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    Clinical Trial Results:
    A multicenter, open-label study to collect the safety information of sacubitril/valsartan in Japanese pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed CLCZ696B2319E1 study

    Summary
    EudraCT number
    		 2023-001004-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2025
    First version publication date
    12 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLCZ696B2319E2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06149104
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Novartis Pharma AG, Clinical Disclosure Office, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Novartis Pharma AG, Clinical Disclosure Office, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To collect additional safety information of sacubitril/valsartan in Japanese patients after long-term treatment of sacubitril/valsartan in CLCZ696B2319E1 study.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    7
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 6 investigative sites in Japan.

    Pre-assignment
    Screening details
    		 All consenting participants were assessed for eligibility into this study at the first visit (Visit Day 1) and the study medication was initiated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Sacubitril/Valsartan
    Arm description
    		 The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. All participants had a target dose of 3.1 mg/kg bid. If a participant was unable to tolerate up-titration to a higher sacubitril/valsartan dose level or at the discretion of the Investigator, participants could be maintained on lower dose levels of sacubitril/valsartan.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sacubitril/Valsartan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.

    Investigational medicinal product name
    Sacubitril/Valsartan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.

    Investigational medicinal product name
    Sacubitril/Valsartan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator.

    Number of subjects in period 1
    		Sacubitril/Valsartan
    Started
    8
    Completed
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sacubitril/Valsartan
    Reporting group description
    		 The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. All participants had a target dose of 3.1 mg/kg bid. If a participant was unable to tolerate up-titration to a higher sacubitril/valsartan dose level or at the discretion of the Investigator, participants could be maintained on lower dose levels of sacubitril/valsartan.

    Reporting group values
    		 Sacubitril/Valsartan Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 7 7
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.75 ( 4.234 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 6 6
        Male
    		 2 2
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Sacubitril/Valsartan
    Reporting group description
    		 The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. All participants had a target dose of 3.1 mg/kg bid. If a participant was unable to tolerate up-titration to a higher sacubitril/valsartan dose level or at the discretion of the Investigator, participants could be maintained on lower dose levels of sacubitril/valsartan.

    Primary: Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs)

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    End point title
    		 Number of participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) [1]
    End point description
    Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
    End point type
    Primary
    End point timeframe
    Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: only analyzed descriptively.
    End point values
    		 Sacubitril/Valsartan
    Number of subjects analysed
    8
    Units: participants
        Adverse Events
    6
        Serious Adverse Events
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Sacubitril/Valsartan
    Reporting group description
    		 Sacubitril/Valsartan

    Reporting group title
    All Patients
    Reporting group description
    		 All Patients

    Serious adverse events
    		 Sacubitril/Valsartan All Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sacubitril/Valsartan All Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    6 / 8 (75.00%)
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    3
    3
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Muscle tightness
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 8 (25.00%)
         occurrences all number
    5
    5
    Otitis media
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Streptococcal infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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