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    Summary
    EudraCT Number:2015-000809-39
    Sponsor's Protocol Code Number:AA-HPP-405
    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:2015-08-05
    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 number2015-000809-39
    A.3Full title of the trial
    An Open-label, Multicenter, Expanded Access Program for Asfotase Alfa (human recombinant tissue-nonspecific alkaline phosphatase fusion protein) Treatment for Patients with Infantile- or Juvenile-onset Hypophosphatasia (HPP)
    Programme d’accès étendu multicentrique en ouvert pour le traitement par asfotase alfa (protéine de fusion recombinante humaine de la phosphatase alcaline non tissu-spécifique) de patients présentant une hypophosphatasie (HPP) infantile ou juvénile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Access Program for Asfotase Alfa
    Programme d’accès pour asfotase alfa
    A.4.1Sponsor's protocol code numberAA-HPP-405
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/176/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlexion Pharma International Sàrl
    B.1.3.4CountrySwitzerland
    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 supportAlexion Pharma International Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlexion Europe SAS
    B.5.2Functional name of contact pointEuropean Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1-15 avenue Edouard Belin
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33147100606
    B.5.5Fax number+33147100611
    B.5.6E-mailChomereau-LamotteC@alxn.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 Yes
    D.2.1.1.1Trade name Strensiq
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Pharma GK
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/594
    D.3 Description of the IMP
    D.3.1Product nameAsfotas Alfa
    D.3.2Product code ENB-0040
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNASFOTASE ALFA
    D.3.9.2Current sponsor codeENB-0040
    D.3.9.3Other descriptive nameHuman Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein
    D.3.9.4EV Substance CodeSUB168381
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Hypophosphatasia
    Hypophosphatasie
    E.1.1.1Medical condition in easily understood language
    Hypophosphatasia
    Hypophosphatasie
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10049933
    E.1.2Term Hypophosphatasia
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of subcutaneous (SC) injections of asfotase alfa administered 6 times weekly (at a dose of 1 mg/kg) or 3 times weekly (at a dose of 2 mg/kg) at the discretion of the Investigator.
    Évaluer la sécurité d’emploi et la tolérance des injections sous-cutanées (SC) d’asfotase alfa administrées 6 fois par semaine (à une dose de 1 mg/kg) ou 3 fois par semaine (à une dose de 2 mg/kg) selon l’avis du médecin l’investigateur.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of asfotase alfa on:
    1.Physical function
    2.Change in assistive device use for ambulation
    3.Growth as measured by change in height and weight Z-scores
    4.Change in the skeletal manifestations of HPP as measured by skeletal radiographs
    5.Overall survival
    6.Respiratory support as measured by respiratory support status
    Les objectifs exploratoires du programme incluent l’évaluation de l’effet de l’asfotase alfa sur :
    1.La fonction physique
    2.Les changements au niveau de l’utilisation d’un dispositif d’aide à la marche
    3.La croissance mesurée par la modification des scores-Z en termes de taille et de poids
    4.Les changements des manifestations squelettiques de l’HPP mesurés par des radiographies du squelette
    5.La survie globale
    6.L’assistance respiratoire mesurée par l’état de l’assistance respiratoire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for participation in this program:
    1.Parent or legal guardian must provide written informed consent prior to the performance of any program-related procedures and must be willing to comply with program procedures. Where appropriate and required by local regulations, patient assent for participation must also be obtained.
    2.Patient must have a documented diagnosis of HPP as indicated by a documented history of HPP-related skeletal abnormalities and one or more of the following:
    • Documented tissue-nonspecific alkaline phosphatase (TNSALP) gene mutation(s)
    • Serum alkaline phosphatase (ALP) level below the age-adjusted normal range AND plasma pyridoxal-5’-phosphate (PLP) above the upper limit of normal at Screening.
    3.Patient must have infantile- or juvenile-onset HPP, defined as documented onset of signs/symptoms of HPP prior to 18 years of age.
    4.Male patient is:
    • Prepubertal; OR
    • Surgically sterile (defined as vasectomized for ≥6 months at Baseline); OR
    • Non-surgically sterile (defined as non-vasectomized or vasectomized for <6 months at Baseline) and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) as described below starting at Baseline and continuing for 3 months after program completion.
    − Simultaneous use of condom, and for the female partner established use of hormonal contraceptives (eg, oral, injected, implanted) or intra-uterine contraceptive device
    − Simultaneous use of condom, and for the female partner occlusive cap (diaphragm or cervical/vault caps) with intravaginally applied spermicide5.Patient must have infantile- or juvenile-onset HPP, defined as documented onset of signs/symptoms of HPP prior to 18 years of age.
    5.Female patient is:
    • Of non-childbearing potential, defined as:
    − Prepubertal; OR
    − Post-menopausal (defined as absence of menses for 12 months prior to Baseline or bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to Baseline); OR
    − Surgically sterile (defined as having hysterectomy or tubal ligation at least 6 months prior to Baseline)
    OR
    • Of childbearing potential, and:
    − Not sexually active; OR
    − Sexually active with non-sterile male spouse/partner (sterile male spouse/partner defined as a man vasectomized for ≥6 months) and must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) as described below and continuing for 3 months after program completion.
