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    Summary
    EudraCT Number:2011-004145-41
    Sponsor's Protocol Code Number:8638
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-01-23
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2011-004145-41
    A.3Full title of the trial
    Efficacy and safety of acebutolol versus propranolol in the proliferative phase of infantile hemangiomas
    Efficacité et tolérance de l'acébutolol versus propranolol sur la phase proliférative des hémangiomes infantiles
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of acebutolol versus propranolol in the proliferative phase of infantile hemangiomas
    Efficacité et tolérance de l'acébutolol versus propranolol sur la phase proliférative des hémangiomes infantiles
    A.4.1Sponsor's protocol code number8638
    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 SponsorUH Montpellier
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHealth Ministry
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch and Innovation Department
    B.5.2Functional name of contact pointDRC
    B.5.3 Address:
    B.5.3.1Street Address39 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier cedex 5
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number33467339833
    B.5.5Fax number33467339172
    B.5.6E-mailsec-recherche@chu-montpellier.fr
    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 Yes
    D.2.1.1.1Trade name acebutolol
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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 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 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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name syprol
    D.2.1.1.2Name of the Marketing Authorisation holderRosemont Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infant 0 to 6 months
    Non-serious hemangioma
    Nourrisson de 0 à 6 mois
    Hémangiome sans critère de gravité
    E.1.1.1Medical condition in easily understood language
    Infant 0 to 6 months
    Non-serious hemangioma
    Nourrisson de 0 à 6 mois
    Hémangiome sans critère de gravité
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019400
    E.1.2Term Hemangioma of skin and subcutaneous tissue
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to evaluate the clinical efficacy and safety of a three months treatment by acebutolol (10mg/kg/j) compared to propranolol (3mg/kg/j) on the proliferative phase of non-severe infantile hemangioma no requiring corticosteroids
    L'objectif principal de l'étude est d'évaluer l'efficacité clinique et la tolérance à 3 mois de l'acébutolol à (10mg/kg/j) sur la phase proliférative de l'hémangiome infantile non grave du nourrisson ne relevant pas d'une corticothérapie, par comparaison au propranolol (3mg/kg/j)
    E.2.2Secondary objectives of the trial
    -Compare the adverse effects of treatments
    -Compare the effectiveness of treatments on the proliferation of hemangioma from Doppler measurements
    - Study the evolution of the clinical efficacy of acebutolol and propranolol
    -Comparer les effets indésirables des traitements administrés
    -Comparer l’efficacité des traitements de l'étude sur la prolifération de l’hémangiome à partir de mesures en écho-doppler
    - Evaluer l'évolution de l'efficacité clinique de l'acébutolol et du propranolol avec le temps
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Infant 0 to 6 months
    hemangioma with the following characteristics: subcutaneous and / or skin, minimum diameter of 1.5 cm for the face and 5 cm outside the face or 3 cm if ulcerated, without functional impairment or requiring treatment with steroid
    Nourrisson de 0 à 6 mois
    Présentant un hémangiome ayant les caractéristiques suivantes : sous-cutanée et/ou cutané, diamètre minimal de 1,5 cm pour le visage et de 5 cm en dehors du visage ou 3 cm si ulcéré, sans retentissement fonctionnel ou vital nécessitant un traitement par corticoïde
    E.4Principal exclusion criteria
    -indication for a treatment with corticosteroids for an indication other than the hemangioma
    -indication for a Beta-blocker therapy for an indication other than the hemangioma
    -any contre indication to the administration of propranolol or acebutolol
    -Indication de traitement par corticothérapie pour une indication autre que l'hémangiome
    -Indication de traitement par bétabloquant pour une indication autre que l'hémangiome
    -Nourrisson présentant des contre-indications à l'administration d'acébutolol ou de propranolol


    E.5 End points
    E.5.1Primary end point(s)
    Reducing the volume of the hemangioma in 90 days. The volume of the hemangioma will be evaluated using a visual analog scale on standardized photographs.
    Régression du volume de l'hémangiome à 90 jours. Le volume de l'hémangiome sera évalué à l'aide d'une échelle visuelle analogique sur des photos standardisées.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each patient wil attend a total of 5 scheduled visits (day 1, day 7, day 30, day 60, day 90). Safety will be assess at each visit.
    Chaque patient effectuera un total de 5 visites (j1, j7, j30, j60 et j90). La tolérance sera évaluée à chaque visite.
    E.5.2Secondary end point(s)
    Evaluation of tolerance, measuring the thickness of the hemangioma by Doppler in a standardized manner (reference constant), measurement of vascularization (number of vaisseaux/cm2), Index of resistance and echogenicity.
    Evaluation de la tolérance, mesure de l'épaisseur de l'hémangiome par écho-doppler de manière standardisée (repère constant), mesure de la vascularisation (nombre de vaisseaux/cm2), Index de résistance et échogénicité.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each patient wil attend a total of 5 scheduled visits (day 1, day 7, day 30, day 60, day 90). Safety will be assess at each visit.
    Chaque patient effectuera un total de 5 visites (j1, j7, j30, j60 et j90). La tolérance sera évaluée à chaque visite.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 200
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 100
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 100
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state200
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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