hour 24, 48, 72, 120 or
    discharge (whichever comes first), and at Day 32
    - Change in subject-reported resting dyspnea from baseline through
    Hour 72, as measured by the area under the curve (AUC) of the 11-point
    Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24,
    48, and 72 ; Change in NT-proBNP from baseline to Hour 24, 48, 72, 120 or discharge (whichever comes first), and at Day 32 - Change in subject-reported resting dyspnea from baseline through Hour 72, as measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72
    - Variazione nell'NT-proBNP dalla baseline a 24, 48, 72, 120 ore oppure alla dimissione, quale che sia l'evento che si verifica prima, e al Giorno 32
    - Variazione nella dispnea a riposo riferita dal soggetto dalla baseline a 72 ore, misurata dall'area sotto la curva (AUC) della scala numerica di valutazione (NRS) a 11 punti ottenuta alla baseline e a 6, 12, 24, 48 e 72 ore
    ; Variazione nell'NT-proBNP dalla baseline a 24, 48, 72, 120 ore oppure alla dimissione, quale che sia l'evento che si verifica prima, e al Giorno 32 - Variazione nella dispnea a riposo riferita dal soggetto dalla baseline a 72 ore, misurata dall'area sotto la curva (AUC) della scala numerica di valutazione (NRS) a 11 punti ottenuta alla baseline e a 6, 12, 24, 48 e 72 ore
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Hour 24, 48, 72, 120 or discharge (whichever comes first), and at Day
    32
    - baseline, and Hours 6, 12, 24, 48, and 72 ; - Hour 24, 48, 72, 120 or discharge (whichever comes first), and at Day 32 - baseline, and Hours 6, 12, 24, 48, and 72
    - 24, 48, 72, 120 ore oppure alla dimissione, quale che sia l'evento che si verifica prima, e al Giorno 32; - 24, 48, 72, 120 ore oppure alla dimissione, quale che sia l'evento che si verifica prima, e al Giorno 32
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Definizione della dose (dose ranging)
    Dose ranging
    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 trial5
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    France
    Germany
    Greece
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    Czechia
    Argentina
    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
    Last subject's final follow-up visit on Day 182, or the last subject's
    scheduled procedure shown in the Time & Events schedule.
    Ultima visita di follow-up finale del soggetto il Giorno 182 o ultima procedura programmata del soggetto indicata nel programma Tempistiche ed Eventi.
    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 months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 248
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 310
    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 end of the in-patient period, BMS will not continue to provide BMS supplied study drug to subjects/investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    Al termine del periodo di ricovero del paziente, BMS non continuerà a fornire il farmaco di studio f ai soggett/sperimentatori, salvo in caso di estensione dello studio decisa da BMS. Lo speimentatore deve assicurare che il soggetto riceva uno standard di cura appropriato per il trattamento della condizione oggetto dello studio.
    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 Decision2019-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
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