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    Summary
    EudraCT Number:2011-003144-50
    Sponsor's Protocol Code Number:V00400GL2011A
    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:2011-09-20
    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 number2011-003144-50
    A.3Full title of the trial
    A randomised, double blind, controlled, multicentre study in infants with infantile hemangioma to compare propranolol gel to placebo
    Etude randomisée, multicentrique, contrôlée, en double aveugle, chez des nourrissons présentant un hémangiome infantile afin de comparer le propranolol sous forme de gel au placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in infants with infantile hemangioma to compare propranolol gel to placebo.
    Etude chez des nourrissons présentant un hémangiome infantile afin de comparer le propranolol sous forme de gel au placebo.
    A.4.1Sponsor's protocol code numberV00400GL2011A
    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 SponsorPierre Fabre Dermatologie, Represented by Institut de Recherche Pierre Fabre
    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 supportPIERRE FABRE DERMATOLOGIE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherche Pierre Fabre
    B.5.2Functional name of contact pointClinical Study Manager
    B.5.3 Address:
    B.5.3.1Street Address3, avenue Hubert Curien, BP 13562
    B.5.3.2Town/ cityTOULOUSE Cedex 1
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number33-(0) 5 34 50 62 16-
    B.5.5Fax number33-(0) 5 34 50 65 92-
    B.5.6E-mailgaelle.alcaraz@pierre-fabre.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.3.2Product code V0400GL01A
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPCutaneous 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.3.9.2Current sponsor codeV0400
    D.3.9.4EV Substance CodeSUB04091MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Proliferating localised uncomplicated infantile hemangioma not requiring systemic therapy
    Hémangiome Infantile prolifératif localisé non compliqué ne nécessitant pas de traitement systémique
    E.1.1.1Medical condition in easily understood language
    Proliferating localised uncomplicated infantile hemangioma
    Hémangiome infantile localisé prolifératif non compliqué
    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 14.0
    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
    To assess propranolol gel efficacy in terms of complete/nearly complete resolution of the Infantile Hemangioma at W12 compared to baseline.

    Evaluation de l’efficacité du gel propranolol en terme de disparition complète/presque complète de l’hémangiome infantile à S12 par rapport à l’inclusion.
    E.2.2Secondary objectives of the trial
    Efficacy objectives:
    To assess propranolol gel efficacy in terms of complete/nearly complete resolution of the IH at W4, W8 and Week 24 compared to baseline
    To evaluate the parent(s) or guardian(s) on-site qualitative assessments
    To assess the persistence of efficacy 12 weeksafter the end of treatment.

    Safety objective:
    To assess the safety profile and the local tolerance of the propranolol gel
    Objectifs d’efficacité :
    Évaluation de l’efficacité du gel propranolol en terme de disparition complète/presque complète de l’hémangiome infantile à S4, S8 et S24 par rapport à l’inclusion.
    Évaluations qualitatives sur site par le(s) parent(s) ou tuteur(s).
    Évaluation de la persistance de l’efficacité 12 semaines après la fin du traitement.

    Objectif de sécurité :
    Evaluation du profil de sécurité et de la tolérance locale du gel de propranolol.
    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 and the use of the patient’s images are obtained according to national regulations from the patient’s parent(s) or legal guardian(s) prior to performing any study procedures.
    • The patient is 35 to 150 days old inclusive, at inclusion.
    • Only one proliferating IH is present anywhere on the body except on the head, the neck, the hands and on the diaper area, with largest diameter ≥ 1cm and ≤ 3 cm.
    • If required by national regulations, patient registered with a social security or health insurance system and/or whose parent(s) or legal guardian(s) is (are) registered with a social security or health insurance system.
    Un patient est éligible s’il remplit tous les critères suivants :
    - Le consentement du(des) parent(s) du patient ou de leur(s) tuteur(s) pour la participation à l’étude et pour l’utilisation d’images des patients est obtenu conformément à la législation nationale avant toute procédure liée à l’étude.
    - Le patient est âgé de 35 à 150 jours inclus, à l’inclusion.
    - Le patient présente un seul HI situé n’importe où sur le corps excepté sur la tête, le cou, les mains et la zone des couches, et dont le plus grand diamètre est ≥ 1cm et ≤ 3 cm.
    - Si requis par la législation nationale, le patient bénéficie de la sécurité sociale ou d’une police d’assurance de santé ou dont le(s) parent(s) ou tuteur(s) bénéficie(nt) de la sécurité sociale ou d’une police d’assurance de santé.
    E.4Principal exclusion criteria
    A patient will be ineligible if he/she meets any of the following criteria:
    • The patient has got more than one IH with largest diameter ≥ 1cm
    • The patient has a medically unstable health status that may interfere with his/her ability to complete the study.
    • IH requires, according to Investigator’s judgment, a systemic treatment.
    • The patient is known to have one or more of the following medical conditions: bronchial asthma; bronchospasm; hypoglycaemia; untreated phaeochromocytoma; hypotension; second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia; severe peripheral arterial circulatory disturbances; Raynaud’s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal’s angina.
    • The patient has received at least one of the following prohibited medications within 14 days before randomisation:
    - Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators (hydralazine hydrochloride…), clonidine…
    - Hypoglycaemic agents or drugs able to induce hypoglycaemia.
    - Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose.
    - Sympathomimetic agents and parenteral adrenaline.