    - Simultaneous use of hormonal contraceptives (eg, oral, injected, implanted) or intrauterine contraceptive device since at least 4 weeks prior to Baseline, and condom for the male partner
    - Simultaneous use of occlusive cap (diaphragm or cervical/vault caps) with
    intravaginally applied spermicide,
    6. Male patients who are pubertal or post-pubertal and not surgically sterile (surgically sterile defined as vasectomized for ≥6 months) must agree to not donate sperm during program participation and for 3 months after program completion.
    7.Female patients of childbearing potential (ie, those who are not prepubertal or post-menopausal or surgically sterile as defined in inclusion criteria 5 above) must have a negative urine or serum pregnancy test at Screening.
    Les patients doivent satisfaire à tous les critères d’inclusion suivants pour pouvoir participer à ce programme :
    1.Le patient ou le parent (ou le tuteur légal) doit fournir un consentement écrit avant toute procédure liée au programme et doit être disposé à se conformer aux procédures du programme. Si nécessaire et lorsque la réglementation locale l’exige, il faut également obtenir l’assentiment du patient pour sa participation.
    2.Le patient doit présenter un diagnostic documenté d’HPP tel qu’indiqué par un historique documenté d’anomalies du squelette associées à l’HPP et au moins un des critères suivants :
    •Mutation(s) documentée(s) du gène de phosphatase alcaline non spécifique au tissu
    •Niveau de phosphatase alcaline dans le sérum inférieur à la plage normale ajustée en fonction de l’âge ET niveau de phosphate de pyridoxal (PLP) dans le plasma supérieur à la limite supérieure de la normale lors de la sélection.
    3.Le patient doit présenter une HPP infantile ou juvénile, définie comme l’apparition documentée de signes/symptômes d’HPP avant l’âge de 18 ans.
    4.Le patient est :
    •prépubère ; OU
    •chirurgicalement stérile (vasectomisé depuis ≥ 6 mois au moment de la visite initiale) ; OU
    •non chirurgicalement stérile (défini comme un patient non vasectomisé ou vasectomisé depuis < 6 mois lors de la visite initiale) et son épouse/sa partenaire susceptible de débuter une grossesse doivent utiliser un moyen de contraception hautement efficace composé de deux méthodes de contraception (dont au moins une méthode barrière) telles que décrites ci-dessous dès la visite initiale et jusqu’à 3 mois après la fin du programme.
    -Utilisation simultanée d’un préservatif, et pour la partenaire, utilisation d’un contraceptif hormonal (par ex., oral, injecté, implanté) ou d’un dispositif intra-utérin
    -Utilisation simultanée d’un préservatif, et pour la partenaire, utilisation d’un pessaire occlusif (diaphragme ou cape cervicale/voûte vaginale) avec un spermicide à application intravaginale
    5.La patiente est :
    •Dans l’impossibilité d’avoir des enfants, définie comme suit :
    -prépubère ; OU
    -post-ménopausée (définie comme l’absence de menstruations pendant 12 mois avant la visite initiale, ou une ovariectomie bilatérale ou une hystérectomie avec ovariectomie bilatérale au moins 6 mois avant la visite initiale) ; OU
    -chirurgicalement stérile (avoir subi une hystérectomie ou une ligature des trompes au moins 6 mois avant la visite initiale)
    OU
    •susceptible de débuter une grossesse et :
    -n’est pas sexuellement active ; OU
    -est sexuellement active avec un époux/partenaire non stérile (époux/partenaire stérile défini comme un homme vasectomisé depuis ≥ 6 mois) et doit utiliser un moyen de contraception hautement efficace composé de deux méthodes de contraception (dont au moins une méthode barrière) telles que décrites ci-dessous, jusqu’à 3 mois après la fin du programme.
    Utilisation simultanée d’un contraceptif hormonal (par ex., oral, injecté, implanté) ou d’un dispositif intra-utérin depuis au moins 4 semaines avant la visite initiale, et d’un préservatif pour le partenaire
    Utilisation simultanée d’un pessaire occlusif (diaphragme ou cape cervicale/voûte vaginale) avec un spermicide à application intravaginale, et d’un préservatif pour le partenaire depuis au moins 14 jours avant la visite initiale
    6.Les patients pubères ou post-pubères qui ne sont pas chirurgicalement stériles (la stérilisation chirurgicale étant définie comme une vasectomie depuis ≥ 6 mois) doivent accepter de ne pas donner leur sperme pendant leur participation au programme et jusqu’à 3 mois après la fin du programme.
    7.Les patientes susceptibles de débuter une grossesse (c’est-à-dire, qui ne sont pas prépubères, post-ménopausées ou chirurgicalement stériles tel que défini dans le critère d’inclusion 5 ci-dessus) doivent présenter un test de grossesse urinaire ou sérique négatif à la sélection.
    E.4Principal exclusion criteria
    Patients will be excluded from participation in this program if they meet one or more of the following exclusion criteria:
    1.Patient has geographic access to and qualifies for enrollment (as determined by the Sponsor and Investigator) in any other Alexion-sponsored clinical trials of asfotase alfa that are open to enrollment (eg, ENB-010-10).
