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    Clinical Trial Results:
    A multicentre, open-label study of propranolol in infants with proliferating infantile hemangioma requiring systemic therapy

    Summary
    EudraCT number
    		 2010-023488-16
    Trial protocol
    		 FR  
    Global end of trial date
    12 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2016
    First version publication date
    17 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V00400SB301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Dermatologie
    Sponsor organisation address
    45, Place Abel Gance, Boulogne, France, 92100
    Public contact
    Medical and/or Clinical Study Manager, Pierre Fabre Dermatologie, contact_essais_cliniques@pierre-fabre.com
    Scientific contact
    Medical and/or Clinical Study Manager, Pierre Fabre Dermatologie, contact_essais_cliniques@pierre-fabre.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study are to allow the use of propranolol with adequate conditions of administration and follow up in infants still requiring this systemic treatment (in the Investigator's opinion) after their participation to a previous trials. As requested in such conditions, the safety profile (included any potential long-term post-treatment impact) and the effect on the resolution of IH are documented.
    Protection of trial subjects
    Clinical (including respiratory rate and vital sign measurements) and paraclinical (lab tests (haematology, biochemistry, glycemia (pin-prick) and ECG) examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Apr 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 17 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    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
    		 -

    Pre-assignment
    Screening details
    		 French patients who has received study treatment in a previous studies and completed the corresponding end of study visit within the previous 6 months, and who has still required this systemic therapy in the investigator's opinion.

    Period 1
    Period 1 title
    24-week study treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Propranolol 2 mg/kg/day - 24 weeks
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propranolol hydrochloride oral solution
    Investigational medicinal product code
    V0400SB
    Other name
    Hemangiol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    D0: 1 mg/kg/day D7: increase to 2 mg/kg/day during 24 weeks

    Arm title
    		 Propranolol 3 mg/kg/day - 24 weeks
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propranolol hydrochloride oral solution
    Investigational medicinal product code
    V0400SB
    Other name
    Hemangiol
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    D0: 1 mg/kg/day D7: increase to 2 mg/kg/day D14: increase to 3 mg/kg/day during 24 weeks.

    Number of subjects in period 1
    		Propranolol 2 mg/kg/day - 24 weeks Propranolol 3 mg/kg/day - 24 weeks
    Started
    4
    7
    Completed
    4
    1
    Not completed
    0
    6
         Treatment unit
    -
    1
         'treatment effect/Improvement '
    -
    5
    Period 2
    Period 2 title
    72-week follow-up period (no study drug)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 72-week Follow-up period of 2 or 3mg/kg/day
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		72-week Follow-up period of 2 or 3mg/kg/day
    Started
    5
    Completed
    10
    Not completed
    1
         Lost to follow-up
    1
    Joined
    6
         Prematurely discontiued the treatment period
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    24-week study treatment period
    Reporting group description
    		 -

    Reporting group values
    		 24-week study treatment period Total
    Number of subjects
    		 11 11
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 11 11
    Age continuous
    Units: days
        arithmetic mean (full range (min-max))
    		 196 (101 to 397) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 1 1
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All included and treated patients.

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    11
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    11
    Age continuous
    Units: days
        arithmetic mean (full range (min-max))
    196 (101 to 397)
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    1

    End points

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    End points reporting groups
    Reporting group title
    Propranolol 2 mg/kg/day - 24 weeks
    Reporting group description
    		 -

    Reporting group title
    Propranolol 3 mg/kg/day - 24 weeks
    Reporting group description
    		 -
    Reporting group title
    72-week Follow-up period of 2 or 3mg/kg/day
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All included and treated patients.

    Primary: IH improvement

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    End point title
    		 IH improvement [1]
    End point description
    End point type
    Primary
    End point timeframe
    at each planned visit (11 visits)
    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: As a consequence of the low number of included patients (11 patients), no descriptive statistics were performed , only individual tabulated listings were provided.
    End point values
    		 Full analysis set
    Number of subjects analysed
    11
    Units: subject
        number (not applicable)
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Whole study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Study treatment period
    Reporting group description
    		 All treated subjects

    Reporting group title
    Long term follow-up period
    Reporting group description
    		 -

    Serious adverse events
    		 Study treatment period Long term follow-up period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Study treatment period Long term follow-up period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    11 / 11 (100.00%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 11 (18.18%)
         occurrences all number
    2
    2
    Ear and labyrinth disorders
    External ear inflammation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    Diarrhoea
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    vomiting
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Asthma
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Middle insomnia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 11 (45.45%)
    5 / 11 (45.45%)
         occurrences all number
    6
    13
    Bronchiolitis
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 11 (9.09%)
         occurrences all number
    3
    1
    Bronchitis
         subjects affected / exposed
    3 / 11 (27.27%)
    2 / 11 (18.18%)
         occurrences all number
    5
    3
    Gastroenteritis
         subjects affected / exposed
    3 / 11 (27.27%)
    3 / 11 (27.27%)
         occurrences all number
    5
    3
    Otitis media
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences all number
    1
    2
    Varicella
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    Viral infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    3
    Laryngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    2
    Folliculitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Tracheitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2011
    - Removal of one visit (no particular safety issue was expected at this visit), - Removal for need to collect blood in fasting state for screening laboratory tests, - change in the sponsor's contact for notification of SAEs, - change in the sponsor's personnel list.

    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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