    • The patient has previously been administered systemic, intralesional or topical corticosteroids, vincristine, alfa-interferon, imiquimod, propranolol or other beta-blockers.
    • The patient has previously been administered treatment for IH or surgical and/or medical procedures (e.g. laser therapy) have been performed to treat the IH.
    • 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 14 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 and/or any other beta-blockers and/or any ingredient of the test product.
    • Patient with congenital hemangioma
    • Patient with ulcerated IH.
    • Patient with heart rate < 80 bpm at inclusion
    • Patient with blood pressure < 50/30 mmHg at inclusion
    • Patient with known renal impairment.
    • Patient with known cardiac conditions that may predispose to heart block.
    • The patient is participating in another clinical study or has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial.
    • The patient has sibling already participating to this clinical study
    • Parent(s) or legal guardian(s) who cannot be contacted by telephone in case of emergency.
    Un patient sera inéligible s’il remplit l’un des critères suivants :
    - Le patient a plus d’un hémangiome infantile (HI) dont le plus grand diamètre est ≥ 1cm.
    - Le patient a un état de santé médicalement instable, pouvant interférer avec sa capacité à poursuivre l’étude.
    - L’HI nécessite selon l’investigateur un traitement systémique.
    - Le patient a déjà eu une ou plusieurs des pathologies suivantes :
    Asthme bronchique, bronchospasmes, hypoglycémie, phéochromocytome non traité, hypotension, bloc cardiaque du second ou du troisième degré, arrêt cardio-respiratoire, acidose métabolique, bradycardie, troubles circulatoires périphériques artériels sévères, maladie de Raynaud, maladie de l’oreillette, défaillance cardiaque incontrôlée ou angor de Prinzmetal (syndrome coronarien aigu)
    - Le patient a reçu dans les 14 jours précédant la randomisation, au moins l’un des médicaments contre-indiqués suivants :
    • Traitements cardiovasculaires : anti-arythmiques, bloqueurs des canaux calciques, inhibiteurs de l’enzyme de conversion de l’angiotensine, agents inotropes, vasodilatateurs (hydralazine…), clonidine…
    • Agents hypoglycémiants ou médicaments induisant une hypoglycémie,
    • Anti-inflammatoires non stéroïdiens (AINS) à des doses anti inflammatoires,
    • Agents sympathomimétiques et adrénaline parentérale.
    - Le patient a précédemment été traité par des corticostéroïdes par voie systémique, intra-lésionnelle, locale, vincristine, interféron alpha, imiquimod, propranolol ou autres bêtabloquants.
    - Le patient a précédemment reçu un traitement pour l’HI ou a subi une intervention chirurgicale ou médicale (ex : thérapie laser) pour traiter l’HI.
    - La mère du patient a allaité le patient alors qu’elle était elle-même traitée par des bêtabloquants (y compris le propranolol) ou elle a allaité le patient dans les 14 jours précédents la randomisation alors qu’elle était traitée par des corticostéroïdes par voir systémique (orale, intra-veineuse, intra-musculaire), vincristine ou interféron alpha.
    - Le patient a déjà révélé une hypersensitivité au propranolol et/ou à un bêtabloquant et/ou à un composant du produit à l’étude.
    - Le patient présente un hémangiome congénital.
    - Le patient présente un hémangiome ulcéré.
    - Le patient présente une fréquence cardiaque < 80 bpm à l’inclusion.
    - Le patient présente une tension artérielle < 50/30 mm Hg à l’inclusion.
    - Le patient présente des troubles rénaux.
    - Le patient a déjà présenté un problème cardiaque prédisposant à des blocs de conduction cardiaque.
    - Le patient participe à une autre étude clinique ou a reçu un traitement avec un effet rémanent connu ou a subi une investigation risquant d’interférer avec cette étude clinique.
    - Le patient a un frère ou une sœur qui participe déjà à cette étude clinique.
    - Le(s) parent(s) ou tuteur(s) ne peu(ven)t pas être contacté(s) par téléphone en cas d’urgence.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy criterion is the evolution of IH from baseline to W12. The binary primary endpoint (success/failure) will be evaluated based on the intra-patient blinded centralised independent qualitative assessments of W12 photographs of the IH compared to baseline. A treatment success will be defined as a centralised assessment of complete/nearly complete resolution of the IH at W12 compared to baseline, where nearly complete resolution is defined as a minimal degree of telangiectasis, erythema, skin thickening, soft tissue swelling and/or distortion of anatomical landmarks.
    Le critère principal d’efficacité est l’évolution de l’HI à S12 par rapport à l’inclusion. Le critère binaire (succès/échec) sera évalué en aveugle par des lectures centralisées qualitatives indépendantes des photographies l’HI à S12 par rapport à l’inclusion. Un succès au traitement sera défini par une évaluation centralisée de la disparition complète/presque complète de l’HI à S12 par rapport à l’inclusion. Une disparition presque complète est définie par un degré minimal de télangectasies, érythème, épaississement de la peau, gonflement des tissus mou et/ou distorsion des points de repères anatomiques.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semaine 12
    E.5.2Secondary end point(s)
    Secondary efficacy criteria:
    • Centralised assessments of complete/nearly complete resolution of the IH at W4, W8 and W24 compared to baseline,.
    • Investigator on-site qualitative assessments
    - At each scheduled post-baseline visit compared to baseline categorical endpoints for complete/nearly complete resolution
    - At week 4, week 8, week 12 and week 24 compared to baseline categorical endpoints for IH evolution (4-points scale: complete resolution, improvement, stabilisation, worsening)
    - At each scheduled post-baseline visit compared to the previous schedule visit, categorical endpoints for IH evolution (4-points scale: complete resolution, improvement, stabilisation, worsening)
    • Parent(s) or guardian(s) on-site qualitative assessments at each scheduled post-baseline visit compared to the previous scheduled visit
    - Categorical endpoints for IH evolution (4-points scale: complete resolution, improvement, stabilisation, worsening)