    2.Patient is pregnant, trying to become pregnant, or is lactating.
    3.Patient has a documented sensitivity to any of the components of asfotase alfa.
    4.Patient has serum calcium and/or phosphorus levels below the normal range at Screening.
    5.Patient is currently enrolled in any other program or study involving an investigational new drug, device, or treatment for HPP (eg, bone marrow transplantation).
    6.Patient has any other medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with program compliance, including all evaluations and follow-up activities.
    Les patients ne pourront pas participer à ce programme s’ils répondent à au moins l’un des critères d’exclusion suivants :
    1.Le patient peut accéder géographiquement et est éligible pour le recrutement (tel que déterminé par le promoteur et le médecin investigateur) dans n’importe quel autre essai mené par Alexion sur l’asfotase alfa en cours de recrutement (par ex. ENB-010-10).
    2.La patiente est enceinte, souhaite le devenir ou allaite.
    3.Le patient présente une sensibilité documentée à l’un des composants de l’asfotase alfa.
    4.Le patient présente des niveaux sériques de calcium et/ou de phosphore inférieurs à la normale lors de la sélection.
    5.Le patient est actuellement inclus dans un autre programme ou une autre étude impliquant un nouveau médicament, dispositif ou traitement de l’HPP expérimental (par ex. greffe de moelle osseuse).
    6.Le patient présente un autre problème médical, une maladie intercurrente grave ou une autre circonstance atténuante qui, de l’avis du médecin investigateur, peut interférer de façon significative avec les exigences du programme, notamment toutes les évaluations et activités de suivi.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the safety and tolerability of subcutaneous (SC) injections of asfotase alfa administered 6 times weekly (at a dose of 1 mg/kg) or 3 times weekly (at a dose of 2 mg/kg)
    Évaluer la sécurité d’emploi et la tolérance des injections sous-cutanées (SC) d’asfotase alfa administrées 6 fois par semaine (à une dose de 1 mg/kg) ou 3 fois par semaine (à une dose de 2 mg/kg) selon l’avis du médecin l’investigateur.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study duration
    Durée de l'étude
    E.5.2Secondary end point(s)
    evaluation of the effect of asfotase alfa on:
    1.Physical function
    2.Change in assistive device use for ambulation
    3.Growth as measured by change in height and weight Z-scores
    4.Change in the skeletal manifestations of HPP as measured by skeletal radiographs
    5.Overall survival
    6.Respiratory support as measured by respiratory support status
    L’évaluation de l’effet de l’asfotase alfa sur :
    1.La fonction physique
    2.Les changements au niveau de l’utilisation d’un dispositif d’aide à la marche
    3.La croissance mesurée par la modification des scores-Z en termes de taille et de poids
    4.Les changements des manifestations squelettiques de l’HPP mesurés par des radiographies du squelette
    5.La survie globale
    6.L’assistance respiratoire mesurée par l’état de l’assistance respiratoire
    E.5.2.1Timepoint(s) of evaluation of this end point
    Physical function, Respiratory support status and Physical examination (including length/height and weight) : at screening, day 1, week 4, week 12, week 24, every 6 months and EOP
    Ambulatory assistive devices assessments: day 1, week 12, week 24, every 6 months and EOP
    Skeletal radiographs: Day1, performed as part of standard of care and as clincally indicated
    Overall survival : study duration
    La fonction physique, l'état de l'assistance respiratoire et l'examen physique (comprenant la longueur/hauteur et le poid) : à la sélection, jour 1, semaine 4, semaine 12, semaine 24, tous les 6 mois et à la fin de l'étude
    L'utilisation d'un dispositif d'aide à la marche: jour 1, semaine 12, semaine 24, tous les 6 mois et à la fin de l'étude
    Radiographie du squelette: jour 1, réalisée comme faisant partie du traitement standard et si cliniquement indiquée
    La survie globale: durée de l'étude
    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 Yes
    E.6.13.1Other scope of the trial description
    Treatment access program for HPP patients
    Programme d'acces au traitement pour les patients souffrant d'hypophosphatasie
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Netherlands
    Russian Federation
    Spain
    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
    end participation of individual patients in this program at the time asfotase alfa becomes approved and commercially available in their country of enrollment, the patient is determined eligible for an actively enrolling Alexion-sponsored clinical trial of asfotase alfa, or other qualifying event occurs
    fin de l'étude lorsque l'asfotase alfa sera soit approuvé et commercialisé dans le pays où le patient aura été inclus, jusqu’à ce que le patient soit défini comme étant éligible pour un essai clinique sur l’asfotase alfa mené par Alexion en phase de recrutement active ou jusqu’à ce qu’un autre événement qualificatif survienne
    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 months0
    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 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.1.1Number of subjects for this age range: 120
    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: 24
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 24
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    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 Yes
    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
    Parent or legal guardian
    Parent ou représentant légal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 100
    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)
    return to standard of care
    retour au traitement de référence
    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 Decision2015-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-08
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