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    Summary
    EudraCT Number:2009-018102-22
    Sponsor's Protocol Code Number:V00400SB102
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-018102-22
    A.3Full title of the trial
    A multicentre, open-label, repeated-dose, pharmacokinetic study of Propranolol in infants treated for proliferating infantile hemangiomas (IHs) requiring systemic therapy.
    A.4.1Sponsor's protocol code numberV00400SB102
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE DERMATOLOGIE
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameV0400SB07
    D.3.2Product code V0400SB07
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROPRANOLOL HYDROCHLORIDE
    D.3.9.1CAS number 318-98-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Proliferating Infantile Hemangioma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10018814
    E.1.2Term Haemangioma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to characterise the pharmacokinetics of Propranolol at steady-state in infants during a treatment for proliferating infantile hemangiomas requiring systemic therapy.
    E.2.2Secondary objectives of the trial
    • To assess efficacy of Propranolol on the evolution of the target IH over 12 weeks.
    • To document the safety profile of Propranolol in the treatment of IH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible if he/she meets all of the following criteria:
    • Written informed consent(s) for study participation is obtained according to national regulations from the patient’s parent(s) or guardian(s) prior to performing any study procedures,
    • The patient is 35 to 150 days old, inclusive, at inclusion,
    • Proliferating IH (target hemangioma) requiring systemic therapy is present: function-threatening IH, IH in certain anatomic locations that often leave permanent scars or deformity, large facial IH, smaller IH in exposed areas, severe ulcerated IH, pedunculated IH,
    • Affiliated with, or beneficiary of the social security.
    E.4Principal exclusion criteria
    A patient will be ineligible if he/she meets any of the following criteria:
    • The patient has a medically unstable health status that may interfere with his/her ability to complete the study,
    • The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud’s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal’s angina; documented PHACES syndrome with central nervous system involvement,
    • The patient (and/or the mother if she is breastfeeding the patient) has received at least one of the following prohibited medications within 15 days of randomisation:
    o Anaesthetic agents (the exclusion period is shortened to 48 hours, if anaesthesia has been performed for diagnosis investigation (e.g. MRI…)
    o Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators (hydralazine hydrochloride…), clonidine…
    o Hypoglycaemic agents or drugs able to induce hypoglycaemia
    o Anti-ulcer drugs (cimetidine…)
    o Metoclopramide
    o Prostaglandin synthetase inhibitors
    o Sympathomimetic agents and parenteral adrenaline
    o Benzodiazepines
    o Neuroleptic drugs (chlorpromazine, sultopride hydrochloride…)
    o Other drugs: triptans, ergotamine, theophylline, warfarin, thyroxine, floctafenine,
    • The patient (and/or the mother if she is breastfeeding the patient) has received any treatment which could lead to induction or inhibition of hepatic microsomal enzymes within 2 months of randomisation,
    • The patient has previously been administered at least one of the following prohibited medications: systemic (oral, intra-venous or intra-muscular), intra-lesional or topical corticosteroids, imiquimod, vincristine, alfa-interferon, Propranolol or other beta-blockers,
    • The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy),
    • The patient’s mother has been breastfeeding the patient while she was also being treated with beta-blockers (including Propranolol ) or, she has been breastfeeding the patient within 15 days of randomisation while she was also being treated with systemic (oral, intra-venous or intra-muscular) corticosteroids, vincristine or alfa-interferon,
    • The patient is known to have a hypersensitivity to Propranolol or to any component of the investigational product and/or any other beta-blockers,
    • The patient has previously experienced an anaphylactic reaction,
    • The patient has a life-threatening IH,
    • Diagnosis of the soft tissue tumour as IH is not clinically certain, particularly in the case of sub-dermal lesions,
    • The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months),
    • LVEF (left ventricular systolic function) ≤ 40% and/or cardiomyopathy and/or hereditary arrhythmia disorder,
    • The patient is participating in another clinical study or the patient lives in the same household as an infant already participating in this or another study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary criterion: Pharmacokinetics
    The pharmacokinetic assessment will primarily evaluate at steady-state, the rate and extent of absorption, as well as the total plasma clearance of Propranolol in infants.
    According to their stratification group, pharmacokinetic sampling will be performed at 1 month or 3 months after the beginning of treatment.
    During the titration period, 2 micro-blood samples for Propranolol plasma level determination will be obtained at D7 and D14, respectively through puncture of a peripheral vein in the forearm after an appropriate local anaesthetic application.
    At steady-state, micro-blood samples for Propranolol plasma level determination will be drawn via a catheter after an appropriate local anaesthetic application. Six (6) micro-blood samples will be collected over a 9 hour-period: T0 (just before morning dosing, 12 hours after the previous evening administration) and 1h, 2h, 4h, 6h and 9h after the morning administration.
    Blood samples will be centrifuged; plasma will be separated and frozen at – 20°C until assay.
    Bioanalysis: Propranolol plasma concentrations will be quantified using a validated LC/MS-MS method
    The following pharmacokinetic parameters will be assessed for propranolol using a non-compartmental approach: Cmax, Tmax, AUCĪ„ and Cl/F.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 visit of the last patient
    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 months15
    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 months0
    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 Yes
    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) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 18
    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)
    Already provided in the protocol
    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 Decision2010-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-07
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