    Persistence of efficacy criteria:
    • Persistence of complete/nearly complete resolution of the IH at W24 compared to W12 based on centralised assessments.
    • Investigator qualitative assessments by categorical endpoints for hemangioma evolution (4-points scale: complete resolution, improvement, stabilisation, worsening) at Week 24 (3 months after end of treatment).

    Safety criteria:
    • Safety endpoints will be based on the following evaluations:
    - Adverse events (AE)
    - Height, weight, head circumference, temperature, heart rate, blood pressure, respiratory rate, pulmonary auscultation, liver palpation and global physical examinations (all visits)
    • Local tolerability
    - Very good tolerance : no subjective sign or physical sign of local side effects
    - Good tolerance : transitory subjective signs, without physical sign or necessary modification of the frequency of product application
    - Poor tolerance : persisting subjective signs or physical signs of local side effects, leading to modification of the frequency of the product application but no treatment discontinuation
    - Very poor tolerance: subjective and/or physical signs leading to treatment discontinuation.
    Critères secondaires d’efficacité :
    - Evaluation par lecture centralisée de la disparition complète/presque complète de l’HI à S4, S8 et S24 par rapport à l’inclusion.
    - Evaluation qualitative sur site par l’investigateur
    . A chaque visite par rapport à l’inclusion pour l’évaluation de la disparition complète/presque complète.
    . A semaine 4, semaine 8, semaine 12 et semaine 24 par rapport à l’inclusion (échelle de 4 points : disparition complète, amélioration, stabilisation, aggravation).
    . A chaque visite par rapport à la visite précédente (échelle de 4 points : disparition complète, amélioration, stabilisation, aggravation).
    - Evaluation qualitative sur site par le(s) parent(s) ou tuteur(s) pour comparer chaque visite à la visite précédente
    .Evolution de l’HI (échelle de 4 points : disparition complète, amélioration, stabilisation, aggravation).

    Persistance du critère d’efficacité :
    - Persistance de la disparition complète/presque complète de l’HI à S24 par rapport à S12 basée sur les évaluations centralisées.
    - Evaluation qualitative de l’évolution de l’HI par l’investigateur (échelle de 4 points : disparition complète, amélioration, stabilisation, aggravation) à Semaine 24 (3 mois après l’arrêt du traitement).

    Critères de sécurité :
    Les critères de sécurité seront basés sur les évaluations suivantes :
    - Evènements indésirables
    - Taille, poids, périmètre crânien, température, fréquence cardiaque, pression artérielle, fréquence respiratoire, auscultation pulmonaire, palpation du foie et examens cliniques (à toutes les visites)
    - Tolérance locale
    . Très bonne tolérance : pas de signe subjectif ou clinique d’effet secondaire local
    . Bonne tolérance : signes subjectifs transitoires, sans signe clinique ou ne nécessitant pas la modification de la fréquence d’application du produit à l’étude
    . Mauvaise tolérance : signes subjectifs persistants ou signes cliniques d’effet secondaire local amenant la modification de la fréquence de l’application du produit à l’étude mais pas d’arrêt de traitement
    . Très mauvaise tolérance : signes subjectifs et/ou cliniques amenant l’arrêt du traitement
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy criteria: W4, W8, W12 and W24 compared to baseline
    Persistence of efficacy criteria: W24 compared to W12
    Critères secondaires d'efficacité : S4, S8, S12 et S24 par rapport à l'inclusion.
    Persistance du critère d’efficacité : S24 par rapport à S12
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Proof of concept
    Preuve de concept
    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 No
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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
    LVLS
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 80
    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.1.1.4.1Number of subjects for this age range: 80
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants
    Nourrissons
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    No treatment foreseen after the end of the study.
    Pas de traitement prévu après la fin de l'essai.
    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 Decision2011-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-09
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